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THE SHORT-TERM EFFECT OF A ROLLATOR ON FUNCTIONAL EXERCISE CAPACITY IN INDIVIDUALS WITH SEVERE CHRONIC OBSTRUCTIVE PULMONARY DISEASE Sherra Beth Solway A thesis submitted in conformity with the requirements for the degree of Masten of Science Graduate Department of Rehabilitation Science, University of Toronto @Copyright By Sherra Beth Solway 2001

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Page 1: THE SHORT-TERM EFFECT OF A - University of Toronto T · PDF fileThe Short-Term Effect of a Rollator on Functional Exercise Capacity in Individuals ... for sharing her knowledge,

THE SHORT-TERM EFFECT OF A ROLLATOR ON FUNCTIONAL EXERCISE

CAPACITY IN INDIVIDUALS WITH SEVERE CHRONIC OBSTRUCTIVE

PULMONARY DISEASE

Sherra Beth Solway

A thesis submitted in conformity with the requirements

for the degree of Masten of Science

Graduate Department of Rehabilitation Science,

University of Toronto

@Copyright By Sherra Beth Solway 2001

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National Library of Canada

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The author retains ownership of the copyright in this thesis. Neither the thesis nor substantial extracts fiom it may be printed or otherwise reproduced without the author's permission.

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ABSTRACT

The Short-Term Effect of a Rollator on Functional Exercise Capacity in Individuals

with Severe Chronic Obstructive Pulmonary Disease

Sherra Beth Solway, M.Sc. (2001)

Graduate Department of Rehabilitation Science

University of Toronto

Purpose: This study was conducted to examine the effect of a rollator on functionai exercise

capacity in individuals with severe COPD and to determine which individuals would benefit

most from using a rollator. Methods: 40 subjects were studied on wo separate days in the

same week. Two six-minute walk tests (6MWTs) were performed on each day. One 6MWT

was performed unaided and the other using a rollator, with the order of the test randomized

on the fint day and revened on the second. Results: There was a significant reduction in

modified Borg rating of dyspnea (pe0.001) and duration of rest (p=0.001) with use of the

rollator. For subjects who walked less than 300 meten unaided, there was also a significant

improvement in distance waked (p4.02). Requirement of a rest during the unaided 6MWT

was the only significant predictor variable for irnprovement in functional exercise capacity

with use of the rollator (p<0.005). Conclusions: Rollators are effective in improving

fùnctional exercise capacity by reducing perception of dyspnea and rest duration in

individuals with severe COPD. hdividuals who walk less than 300 meters ancilor who

require a rest during an unaided 6 W will benefit most kom using a rollator in ternis of

reductions in breathlessness and rest time and an improvement in distance walked.

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In Loving Memory of iny Nana M d y

. S .

I l l

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ACKNOWLEDGEMENTS

During the process of this research project, many individuals gave time, guidance and emotional support. To al1 of these people, 1 offer my sincere gratitude and appreciation.

My special thanks to:

Dr. Dina Brooks, for sharing her knowledge, expertise and own expenences; for coaching me through each stage of my studies; and for providing encouragement when I rnost needed it. Without her guidance, participation and mentoring, this endeavor would not have been possible;

Drs. Cheryl Con, Roger Goldstein and Scott Thomas, for sharing thcir expertise, reviewing my thesis and providing constructive feedback;

Dr. Scott Thomas, in his role as Graduate Coordinator, for his understanding, support, guidance and encouragement;

Louis Lau for his technical expertise and knowledge and his assistance and contributions to the study;

David I. Wang, for his assistance with data analysis,

Donna Clow for her support, kindness and assistance with subject recruitment;

The Day Hospital, 2WF and Respiratory Medicine staff at West Park Health Hospital for their support and assistance;

Glavo Wellcome, The Clinical Evaluation and Research Unit at West Park Hospital, the Ontario Ministry of Education and Training, the Ontario Respiratory Care Society and the Canadian Physiotherapy Cardiorespiratory Society for their financial support;

My brother Lome, for his words of encouragement and unwavering support;

And finally, the individuals who participated in this study, for their time, kindness and genuine desire to help othen.

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ABBREVIATIONS

SMWT

6MWT

ISMWT

ABG

ANOVA

ATS-DLD

BDI

bpm

CF

cm

CI

cm

COPD

CHQ

CRQ

DLCO

EMG

ESLD

FEV,

FRC

FVC

ICC

Two-Minute Walk Test

Six-Minute Walk Test

Twelve-Minute Walk Test

Arteriai BIood Gases

Analysis of Variance

Amencan Thoracic Society. Division of Lung Diseases

Baseiine Dyspnea Index

beats per minute

Cystic Fibroçis

Congestive or Chmnic Head Failure

Confidence Interval

Centimeters

Chronic Obstructive Pulmonary Disease

Chronic Heart Failure Questionnaire

Chronic Respiratory Disease Questionnaire

Difision Capacity of Carbon Monoxide

Electromyography

End Stage Lung Disease

Forced Expiratory Volume in One Second

Functional Residual Capacity

Forced Vital Capacity

Intra-Class Correlation Coefficient

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NC

Kg

m

min

ME'

mL

MRC

L

NYHA

NPV

NR

NS

0 2

P m

PaOr

PEFR

PFT

PPV

r

R

ROC

RPE

RV

Inspiratory Vital Capacity

Kilograms

Meters

Minutes

Maximal lnspiratory Pressure

Millilitres

Medical Research Council

Litres

New York Heart Association

Negative Predictive Value

No Rollator

Not Signi ficant

Ox y gen

Peripheral Merial Disease

Partial Pressure of Oxygen

Peak Expiratory Flow Rate

Pulmonary Function Tests

Positive Predictive Value

Pearson's Correlation Coefficient

Rollator

Receiver Operating Charactenstic

Rating of Perceived Exertion

Residual Volume

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SAS

SD

SE

SGRQ

SIP

SOLVD

TLC

VAS

VC

VE

VI

VO2

VOzmav

WI

VVIR

Wmaii

wrt

Percent Saturation of Hemoglobin with Oxygen in Artenal

Blood

Specific Activity Scde

Standard Deviation

S tandard E rro r

Si. George's Respiratory Diseases Questionnaire

Sickness impact Profile

Studies of Lefi Ventricular Dysfunction

Total Lung Capacity

Visual Analogue Scale

Vital Capacity

Minute Ventilation

Virtual Instrument

Oxygen Consumption

Maximal Oxygen Consumption

Fixed Rate Response

Optimal Rate Response

Maximal Work Capacity

With Respect To

vii

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Pape Number

Abstract Acknowledgernents Ab breviations List of Tables List of Figures List of Appendices

Chapter 1 : Introduction and Review of Literature

1.1 Background and Purpose of Study

l .Z Chronic Obstructive Puimonary Disease (COPD): An Overview 1.2.1 Review and Definition of COPD 1.2.2 Prevalence of COPD 1.2.3 Pathophysiology of COPD 1.2.4 Respiratory Rehabilitation in COPD

1.3 Use of Wheeled Walkers and Roliators 1.3.1 Wheeled Walkers and Rollators in Individuals with

COPD 1.3.2 Wheeled Walkers and Rollators in Older Adults and

the Elderly 1.3.3 Potential Mechanisms of Improvernent in Functional

Exercise Capacity with Use of a Wheeled Walker or Rollator

1.3.4 Summary

Walk Test Measures of Functional Exercise Capacity in lhdividuals with Cardiorespiratory Disease

1.4.1 Definition 1.4.2 Two-Minute Walk Test 1.4.3 Six-Minute Walk Test 1.4.4 Twelve-Minute Walk Test 1.4.5 Factors Affecting Performance 1.4.6 Summary

. . i l

iv v xi xii ~ i v

1.5 Research Questions and Hypotheses

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Chapter 2: Methods 36

2.1 Subjects 2.1.1 Sampling and Recruitrnent 2.1.2 Inclusion and Exclusion Criteria

2.2 Study Design 37 2.2.1 ProtocoI 37 2.2.2 Data Acquisition 39 3.2.3 Measures 42

2.2.3.1 Primary Measures 42 2.2.3.1 a Six-Minute Walk Test Distance 42 2.2.3.1 b Modified Borg Rating of Dyspnea 43

2.2.3.2 Secondary Measures 44 2.2.3.2a Measures of Cardiorespiratory Function 44

2.2.3.2ai Ventilatory Variables 44 2.2.3.2aii Oxygen Saturation and 46

Heart-Rate 2.2.3.3b Measures of Gait 47

2.2.3.2bi Number of Stides/Stride Length 47 2.2.3.2bii Overall Walking Speed 47 2.2.3.2biii Modified Borg Ratings of Leg 47

Discom fort 2.2.3.3 Explanatory Descriptive Measures 48

2.2.3.3a Upper Extremity Weight-Bearing 48 2.2.3.3b Subject Preference 49 2.2.3.3~ Health-Related Quality of Life 49

2.2.4 Data Processing 50 2.2.5 Statistical Analysis 5 1

Chapter 3: Results 53

3.1 Sample Characteristics 53

3.2 Prirnary Outcomes 3 2.1 Six-Minute Walk Test Distance 3 2.2 Duration of Rest 3.2.3 Modified Borg Rating of Dyspnea

3.3 Secondary Outcomes 3.3.1 Cardiorespiratory Function

3.3.1.1 Ventilatory Variables 3.3.1.2 Oxygen Saturation and Heart-Rate

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3.3.2 Gait 67 3.3.2.1 Stride Length 67 3.3.2.2 Overall Walking Speed 67 3.3.2.3 Modified Borg Rating of Leg Discornfort 72

3.4 Explanatory Descriptive Measures 72 3.4.1 Baseline (Le. Unaided) Six-Minute Walk Test Distance 72 3 .4.2 Upper Extremity Weight-Bearing 75 3.4.3 Subject Pre ference 78 3 4.4 Univariate Regression Analysis 79 3.4.5 Mulivariate Regression Analysis 80

Chapter 4: Discussion 82

4.2 Cornparisons to Other Studies 83

1.3 Research Questions 1 & 2 - Determining the Effect of a Rollator on 86 Functional Exercise Capacity and Individuals Who Benefit Most 4.3.1 Clinical Implications of Findings 88

4.4 Research Question 3 - Insight into Mechanisms 89

4.5 Limitations 93

Chapter 5: Conclusions and Recommendations for Future Research 96

5.1 Conc luding Remarks 96

5.2 Future Researcti 96

REFERENCES 98

APPENDICES 111

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LIST OF TABLES

Table Descri~tion Pape

Guidelines for hterpreting FEV

Studies of Psychometric Properties of the Two-Minute Walk Test.

Studies of Psychometric Properties of the Six-Minute Walk Test in Patients with Chronic Obstructive Pulmonary Disease.

Studies of Psychometric Properties of the Six-Minute Walk Test in Patents with Heart Failure.

Other Studies of Psychometric Properties of the Six-Minute Walk Test.

Studies of Psychometric Properties of the Twelve-Minute Walk Test.

Surnmary of the Evidence for the Psychometric Properties of the Two, Six, and Twelve Minute Walk Tests.

Data Acquisition Channels.

Classification of Measures.

General Characteristics of Sarnple.

Pre- and Post-Test Ratings of Dyspnea Using the Modified Borg Scale

Amount of Upper Extremity Weight-Bearing Dunng Each Minute of the Six-Minute Walk Test.

Agreement with Statements Pertaining to Use of the Rollator During the Six-Minute Walk Test for the Total Sarnple.

Subject Preference Categorized According to Level of Disability

Univariate Regression Analysis Between Potential Predictor Variables and Improvement in Functional Exercise Capacity with Rollator

Multiple Regression Analysis Between Predictor Variables Identified with Simple Linear Regression and Improvement in Functional Exercise Capacity with Rollator.

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LIST OF FIGURES

Fipu - r e Descri~tion Pape

1 Photograph of tester's trolley set-up with monitoring and acquisition equiprnent.

Comparison of total distance walked unaided and with the rollator.

3 Distance walked unaided and with the rollator for each minute of the six-minute walk test for the total sarnple and for subjects who walked less than and greater than 300 meten unaided

4 Cornparison of duration of rest during the six-minute walk test when walking unaided and with the rollator.

5 Cornparison of change in perception of dyspnea when walking unaided and with the rollator.

6 Cornparison of respiratory rate during the six-minute walk test when walking unaided and with the rollator.

Cornparison of the phase relationship of the nb cage and abdomen during the six-minute walk test when walking unaided and with the rollator.

Comparison of minute volume during the six-minute walk test when walking unaided and with the rollator.

Comparison of the ratio of the contribution of breathing of the rib cage to the abdomen during the six-minute walk test when walking unaided and with the rollator.

Comparison of oxygen saturation during the six-minute walk test when walking unaided and with the rollator.

Comparison of heart-rate during the six-minute walk test when walking unaided and with the rollator.

Cornparison of stride length during the six-minute walk test when walking unaided and with the rollator.

Comparison of overall w&g speed during the six-minute walk test when walking unaided and with the rollator.

xii

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Fipure des cri^ tion Pape

14 Cornparison of change in perception of leg discomfort when walking unaided and with the rollator.

15 Scatter plot showing the relationship between baseline measure of disability and change in distance waiked with the rollator.

16 Relationship between amount of weight applied to rollator and change in distance waiked with the rollator.

17 Relationship between amount of weight applied to rollator and change in perception of dyspnea with the rollator.

I Voltage spikes denoting contact of heel with ground during ambulation.

II Relationship between known weights applied to rollator and output of weight-bearing sensing mechanism.

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LIST OF APPENDICES

Amendix Descri~tion Pape

1 Eligibility Screening Form 111

7 - Subject Information Sheet and Informed Consent Form 113

Data Collection Forrn

Modified Borg Scale

Equations for Respiratory inductance Plethysmography 121 CaIibration

6 Stride Sensor Output 123

7 Validation of Weight-Bearing Sensing Mechanism. 125

8 Subject Preference Questionnaire 127

9 St. George's Respiratory Questionnaire 130

10 Calculation Procedure for Phase Angles 136

11 Normal Respiratory Data 138

xiv

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Chapter 1: Introduction and Review of Literature

1.1 Backpround and Pur~ose of Studv -

The purpose of this study was to: 1) evaluate the short-term effect of using a rollator

on hct ional exercise capacity in individuals with Chronic Obstructive Puhonary Disease

(COPD), 2) assess which individuals with COPD would benefit most fiom using a rollator

and 3) examine the underlying rnechanisms that may contribute to change in functional

exercise capacity with use of a rollator. In this introduction, I will provide overviews of

COPD, wheeled walking aids and functional waik tests and will discuss the background and

rationale for this work.

1.2 Chronic Obstructive Pulmouarv Disease (COPD): An Overview -

1.2.1 Review and Definition of COPD

COPD is a chronic, slowly progressive disease characterized by irrevenible airfiow

obstruction secondaiy to chronic bronchitis and/or emphysema (Canadian Respiratory

Review Panel, 1998; The COPD Guidelines Group, 1997; Jenkins et al., 1995; Siafakas et al.,

1995). Cigarette smoking and exposure to tobacco smoke are the primary causes of COPD

(Canadian Respiratory Review Panel, 1998; The COPD Guidelines Group, 1997; Jenkins et

al., 1995; Siafakas et al., 1995). Chronic bronchitis is defined in dinical terms as the

presence of a productive cou& for at least three months per year for a minimum of two

consecutive years. in contrast, emphysema is defined in pathological ternis as enlargement

and destruction of the alveoli and respiratory bronchioles (Canadian Respiratory Review

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Panel, 1998; Siafakas et al., 1995). Most individuals with COPD have some combination of

chronic bronchitis and emphysema (Harnmon & Hasson, 1996). Other specific causes of

airflow limitation such as cystic fibrosis, asthma, bronchiectasis and bronchiolitis obliterans

are not included in the definition of COPD by convention (Canadian Respiratory Review

Panel, 1998; Siafakas et al., 1995). However, many individuals with COPD have some

degree of revenible ainvay obstruction secondary to inflammation (Canadian Respiratory

Review Panel, 1998; Murray & Petty, 1996; Siafakas et al., 1995).

A diagnosis of COPD requires a history of progressive cough, wheeze or dyspnea and

objective evidence (i.e. spirometic testing) of airway obstruction that does not retum to

normal with treatrnent (Canadian Respiratory Review Panel, 1998; The COPD Guidelines

Group, 1997; Jenkins et al., 1995). There are three stages of COPD; namely, mild, moderate

and severe. Forced expiratory volume in one second (FEV,) is the accepted guide to

diagnosis and severity of COPD and is defined as the maximal volume of air exhaled during

the fint second (Amencan Thoracic Society, 1999; The Canadian Respiratory Review Panel,

1998; The COPD Guidelines Group, 1997). Individuals with COPD show a decline in FEVl

of approximately 48-91mL per year (Kim et al., 1991; Snider et al., 1985), which is

significantly higher than the normal rate of decline due to aging, Le. 20-30mL per year

(Canadian Respiratory Review Panel, 1998; Siafakas et al., 1995). Although, ihere is general

acceptance that a FEVl of less than 35% predicted is representative of severe airway disease,

curent guidelines for interpreting FEVi are conflicting (The COPD Guidelines Group, 1997;

Amencan Thoracic Society, 1995; Siafakas et al., 1995). These guidelines are shown in table

1.

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Table 1: Guideünes for Interpreting FEV,

1 Author 1 Mild COPD 1 Moderate COPD 1 Severe COPD

Il American Thoracic 1 FEV, 2 50% predicted FEV, 35-49% predicted FEVl < 35% Societv. 1995 1 1 ~redictcd

II Siafakas et al.. 1995 1 FEV, 2 70% predicted 1 FEV, 50-69% predicted 1 FEVl < 50%

COPD Guidelines

Clinically, individuals with mild COPD tend to be asymptomatic or present with rnild

symptoms such as rnorning cough, recurrent respiratory infections or shortness of breath with

significant exertion (Canadian Respiratory Review Panel. 1998; The COPD Guidelines

Group, 1997). Individuals with moderate COPD can present with cough and sputurn

production, dyspnea on moderate exertion, signs of hypennflation and/or recurrent

exacerbations (Canadian Respiratory Review Panel, 1998; The COPD Guidelines Group,

1997). Finally, individuals with severe COPD tend to be disabled by severe dyspnea at rest

or with minimal activity. These individuals typically experience recurrent exacerbations,

which are often complicated by respiratory andior heart failure (Canadian Respiratory

Review Panel, 1998; The COPD Guidelines Group, 1997). In al1 stages of COPD, dyspnea is

the primary activity limiting symptom leading to reduced functional ability. (Jenkins et al.,

1995; Breslin, 1992).

There is no cure for COPD; however, disease progression and clinical detenoration

can be slowed by several management strategies including smoking cessation, dmg therapy

(Le. bronchodilaton, corticosteroids), nutrition, influenza vaccinations, oxygen therapy and

respiratory rehabilitation (Canadian Respiratory Review Panel, 1998; The COPD Guidelines

predicted

Group of the Standards of Care Cornmittee of the , BTS, 1997

FEV, 60-79% predicted FEV, 40-59% predicted F E V V 1 4 0 % predicted

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Group, 1997; Jenkins et al., 1995; Siafakas et al., 1995). There are various published clinical

practice guidelines on the assessrnent and management of COPD; however, differences exist

with respect to content and emphasis (Lacasse et al., In Press; Jones, 1999).

1.2.2 Prevalence of COPD

There is evidence for the increasing economic and social burden of COPD resulting

from its increasing prevalence and significant morbidity (Calverley, 2000a). COPD is the

fifth leading cause of death in North Amenca (Canadian Respiratory Review Panel, 1998;

Canadian Thoracic Society Workshop Group, 1992; Feinleib et al., 1989). A recent analysis

of trends in the epidemiology of COPD in Canada estimated that 750,000 Canadians had

chronic bronchitis or emphysema diagnosed by a health care professional (Lacasse et al.,

1999). Prevalence rates for 1994 to 1995 were estimated to be 4.7% for individuals aged 55

to 64 years, 5.4% for individuals aged 65 to 74 years and 8.3% for those 75 years of age and

older (Lacasse et al., 1999). The prevalence o f the disease was f o n d to be higher for men

then women in al1 age categories (Lacasse et al., 1999). Given that there has been an

increase in female srnoken, the prevalence of COPD in women will continue to nse

(Canadian Respiratory Review Panel, 1998). Similar epidemiological findings have been

reported in the United States and Europe (Gulsvik, 1999; National Centre for Health

Statistics, 1993).

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1.2.3 Pathophysiology of COPD

The bronchial tree and alveoli are the sites of pathological changes that occur with

COPD (The COPD Guidelines Group, 1997). The small bronchi and bronchioles are the

main areas of airflow resistance (Siafakas et al., 1995). The pathophysiologic processes

associated with COPD include inflammation of the airways, enlarged submucosal glands and

goblet ce11 hyperplasia resulting in mucosal hypenecretion and ciliary dysfunction, and

proteolytic destruction of the alveoli and comective tissue framework of the lung (Jenkins et

al., 1995; Siafakas et al., 1995; Canadian Thoracic Society Workshop Group, 1992). As a

result of these changes, airway diameten narmw, elastic recoil of the lungs is lost and small

ainvay collapse is potentiated. Therefore, airflow limitation and hypennflation occur

(Jenkins et al., 1995; Siafakas et al., 1995; Canadian Thoracic Society Workshop Group,

1992). An individual's clinical presentation is determined by the pathological processes that

predominate (Siafakas et al., 1 995).

Changes also occur in the pulmonary circulation and in severe disease, in the right

heart (Siafakas et al., 1995). Airflow limitation and alveolar darnage results in a mismatch of

ventilation and perfusion, which therefore impairs gas exchange (Siafakas et al., 1995).

Chronic impairnent of gas exchange can lead to polycythemia and vasoconstriction with a

resultant increase in vascular pulrnonary resistance (Siafakas et al., 1995; Snider et al., 1994).

Pulmonary hypertension may result in enlargement and failure of the nght ventncle of the

heart (Le. cor pulmonale) (Canadian Respiratory Review Panel, 1998; Murray & Petty,

1996).

Lastly, individuals with COPD show distinguishing changes in lung volumes.

Functional residual capacity (FRC), residual volume (RV) and the ratio of RV to total lung

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capacity (TLC) increase while vital capacity (VC) diminishes (Siafakas et al., 1995). FRC

increases because of the loss of lung elastic recoil and due to dynamic factors at the end of

expiration, especially when ventilation is increased (Siafakas et al., 1995; Stubbing et al.,

1980). Specifically, because of airflow limitation, the rate of expiration is slowed and the

time between subsequent inspirations does not allow full expiration to occur (O'DomelI,

1998; Siafakas et al., 1995). The term "dynamic pulmonary hypennflation" is used to

describe ihis process (O'Donnell, 1998; Siaf 'as et al., 1995). The hypennflation results in

increased work of breathing and higher energy consurnption of the inspiratory muscles than

in healthy individuals (Siafakas et al., 1995). Additionally, the function of the diaphragrn

and other inspiratory muscles becomes cornpromised because of unfavorable length tension

relationships (O'Donnell, 1998; Delgado et al., 1982).

1.2.4 Respiratory Rehabilitation in COPD

Respiratory rehabilitation is a therapeutic approach provided by an interdisciplinary

team of health care professionals and directed to penons with respiratory disease and their

farnilies (Fishman, 1994). Typical components inciude patient and family education, aerobic

exercise, breathing retraining, upper extremity endurance and strengthening exercises, energy

conservation and psychosocial support (Arnencan Thoracic Society, 1999; Lacasse et al.,

1997a; Ries et al., 1995; Canadian Thoracic Society Workshop Group, 1992). Prograrns are

usuaily of at least four weeks duration and occur in both hospital based (i.e. in-patient and

out-patient) and cornmunity based settings (American nioracic Society, 1999; Lacasse et al.,

1996). Lacasse and colleagues (1996) established the efficacy of respiratory rehabilitation

(i.e. programs of at least 4 weeks duration with or without education andfor psychosocial

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support) on functional exercise capacity and health-related quality of life in individuals with

COPD using a rneta-analysis.

Exercise training has been shown to be fundamental to respiratory rehabilitation

(Arnerican Thoracic Society, 1999; Lacasse et al., 1997a; Lacasse et al., 1996). Most

respiratory rehabilitation prognms emphasize endurance training at levels of 60% of

maximal workload; for those who cannot tolerate this intensity, interval training is utilized

(Arnerican Thoracic Society, 1999). Although upper extremity endurance training has been

shown to be effective in improving arm function, few studies have evaluated the

effectiveness of strength training in individuals with COPD (Arnerican Thoracic Society,

1999; Lacasse et al., 1997a)

The additional benefit of breathing retraining, education and psychosocial support to

exercise training is not well evidenced (American Thoracic Society, 1999; Lacasse et al.,

1997a). The effectiveness of inspiratory muscle training and other breathing exercises as an

adjunct to exercise training for individuals with COPD is uncertain and the contribution of

education has not been well addressed in the literanire (American Thoracic Society, 1999;

Lacasse et al., 1997a). Dyspnea management strategies alone have not been s h o w to be

effective in improving dyspnea, exercise capacity or health-related quality of life (Lacasse et

al., 1997a). Psychosocial support has been shown to have a positive short-term effect on

dyspnea and when incorporated into a respiratory rehabilitation program, may promote

cornpliance with exercise training and improve health-related quality of life (Lacasse et al.,

1997a).

The primary goal of respiratory rehabilitation is for individuals to achieve and

maintain their maximum level of independence and functioning in the community (Fishman,

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1994). As a result of their severe disease, individuals with COPD are often disabled due to

dyspnea and poor functional exercise capacity (Canadian Respiratory Review Panel, 1998).

These individuals tend to adopt sedentary lifestyles which results in M e r deconditioning,

worsening of symptoms and reduced quality of life (Canadian Respiratory Review Panel,

1998). The underlying rationale for respiratory rehabilitation is to prevent deconditioning

and allow an individual to cope with hidher disease (The COPD Guidelines Group, 1997).

Walking is an important, useful and preferred form of exercise for rnost individuals

with COPD (American Thoracic Society, 1999; Murray & Petty, 1996). As such, it is

incorporated into the majority of respiratory rehabilitation programs by means of evaluation

and treamient (Brooks et al., 1999; Murray & Petty, 1996; Siafakas et al., 1995; Canadian

Thoracic Society Workshop Group, 1992). in those individuals with severe lung disease, a

wheeled walking aid is oflen used for the walking component in order to reduce dyspnea and

improve hct ional capacity (Honeyman et al., 1996). However, there is limited literature on

the effectiveness of walking aids for individuals with COPD.

1.3 Use of WheeIed Walkers and Rollators -

Ambulatory aids such as wheeled walken and rollaton can be used to reduce walking

disability in individuals with COPD and the elderly (Comely, 1998; Roomi et al., 1998;

Verbrugge et al., 1997; Honeyman et al., 1996; Wesmiller & H o h a n , 1994). Wheeled

walkers are wdker Frames with two, three or four standard wheels. While a rollator is also

considered a walker with four wheels, the front two wheels typically are on swivel castes for

easy maneuverability (Comely, 1998). Additionally, unlike regular wheeled waiken,

rollaton are equipped with hand brakes, a basket for carrying objects and a fold-dom seat

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that allows an individual to rest at any place or time. Although the superionty of wheeled

waiken to standard waiken (i.e. without wheels) for improving functional ability is

evidenced in the literature (Bohannon, 1997; Medley & Thompson, 1997; Foley et al., 1996;

Harnzeh et al., 1988). the use and effect of wheeled walkers and rollaton on functional

capacity and activities of daily living has not been extensively studied.

1.3.1 Wheeled Walkers and Roltators in Individuals with COPD

Only five fùlly published reports and one abstract could be f o n d on the effeci of

wheeled waiking aids in individuals with COPD. In 1957, Campbell descnbed the effect of

leaning on a modified "dressing trolley" on exercise tolerance in one individual with severe

emphysema. A six to ten-fold increase in exercise tolerance was reported. Similarly, in

1972, Grant and Cape1 studied the effect of a wheeled walking aid in five individuals with

severe pulmonary emphysema. These authors found a two-fold increase in walking distance

associated with a twenty-nine percent reduction in walking velocity and no significant

change in minute ventilation. The improvement in w a k n g distance was achieved by an

increase in endurance as subjects were not limited by time. In contrast, Wesmiller and

H o f i a n (1994) found no statisticaily significant change in waUUng distance with the use of

an assistive device with wheels in twelve oxygen-dependent men with severe COPD.

However, a significant difference in waiking distance was f o n d in a subgroup of six

individuals who were the most disabled (twelve-minute walk test distance less than 1000

feet). Although this study utilized a modified version of the twelve-minute walk test and a

standardized instruction protocol, repeated measurements of w a h g distance to control for

order and day were not perforrned nor were measurements of dyspnea or oxygenation taken.

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Furthemore, the height of the mobility aid was adjusted for cornfort rather than being

standardized. In an abstract by Dalton and colleagues (1995), the use of a wheeled walker

was reported to result in a significant reduction in dyspnea in ten individuals with severe

COPD; however, no significant change in six-minute waik test distance or oxygen saturation

was observed. A more recent study by Honeyman and colleagues (1996) exarnined the effect

of a rollator on distance walked, oxygen saturation and breathlessness using a six-minute

walk test. In their sarnple of eleven individuals with significant disability (i.e. six-minute

walk test distance less than 300 meters) secondary to severe COPD, the use of a rollator

resulted in a statistically significant increase in six-minute walking distance (Le. 33.6

meten), reduction in hypoxemia (Le. 2.2%) and decrease in dyspnea (i.e. 1.3 units) as

determined by the modified Borg scale. Five of these subjects required oxygen for exertion

and were required to pull their oxygen canister during their unaided walk only. Improvement

with use of the rollator may have occurred because of a reduction in the metabolic cost of

activity in individuals using oxygen not having to pull their portable cylinder (Honeyman et

al, 1996). Finally, Roomi and colleagues (1998) compared walking unaided with three

different mobility devices (Le. standard walker, rollator, and hi&-wheeled walker) in twenty-

seven elderly individuals with COPD. They found that only the high-wheeled walker had a

positive effect on six-minute walk test distance and oxygen saturation.

In summary, the available literature on the effectiveness of wheeled walking aids in

individuals with COPD is not extensive and conflicting. Given that most individuals with

COPD are greater than fi@-five years of age (Lacasse et al., 1999; Murray & Petty, 1996),

the literature on the use of wheeled walking aids in older adults and the elderly will also be

examined.

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1.3.2 Wheeled Walkers and Rollators in Older Adults and the Elderly

Four studies were f o n d comparing and evaluating the effects of wheeled waiken on

fùnctional ability in older adults and the elderly. A study by Mahoney and colleagues (1992)

compared performance with a two venus a three-wheeled walker in a sample of elderly

subjects and showed that the three-wheeled walker resulted in longer stnde lengths and faster

obstacle course coverage. In 1993, a study by Tideiksaar compared a two-wheeled walker

and a four-wheeled walker and found that the four-wheeled walker provided improved

mobility, easier tuming and greater overall satisfaction in a sarnple of twenty non-

institutionalized elderly individuals. Likewise, Comely and colleagues (1997) investigated

ambulation variables and user preference on a variety of terrains with a two-wheeled walker

compared to that of a rollator in a mixed sample of healthy adults and elderly. Faster

waiking speeds, longer walking distances, greater comfort and stability as well as better

maneuverability were found with the rollator. Most recently, Comely (1998) reported on a

case of a 68 year old man with a decline in fùnction secondary to renal failure, pancreatitis

and respiratory failure. Although this individual was accustomed to using a standard walker

and had a trial with a two-wheeled walker, he did not expenence ciramatic functional

improvement (e.g. comrnunity ambulation) until he was given a rollator. Reasons cited for

this improvement were reduced upper extremity pain, less physical exertion to advance the

rollator and the presence of a seat, which provided confidence and security.

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1.3.3 Potential Mechanisms of Improvement in Functional Exercise Capacity

for Individuals with COPD with Use of a Wtieeled Walker or Roiiator

Various mechanisms have been postulated to contribute to improvement in

functional capacity with a wheeled walking aid in individuals with COPD (Honeyman et al.,

1996; Campbell, 195 7). Support of the upper extrernities, postural changes and alterations in

gait have al1 been postulated as changes that will reduce metabolic and ventilatory demands

and facilitate the function of the diaphragm and accessory muscles of breathing. These

changes potentially cm reduce exertional dyspnea for a given activity level and therefore

increase fùnctional exercise capacity (O'Donnell. 1998).

Several studies have compared the effect of supported versus non-supported

arms during treadrnill walking and have shown increases in exercise capacity with arm

support (McComell et al., 1991; Parrillo et al., 1991; Von Duvillard & Pivirotto, 1991;

McComell & Clark, 1987; Zeimetl et al., 1985). Pari110 and colleagues (1991) used a

specially designed treadrnill apparatus, which required 5 kilograms of resistive force by hand

compression for the supported am trial. They found that non-supported walking resulted in

significantly greater metabolic, ventilatory and cardiovascular demands. Significant

decreases in oxygen consumption, minute ventilation and heart-rate were observed using

hand-rail support. Several other investigations have reported similar findings and have also

s h o w increases in exercise capacity when handrail support was used (McConnell et al.,

1992 ; Von Duvillard & Pivirotto, 1991; McConnell & Clark, 1987; Zeimetz et al., 1985).

Zeimetz and colleagues (1985) M e r determined that oxygen consumption decreased as

force on the handrails increased and established that depending of the amount of force

exerted during arm support, there was as much as a 30% change in oxygen consumption at a

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given workload when compared to no arm support. None of these investigations used

subjects with COPD. Although the provision of arm support with treadmill wallcing reduces

metabolic and ventilatory demands in healthy individuals, the effect of upper extremity

support on the perception of dyspnea has not been investigated (Breslin, 1992).

Many individuals with COPD sit in a fonvard leaning position supporting their upper

extremities on some fixed object in order to relieve their shortness of breath (Sharp et al.,

1980). Barach (1974) and Sharp and colleagues (1980) studied the effect of several body

positions in individuals with severe COPD and determined that the leaning fonvard position

did result in a reduction in the perception of dyspnea. Delgado and colleagues (1982)

m e r observed that when individuals with COPD exercised on the treadmill in a fonvard

lean position, exercise endurance improved. The postural relief of dyspnea and improvement

in exercise endurance was suggested to be related to the increased effectiveness of the

diaphragm (Delgado et al.. 1982; Sharp et al., 1980; Barach, 1974). Hyperinflation results in

shortening of the diaphragm's muscle fiben (Le. flattening) and a resultant reduciion in the

diaphragm's tension-generating capability (Sharp et al., 1980; Barach, 1974). The forward

lean position induces abdominal compression, which is thought to stretch the diaphragm

upward and improve its tension generating capability (Sharp et al., 1980).

A further effect of leaning forward, particularly when the upper extrernities are

stabilized, may be to increase the effectiveness or efficiency of the accessory muscles of

breathing (Sharp et al., 1980). The accessory muscles of breathing have roles in both the

maintenance of ventilation and the stabilization of the chest wall during unsupported arm

exercise (Breslin, 1992). Although walking is primarily a lower extremity activity,

unsupported arm swing occurs. When the arms are not supported, the accessory muscles are

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required to participate in postural support of the arms and torso and therefore may decrease

their effectiveness in contributing to ventilation (Breslin & Garoutte, 1995; Celli et al.,

1986). This rnay place greater demand on the diaphragm and rnay lead to earlier diaphragm

fatigue (Breslin & Garoutte, 1995; Celli et al., 1986). Support of the arms allows muscles

attached to the shoulder girdle to act more effectively as accessory muscles of breathing

(Banzett et al., 1988).

Although no investigation has evaluated these postulations using a wallcing aid,

several researchers have suggested that the forward lean position that individuals adopt when

using a rollator rnay allow the diaphragm and accessory muscles to optimally contribute to

ventilation (Roomi et al., 1998; Honeyman et al., 1996; Wesmiller & HoMnan, 1994). There

is an inverse association between dyspnea and diaphragm activity and a positive correlation

between dyspnea and accessory muscle recmitment (Breslin et al., 1990). If a shift in the

work of breathing from the accessory muscles to the diaphragm occun, reductions in

dyspnea and minute ventilation and an increase in functional exercise capacity rnay occur.

There are two other potential mechanisms that have received minimal attention in the

literature. First, increased security provided by the rollator rnay decrease fear and anxiety and

consequently rnay reduce shortness of breath and increase functional exercise capacity.

Second, increases in walking distance with use of a wheeled walking aid in individuals with

COPD have been associated with reductions in walking speed (Grant & Capel, 1972). Use of

the rollator rnay promote individuals to reduce their walking speed, thereby, facilitating

pacing and increasing functional exercise performance.

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1.3.4 Summary

Rollatoa are O ften prescnbed for individuals with COPD. However, evidence

regarding their effectiveness is limited and does not allow us to adequately determine the

effect of a rollator on functional exercise capacity in this population. Since the primary

objective of this study was to investigate this issue, it was necessary to determine the best

measure of functional exercise capacity for individuals with COPD. In view of the various

measures of functional exercise capacity available (e.g. two-, six- and twelve-minute walk

tests), the literatwe was reviewed to determine which measwe would be best suited to the

current study. In the next section, waik test measures of functional exercise capacity for

individuals with cardiorespiratory disease are reviewed and the rationale for the selected

measure is provided.

1.4 Walk Test Measures of Functional Exercise Ca~acity in lndividuals with -

Cardiores~iratorv Disease

1.4.1 Definition

Functional walk tests are exercise tests that measure functional capacity; mainly, the

ability to undertake physically demanding activities of daily living (Guyatt et al., 1985a).

They are considered objective measures that provide a means of monitoring response to

treatment and to establishing pmgnosis (Singh et al., 1992). Compared to traditional

laboratory indices of exercise capacity such as cycle, treadmill and step ergometry, walk tests

require less technical expertise and equipment, making them inexpensive and easy to

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adrninister (Mungall & Hainsworth, 1979). More importantly, they employ an activity that

individuals perform on a daily basis, i.e. waiking (Singh et al., 1992).

A variety of waik tests exist including fixed distance tests (e.g. one hundred metre

[Monce & Srnithies, 1984]), velocity determined waik tests (e.g. self-paced walk test [Bassey

et al., 1976]), tirne-based walk tests and shuttle walk tests (e.g. incremental shuale walk test

[Singh et al., 19921. Tirne-based walk tests and the increniental shunle walk test are

commonly used to assess functional exercise capacity in individuals with COPD (Brooks et

al., 1999; Singh et al., 1992). However, because the incrernental shuttle walk test requires

patients to walk at increasing speeds up and down a ten-meter course (Singh et al., 1992), we

did not consider this test feasible to administer with a rollator. Therefore, the following

review of the Iiterature will focus on time-based fiuictional walk tests.

Time-based walk tests include the two-minute walk test, six-minute walk test and

twelve-minute walk test. McGavin and colleagues fint used the twelve-minute walk test in

1 976. These researchen modified Cooper's (1 968) run test to an indoor twelve-minute waik

format for the assessrnent of exercise tolerance in those with chronic bronchitis. Butland and

colleagues (1982) later explored shorter venions of this test (Le. two minutes and six

minutes) in similar populations. These time-based walk tests are ideally conducted in an

enclosed quiet comdor. Individuals are instnicted to walk fiom end to end, covering as

much ground as possible in the allotted time period. Distance walked in the specified tirne

period is recorded.

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1.4.2 Two-Minute Walk Test

The two-minute walk test has been studied in individuals with COPD, congestive

heart failure, children with cystic fibrosis (CF) and the frai1 elderly. Table 2 summarizes

these studies with respect to patient population and results of psychometric testing. In the

assessrnent of studies, interpretation of the strength of correlations was based on a grading

scheme used by Lacasse and colleagues (1997b, 1997~). Specifically, coefficients of

correlations ranging from O to 0.20 were considered negligible; 0.21-0.35, weak; 0.36-0.50,

moderate; and greater than 0.50, strong. This grading scheme was utilized as it has been

previously published and used in similar reviews (Lacasse et al., 199%; Lacasse et al.,

1 997c).

Two studies validated the two-minute walk test as a similar measure of exercise

tolerance as the six-minute waIk test and twelve-minute walk test in individuals with chronic

respiratory disease (Butland et al., 1982; Bernstein et al., 1994). Both Butland and

colleagues (1 982) and Bernstein and colleagues (1 994) found strong correlations with

distance walked in the respective time intervals (i.e. two minutes and six minutes).

Furthemore, Bernstein and colleagues (1994) demonstrated that two-minute walk test

distance was moderately to strongly associated with rneasures of oxygen consurnption (i.e.

some correIations were strong while others were of moderate strength).

One study specifically investigated the effect of encouragement and time of testing on

the reliability of the two-minute walk test (Guyatt et al., 1984). In addition to establishing

the presence of a learning/training effect with repeated testing, Guyatt and colleagues (1984)

found that encouragement improved distance waked while the time of day of testing had no

effect.

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ûnIy one study assessed measurement properties of the two-minute walk test in each

of the pediatric and elderly populations. Upton and colleagues (1988) evaluated the two-

minute walk test as a measure of exercise tolerance in children with CF. They found the test

to be reliable by showing no significant difference in distance walked on repeated testing (Le.

two tests). They also determined that the distance walked was more responsive to treatment

than peak expiratory flow rate in those with near normal respiratory function. In the frai1

elderly, Connelly and colleagues (1996) reported the intra- and inter-rater reliability of the

two-minute walk test to be good to high.

Table 2: Studie Sîudy

Butland et aL (1 982)

Bernstein ez aL (1 994)

Popuiation adults with a varicty of respiratory diseases; predominately chronic airtlow limitation adults with chronic airflow limitation or chronic hem failure or both

chtldren with cystic fibrosis

elderly males with COPD

fiail elderly

VaIiditv: distance walkd correlates strongly with 6MWT (r=0.89) and

I Z M W (r=0.96) distances

Reliabilitv: - trend obsenw.i that simple encouragement irnprovcd distance walked (NS)

time of day of testing had no effect on distance walkcd - within subject vanabilit-y similar with and without encouragement -distance wilked improv&I on fim 2 walks cornparcd to lasi4 (pd.000 1 ) Res~onsfveness: -1es.s rcsponsive (0.90) than 6MWT (0.74) w.r.t ratio of within person standard deviation to ncaunent effect Reliabilitv:

no significmt difference on repeated testing; mean coefficient of variation 2.6% R e ~ ~ ~ n ~ i ~ e n e î s : -more responsive io in-patient treatment than PEFR Validitv: - using nvo minute intervals of the 1 ZM WT, distance walkcd in nvo minutes correlated mongly with distance walked in 6 ( ~ 0 . 9 5 ) and 12 minutes ( ~ û . 9 4 )

distance walked correlated strongly with V02/kg (r=O.55); moderately with V O r m (r=0.45) and negligibly with spiromeûic values (r-0.W. 13) Res~onsivencss: -change in distance walked strongly correlated with changes in VO& (r4.53) and V O z m 1s.53)

-

Reliabilitv: - inter-rater, ICC: 0.93-0.95 -intra-rater. ICC: 0.82-0.89

6MWT 6-mïnutc wlk test; lZMWT 12-minute wakk test; COPD chronic obsüuctivt pulrnonary discase; ICC intraclas conrl~tion coetficicnt; NS not significan~ PEFR p d c expintory flow ntc; VO* oxygcn consumption; VO~max r r n x i d oxygm consuniption; w.r.1 with mspcct to

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1.4.3 Six-Minute Walk Test

The six-minute walk test has been studied arnong several different populations

including individuals with COPD, individuals with heart failure, individuals with

pacemakers, individuals with penpheral arterial disease, surgical patients and pediatric

patients. Tables 3-5 summarize these studies with respect to patient population and results of

psychometric testing. The majority of studies have focused on validating the test by

correlating distance walked to several other reference critena.

In individuals with COPD, several studies have examined validity of the six-minute

walk test by correlating distance waked to maximal oxygen consumption (V02ma.u),

pulmonary function tests (PFT), and rneasures of function and dyspnea. Distance walked has

been found to strongly correlate with V02rnax and workload maximum measured during

cycle ergometry (Bernstein et al., 1994; Wijkstra et al., 1994; Guyatt et al., 1985a; Guyatt et

al., 1985b;) and to moderately to strongly correlate with measures of fùnction (Guyatt et al.,

1985a; Guyatt et al., 1985b). Correlation with spirometry lacks agreement with some studies

finding strong relationships (Wijkstra et al., 1994; Mak et al. 1993) and others weak

(Bernstein et al., 1994). Correlation to measures of dyspnea have not yielded consistent

results (Wijkstra et al., 1994; Mak et al. 1993; Guyatt et al., 1985a; Guyatt et al., 1985b) and

correlation with the Chronic Respiratory Disease Questionnaire (CRQ) has been reported to

be weak (Wijkstra et al., 1994).

In individuals with heart failure, strong correlations between six-minute walk test

distance and VOzmax were observed by severai researchen (Roul et al., 1998; Cahalin et al.,

1996; Riley et al., 1992; Lipkin et al., 1986; Guyatt et al., 1985a; Guyatt et al., 1985b) and

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moderate to strong associations with the New York Heart Association m] functional

classifications, oxygen cost diagram, Specific Activity Scale, Chronic Heart Failure

Questionnaire and the Rand instrument (O'Keeffe et al., 1998; Guyatt et al., 1 %sa; Guyatt et

al., 1985b). Furthemore, several studies have shown that six-minute walk test distance c m

discriminate between NYHA classification levels (Peeten & Mets, 1996; Riley et al., 1992;

Lipkin et al., 1986). Results of other studies in the same population have shown that distance

walked on the six-minute walk test [5300 meters] c m identiQ those with increased

likelihood of death or hospitalization within a time-frame ranging from three months to one

year (Milligan et al., 1997; Cahalin et al., 1996; Bittner et al., 1993). One study found no

prognostic value for survival of the six-minute walk test in individuals with advanced heart

failure (Lucas et al. 1999).

In individuals with pacemakers, distance waked has been determined to be

significantly related to oxygen cost, as measured by oxygen cost diagrams (Rozkovec et al.,

1 W ) , and exercise ergometry performance (Langenfeld et al., 1990). Other investigations

have shown that distance walked in six minutes is able to discriminate between pace modes

(Le. fixed rate or optimal response) and rates (Provenier & Jordaens, 1994; Rozkovec et al.,

1989).

In the context of pre-operative assessment, Holden and colleagues (1992) and

Szekely and colleagues (1997) showed that distance walked was predictive in regards to the

probability of successful surgical outcornes in patients undergoing pulmonary resection and

volume reduction surgery respectively. Another study (Kadikar et al., 1997) determined that

distances walked of less than 400 and 300 meters were usehl indicators of when to list and

prioritize patients for lung transplantation respectively.

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Studies of reliability have concentrated on three main areas; specifically, the effect of

encouragement (in individuals with chronic heari and lung disease), senal testing (in

individuals with chronic lung disease, heart failure, pacemakers and peripheral artenal

occlusive disease) and time of testing (in individuals with chronic heart and lung disease).

Guyatt and colleagues (1984) found that while time of day of testing had no significant effect

on distance walked, differential encouragement produced variable results. Investigations of

repeated testing have s h o w generally comparable findings with total distance walked being

variable on the initial two walks and establishing consistency on the third (Guyaa et al.,

l985a; Guyatt et al., 198%; Guyatt et al., 1984; Langenfeld et al., 1990; Riley et al., 1997).

One study was specifically devoted to interpretability of the six-minute walk test.

Redelmeier and colleagues (1997) evaluated individuals with COPD and established that a

minimal change in walking distance of fifty-four meters is clinically important in that it

translates into a noticeable change in functional statu. This information is usefil for

examining the results of clinical trials. For example, Redelmeier and colleagues (1997)

reviewed the literature on the use of walk tests for measuring the effectiveness of treatments

for patients with COPD and found that 68% of the studies finding statistically significant

results reported differences in six-minute walking distance that were less than 54 meten.

Similarly, a meta-analysis revealed that the best estimate of the effect of respiratory

rehabilitation for individuals with COPD on distance walked in six minutes was 56 meters,

just two meters greater than the minimal clinically important difference (Lacasse et al.,

1996). Additionaily, recently established normal values and reference equations for the six-

minute waik test will potentially allow clinicians to detemine percent predicted values

(Troosters et al., 1999; Enright & Sherrill, 1998).

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Finally, studies of responsiveness have shown that improvement in six-minute walk

test distance is related to diminished breathlessness in pacemaker patients (Rozkovec et al.,

1989), improvement in quality of life for elderly patients with heart failure (O'Keeffe et al.,

1998) and that changes in distance walked correlate with changes in V02max in individuals

with COPD (Bernstein et al., 1994).

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Table 3: Studies of Psychometric Properties of the Six-Minute Walk Test in Patients with Chronic Obstructive Pulmonary D

Sîudy Bntfand et a& (1 982)

Guyalt et aL (1 984)

Guyan et aL (1 985b)'

Guyan et a& f I 9850).

Mak et aL(1993)

Wjkstra et aL ( 1 994)

Bernstein a aL(1994)

Popuiation adults with stabIe chronic respiratory disability adults with chronic airflow limitation or chronic heart failure or both

adults with chronic hem failure or chronic lung discase

- -

dul t s with chronic hem failure or chronic lune disease

du l t s with COPD or severe asthma

adults with COPD

elderly males with moderate COPD

Validitv: distance walked correlated strongly with 1 2MWï (r=0.96) and îMWT (r=0.89)

ReliabiliW: simple encouragement improved distance waIked (mean 30.5m, pc0.02) tirne of day of testing had no effect on distance walked within subject variability similar with and without encouragement w.r.t. test-retest (first wo walks compareci to 1s t four), distance walked

improved (p<0.000 1 ) Res~onsiveness:

reported to be more responsive (0.74) than the ZMWT (0.90) w.r.t. ratio of within person SD to treatment effect Validitv:

distance walked strongly conelated with cycle ergorneter test results (r=0.58, p<0.001) and negatively and modentely correlated with funcrional status as determincd by NYHA criteria (r= -0.45, p=0.06) and the SAS (r= -0.47, p=0.001) Relhbilitv: distance walked plateaued dunng walks 3-6 (p<O.ûû 1) within person SD of subjcct's mean distance walked was ~ 6 %

Validitv: distance walked stmngly correlated with cycle crgomeny test results (r=0.58,

p<O.OOI ) and moderately to strong with four functional status questionnaires [Rand Instrument, BDI. Thc Oxygen Cost Diagnm and the SAS], (r=0.47-0.59, p<o.Oo 1 ) Relia biliw:

ICC: 0.9 1-0.92 within- person SD was 22.52m with a coefticient of variation of 0.05 for walks

3-6 (versus within-person SD 29.8. coefticient of variation 0.07 for al1 6 walks) Validitv:

distance walked significantly (p4.001) and strongly correlated with Dtco (r=0.68), PEF @=OS), FEV, (r=0.53); negatively and strongly correlated with breathlessness rating on the MRC scale (-0.52); modentely correlated with FVC (r=0.48); negatively and weakly correlated with pcrceived breathlessness as measured by VAS (r= -0.35) and RPE measured by the Borg scale (r= -0.30); and did not correlate with Sa02 Validitv:

dinance walked mongly correlatcd with Wmax as assesseci by bicycle ergornetry (r=0.8 1, p<O.Ot), spirometric vdues and MIP (r=0.50-0.58) and DLco (~0 .62 ) ; negatively and moderately correlated with dyspnca at rest measured by the Borg scale (r= 4.41, p<0.01); and negligibly -weakly (F-0.03 to -0.25) with quality of life as rneasured by the CRQ (Fatigue. Emotion and Mastery domains) Validitv:

distance walked strongly correlated to V02 (r=0.5 1 ) and VO&g ( ~ 0 . 6 7 ) as assesseci by bicycle ergometry and distance wdked in 2 minutes ( ~ 0 . 9 5 ) and 12 minutes (r=0.97) but negligibly to weakly correlated with spirometry values (r=O .OS-û.X) Res~onsiveness:

changes in distance walked stronply correlated to changes in VGrnax (r=0.64)

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nued) Po~uhtion

elderiy subjects with COPD

volume reduction surgery patients secondary to severe COPD

Measurement Properties Validitv:

distance walked significantly and strongly conrlated with Guyatt dyspnea score ( ~ 0 . 6 5 ; m.01) ReIiabilitv:

mean distance difference on repeated tests = 0.65rn (p-0.94) coefficient of repeatability = 63.0

Validiîv: presperative distance walked weakly to rnoderately correlated with lcngth of

hospitalization (r=0.32-0.40, pcO.05) presperative distance walked of eûûm specific (U%, p<O.i)04) in death

adults with stable COPD

Validiîv: distance wa1ked strongly correlated with patients' rating of heir walking ability

relative to othcr patients (r=0.59,95%CI: 0.54-0.63) Intemretabilitv:

distance walked ne& to differ by 54m (95%C1:37-71m) for the average patient to stop rating thernselves as "about the same" and to start nting themselves as "a littlc bit better" or "a linle bit worsc" in rating their walking ability relative to

'dcnota mixed w . Dyspnca Index; CI confidcnc; i n m a l ; COPD chronic obsmictivc pulmonary dix=; CRQ h n i c Rcspintory Discase Qucstionnairt; h c o diffusion capacity of carbon rnonoxide; FEV, forced cxpinmry volume in 1 second; N C forccd vital capacity; [CC inaclass correlation cocfficicnt; rn mettr, MIP maximum inspintory pressure; MRC Medical Rescarch Council; NYiiA New York Heart Association: N S not signiticant; PEF peak cxpiratory flow; RPE rating of pcrccivcd cxtrtion; SaO? Ytnal oxygm saturation; SAS Spccific Activity Scale; S D scandard deviation; VAS viswl analogue scalc; V O z m maximal oxygm consumption; W m u rnamul work capacity; w.r . t *ith respect to

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Table 4: Stuc Siudy

Lipkin et aL (1 986)

Riley n aL(1992)

Cahalin et aL(1996)

Peeters and Mm (1 996)

Müiigan n aL(I997)

woo el aL(l997)

5 of Psychometric P Population

adu1t.s with stable chronic hem failure (NYHA CI= 11-111)

adults with chronic heart faiIure (NYHA class II-IV)

adults with CHF (SOLVD registry)

adults with chronic hem faihrc undergoing cardiac transplant evaluation

elderly subjects with chronic hem failure (NYHA class II-III)

phase I cardiac rehabilitation inpatients with leR ventricular dysfunction adults with advanced hem failure (NYHA class r r 1 4 v )

perties of the Six-Minute Wak Test in Patients with Heart Failure Mesisurement Properties

Validitv: distance waIked related t0V0~rna.x curvilinearIy (large variance in chose with

low versus high V02rnax) ail patients considerd walk test more representative of daily physical activity

than treadmill test able to distinguish b/w normals, NYHA class 11 and class I I I heart failure

patients ( ~ 0 . 0 0 3 ) based on distance walked Validitv:

distance walkeâ smngly correlated with V02 max measured during treadmill ergometry (r=0.88, p<0.0001) and peak V02 measured during thc walk test (r=0.90; ~ 0 . 0 0 0 1 )

able to distinguish b/w NYHA class II, I I I & IV patients based on distance waIked Reliabilitv:

distance walked increased from test 1 to test 2, but no significant difference was seen from test 2 to test 3 ValidiW:

patients in the lowest performance levels (distance walked <300m) had a significantly greater chance of dying (10.23% vs. 2.99%, p=O.O 1 ), of being hospitalized in general (40.91% vs. 19.90%. p=0.002) and of being hospitalized for hem failure (22.16% vs. 1.99OA. pO.001 ) within subsequent year

compared with those who walked at least 450rn, patients who walkcd less than 300m had a 3.7- fold risk of dying (95OhCI: 1.34-9.33) and those who walked between 300-3749m had a 1.78-fold risk (9S%CI: 1 .O!?-7.1 1 ) within subsequent Yeu Intemretabilitv: each dccrement in distance walkcd of IZOrn rcsultcd in a 160% increase in

hospitalization for CHF during the one year follow-up pcriod

Validitv: distance walked smngly correlated with VO?mau (r=0.64, i=0.41. p O . O O O 1 ) in a multivariatc analysis of patient chancteristics, resting hemodynamics and

6MWT distance, distance walked was the strongest predictor of VQmax distance walkeâ c300rn prcdictcd an increased likelihood of death or pre-

transplant hospital admission within 6 months (40% vs. 12%. p=0.04) but did not predict long term overall or event-free survival Reliabilitv:

ICC:O.96 Validitv:

significant difference in distance walked between NYHA class 11 and I I I patients and between controls and between contruls and class III patients (p<O.OO 1 ); difference betwecn controls and class II patients NS Validity:

patients who survived greater than 3 months walked significantly further than those who survived less than 3 montfis (3.56 vs. 2.35, p=û.003) according to the following scale: l =non-ambulatory; 2= 10-1 00 ft; 3= 10 1 -500 ft; 4=50 1 - 1000 ft; 5=1001-2000 ff +2000 + ft Validitv:

distance walked not significantly associated with hem rate variabiIity (non- invasive masure of autonomic tone)

distance walked related (value not given) to I year rnonality ( ~ 0 . 0 3 ) but not to risk of sudden de&

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ued) Popuiation

adults with hem failure

frail e[derly subjects with h e m failure

adults with chronic congestive heart failure adults with advanced hem failure

distance walked snongly correlated to VO,max in patients who walked less than 300m (r-0.65, h . 4 2 , p=O.O 1 )

no sîgnificant difference in distance walked between patients who died or were hospitalized for heart faiIure and thosc who s u ~ i v e d event-free - using ROC curves and survival curve analysis, subjects walking less than 300m tendcd to have wone outcomes Reliabilitv:

ICC:0.82 Validitv:

mong bascline correlation between distanceci waiked and total CHQ score: F - 0.79; with dyspnea dimension of CHQ: r= -0.58 ReliabilItv: [CC = 0.91

Res~onsiveness: responsiveness coefficient 1.73 effect size for detecting subjective heart failure deterioration (2.13) greater than

for detecting improvement (0.85) change in distance walked strongf y correlated with change in total CHQ score

(r=0.70), dyspnea dimension (r=0.60), fatigue dimension (r=0.58) and global nting of change (r=0.78); modentcly correlated with cmotion dimension of CHQ (r=0.47) Reliabilitv:

results (ie. distance walked) of tests performed the same day 30 minutcs rtpart are quivalent to results of tests performed on t consccutive days Vat iditv:

monç correlatian (r=0.57) with peak V 0 2 whcn al1 subjects includcd; wcak correlation ( d . 2 8 ) when only subjects with peak V 0 2 between 10-20 mLkg pcr minute includd

6MWT distance did not predict survival congestive

-

-

Table 4 (contin Study

Roui et all (1 998)

O ' Keefle a aL, (1 998)

Oposich a aL (1 998)

hem

m

-

--

-

tt fcct; CHQ

Lucas et a&, ,1999)

:

bMWT 6-minute Chmnic I

wdk test; biw betwm; C ICC correlation çoctlïcicnt; m meters; NYHA New York Hcart Association; NS not stgnificuit; Studies of Leil Vcnmcular Dysfunction; V02m;i.t miml oxygcn consumption

ROC SOLVD

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Table Study

adults with pacemakers

Langen fefd et aL (1 990)

adults with pacemakers

Provenier & Jordaens (1 994)

adults with pacemakers

Cahaiin et aL (1 995)

adults with end- stage lung disease (msplant candidates)

Kadikar et oL(1997)

Niron et al. (1 996)

adults with end- stage lung disease

children with end- stage cardiac or pulmonary diserise (awaiting

Holden et aL(1992)

~Montgorncry & Gardner (1 998)

Harada a al,( 1999)

transplantation) pulmonary rcsection patients secondary to bronchogenic carcinoma

adults with intermittent claudication secondary to peripheral artenal disease older adults

:ric Properties of the Sir-Minute Walk Test Measurement Prmerties

Validitv: distance walked directly related to con (ie. as per O2 diagram) ( ~ 0 . 0 5 ) significant difference in distance walked b/w pacing rates (50, 70 and 90 bpm)

Res~ansiveaess: improvement in breathlessness over preceding 2 weeks signif~cantiy

associated with an increase in waIking distance Validitv:

distance walked strongly correlated with cycle ergorneuy ( ~ 0 . 7 4 ) al1 patients stated walk test replicated daily physical activity more accuntely thm

cycle ergornetry ReIiabiIitv:

no simificant difference in distance walked found between reucated walks Validitv:

distance walked significantly greater in the W I R set pacemaker than in the f ~ ~ t d VVI) of 60bpm (21.91~1; 9596CI: 3.540.3m) and in WI 85 than in WI 60 ( 14.71~1; 95%CI 0.6-28.9m) Validitv:

distance walked strong predictor of V02max (r=0.73. ?=0.54, p<O.OOOI) no significant diffcrence found betwetn esrimateci and observed V0,rna~ using

prediction equation based on 6M WT distance Reliabilitv:

ICC reportai to be 0.99; however, no indication was given in methods that reliability was tested. Validitv:

findings suggestive of predictive validity distance walked 400m prcdictive of dcath with scnsitivity: 0.80. specrficity:

0.49, PPV: 0.27 and NPV: 0.9 1 distance walked<3ûûm prcdictive of death with sensitivity: 0.52, specificity:

0.80, PPV : 0.38 and NPV: 0.88 Validitv:

distance walked corrclated with V02mac ( d . 7 0 , pc0.05) and physical work capacity (r=0.64, pe0.05) but was not significmtly related to indexes of pulmonrüy function ( r d . 15-0.26)

Validitv: those who had successful surgical outcomes walked further than those who died

within 90 days of surgery distances of greater than IO00 feet predicttve of successful surgical outcorne

(long-term survival greater han 90 days) [sensitivity: 100%; PPV: 85%; NNV:

distance wdked strongly correlated with the AnkIeBrachial Index (r=0.55, p<O.OO i ) and modentely conelated with V02max ( ~ 0 . 3 7 , p=O.O 1 ) Reliabilitv:

[CC:0.94, coefficient of variation 10.4% for distance walked [CC: 0.90. coefficient of variation 1 1.7% for numbcr of seps

Validitv: distance walked significantly greater for active vs. inactive subjects ( ~ 0 . 0 0 0 1 ) distance walked correlated strongly with lower body strength (Le. chair stands)

[r=O.6fl, standing balance (r=0.52), self-reported physical functioning [SF-36 Health Survey] ( ~ 0 . 5 5 ) and gait speed (r4.73); moderately with general halth perceptions (r=0.39) and ncgligibly with body mass index ( ~ 0 . 0 7 ) . Reliabilitv:

one week test-retest reliability was 0.95 iL

6MWT 6-minute walk test; bpm k t s per minute; biw bctwcen; CI confidence NPV negahvc prcdictivc value; 0: oxygcn; PPV positive prcdictivc value; rrsponsc; VViR optimal rate rtsponsc

3

.,

-

9

m nrtcrs; fixed rate

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1.4.4 Twelve-Miuute Walk Test

Adults with respiratory diseases were the only patient group with published Iiterature

on the twelve-minute walk test. Studies examining the psychometric properties of the

twelve-minute walk test are summarized in table 6.

Several studies have correlated distance walked in twelve minutes with measures of

functional status and VOzmax or workload maximum with generally consistent findings. For

instance, several investigators (Larson et al., 19%; O'Reilly et al., 1982; McGavin et al.,

1978) have found moderate to strong correlations with subjective assessments of function,

while othen (Bernstein et al., 1994; Swinbum et al., 1985; Alison & Anderson, 1981;

McGavin et al., 1976) have found strong correlations with measurements (Le. VOz mau and

workload maximum) taken during exercise ergometry. As noted for the six-minute walk test,

studies evaluating the relationship between distance walked in twelve minutes and measures

of pulmonary function have produced variable results. For exarnple, correlations between

twelve-minute walk test distance and FEVl have ranged fiom not significant (Mungall &

Hainsworth, 1979; McGavin et al., 1 W6), to negligible (Gerardi et al., 1996; Swinbum et al.,

1985; O'Reilly et al., 1982), to moderate (Larson et al., 1996; McGavin et al., 1978), to

strong (Dekhuyzen et al., 1986; Alison & Anderson, 1981). One study (Gerardi et al., 1996)

found that twelve-minute walk test performance (i.e. distance walked) after out-patient

pulmonary rehabilitation was the most influential predictor of mortality for individuals with

severe COPD when compared to FEV,, arterial blood gases, weight, quality of life scores,

CO-morbidity and oxygen and medication requirements.

The only study to evaluate the twelve-minute walk test in the context of pre-operative

assesment was by Bagg (1984). The results of this investigation suggested that the test was

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not discriminative in regards to the risk of occurrence of post-operative complications in

individuals undergoing pulrnonary resection.

Studies of reliability have s h o w generally similar findings with distance walked

being variable on the initial two walks and establishing consistency on the third (Lanon et

al., 1996; Swinbum et al., 1985; Mungall & Hainsworth, 1979; McGavin et al., 1976).

Studies of responsiveness have found the twelve-minute walk test to be sensitive to

changes in exercise capacity (Bernstein et al., 1994; Cockcroft et al., 1981) and to strongiy

correlate with changes in assessments of breathlessness (O'Reilly et al., 1982) but that

changes in distance walked were not related to long-term survival in individuals with COPD

(Gerardi et al., 1996).

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Rlison & Anderson (1 98 1)

Swinburn et aL(1985)

male adults with chronic bronchitis

adults with respiratory disease (airway obstruction or infiltrative diseases ) adult males with chronic bronchitis

d u i t males with COPD

adults with COPD

adult males with COPD

adults with chronic respiratory disability lung resection patients second- to carcinoma of the bronchus

adults with severe COPD

! f ies of the Twelve Minute Walk Test Merisurement Pro~erües

distance walked significantly correlated with VOlrnax (r=O.jt. p<0.01), VE (r=0.53, p<O.O 1, FVC (r=O.4 1, ~ 0 . 0 5 ) ; NS with FEV, (r=0.28, p>0.05) Reliabilitv:

reported to be reliable if pcrformed twice; howcver, data used to support this . .

conclusion is not clearly pksented Validitv:

distance walked significantly ( ~ 0 . 0 1) and strongly correlated with FVC (r=0.52-0.64), oxygen-cost diûgram (r=0.60-0.68) and RPE (r= -0.39 to -0.74) in both diseases; strongly correlated with DLc0 (r=0.63) and modentely correlated with FEV, (~0.44) in those with infiltrative disease

Validitv: distance walked mongly correlated with DLco (r=0.67; p<O.OI); invenely and

strongly correlated with ventilatory response to an increase in oxygen uptake (r=0.77; ~ ~ 0 . 0 1 ) ; NS with FVC, FEV, or TLC Relinbilitv:

distance walked on test 3 significantly ( ~ 0 . 0 5 ) bener than on tests 1 and 3; no signifiant change aAer test 3

coefficient of variation +4Z% aAcr test 3 Res~onsiveness:

the most sensitive index of change in functional exercise tolerance aAer rchabili cation whcn cornpareci to spiromecry. treadmill ergomctry and subjective interviews

distance walked strongly correlated with Wma. (r=0.68, p-4.001). FEV, ( ~ û . 6 2 , p<0.001) and VC (r=0.65, p<O.OOI)

VOzmax mcasured during IZMWT did not differ significantly from V02max measured on the bicycle erpomcter Validitv:

distance walked modentely-strongly correlated with asscssrnents of breathlessness (~0.50-0.70, pcO.001); but did not correlate with spimmetry Reliability:

mean variation of 3.1 % when perforrned twicc on same day; 9.1 % when performed 2 weeks apan Res~onsiven ess:

changes in distance walked strongly correlated with changes in assessmcnts of breathlessness (~0.64-0.90) and with DLc0 (~0.68, pcO.05) Validitv:

Iargest variance (29.6 m) when compared to the 2iMW (23.4 rn) and 6MWT (26.0 m) distances Validitv:

no significant difkence ( ~ 0 . 0 5 ) in distance walked benveen patients who did and did not suffer pst-operative complications

while PFT provided significant separation b/w groups, no further discriminating power was abserveci with distance walked Validitv:

!inance waiked strongly correlateci aith p e r f o m c e on cycle ergometry (r=Q.S 1, ~ 0 . 0 1 ) a@ nep ergometry (?=OS?. pc0.0 1 ) but not with FEV, (?=O. 13) or W C (-0.1 7) Reiiabilitv:

significant (peO.0 1 ) increase in distance walked biw tests I & 4; however, incrernents blw successive attempts tended ta decrease

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Table 6 (continu Study

Dekhuyzcn et aL(l986).

Bernstein eî aL(1994)

Gerardi et a l (1 996)

Population out-patient adults with COPD

elderly mdes with modente COPD

predominantly (87%) adults with severe COPD

adults with moderate-severe COPD

Measurernent Pm perdes Validitv:

distance walked strongly conelated with FEVt [ml] (r=0.62; p=O.ûûI); moderately correlated with IVC [% predicted] ( ~ 0 . 4 9 , p=0.001), FEV, [% predicted] (r=0.49, pQ.00 1 ). PaOS (r=O.U, p=O.O 1); and weakly correlated with DLco (r=0.34. p=0.05) Validitv: + distance walked correlated strongly to VOTfkg ( ~ 0 . 6 5 ) and moderately to V0: (r0.49) as ysessed by bicycle ergohetry; cor&atd negligibly with spirometry values (r=O. 12-0.26)

distance walked stmngly correlated with that in 2 & 6 minutes (r=0.94-0.97) Res~onsiveness:

changes in V02max more closely related to changes in IZMWT distance (r=0.72) than to changes in shoner duntion walk test distances (r=0.53-0.63) Validitv:

pre-rehabilitation distance walked negligibly correlated with FEVl (r=O. 19; p=0.03) and weakiy correlatcd with total CRQ score ( ~ 0 . 2 3 ; p-0.0 1 )

post-outpatient pulmonary rehabilitation distance walked most significant variable related to prognosis compared to FEV,, ABG, weight, CRQ score, co- morbidity, oxygen requirements and medication requirements

patients with post rehabilitation distance walked ~750m had 68% 3- year survival; those with distances walked >750m had 92% 3-yeac survival Res~onsiveness:

17% change in distance walked between pre- and post-outpatient pu lmonq rehabilitation: however. change not relata to long term sukival

-

Validity: walk distance correlated strongly with MIP ( ~ 0 . 5 2 ) ; modentcly with FEV,

(% preâicted] ( ~ 0 . 4 0 ) ; rnodentely and ncgativcly with the total SIP (F -0.37). thc Physical Dimension of the SIP (r= -0.45), and exercisc related breathlessness as measured by ATS-DLD Breaihlessness Scale ( r= -0.49) Reliability:

distancc walkcd increascd over first 3 tests (pcO.01); tcst-retcst reliability:

.L ad

bl& prises; ATS-DL0 Arncncan Thoncic Society. Division of Lung Disases, COPD chmnic obstmctive pulrnonq diseasc; h c o diffusion capacity of carbon rnonoxidc; FEV, forceci expintory volume in I second; FVC forccd vital capacity; [VC inspintory vital capacity; rn rncters; MIP mximurn expintory pressure; NS not significant; PaO? partial prrssurc of arvnal oxygcn; PFT pulmonary function testing; RPE nting of perccivcd excruon; SIP Sickness Impact Profile; TLC total lung capacity; VE; minute vcntilauon; V 0 2 oxygcn consumption;V02m;t m t m l oxygcn consumption; Wrmx maximal work capacity

1 r0.98 for tests 3 8r 4 1 mill; ?MW' 2-minuu walk tesc 6MWT 6-minute walk test; I2MWT 12- rninutc walk tesf b/w bcwcen; ABG arrend

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1.4.5 Factors Affecting Performance

Several variables have been identified in the literature as potentially influencing

distance walked during a time-based walk test. Fint, the use of differential encouragement

can affect test results and therefore necessitates that the use of encouragement with walk test

administration be standardized with respect to type and timing (Guyatt et al., 1984). in the

studies reviewed, standardized encouragement consisted of specific statements given by the

test adrninistrator (e.g. "keep up the good work" and "you're doing well") every 30 to 60

seconds (Guyaa et al., 1984). The magnitude of the effect of encouragement on distance

walked found by Guyatt and colleagues (1984) [Le. 30.5 meten] was similar to that reported

in studies claiming to show beneficial effects of treatment interventions (Guyatt et al., 1984)

and approached the minimal clinically important difference f o n d for the six-minute walk

test by Redeimeier and colleagues (1997). Second, training and leaming effects with

repeated testing have been identified in several studies (Lanon et al., 1996; Riley et al.,

1992; Sin& et al., 1992; Upton et al., 1988; Guyatt et al., 1985a; Guyatt et al., 1985b;

Swinbum et al., 1985; Guyatt et al., 1984; Butland et al, 1982; Mungall & Hainsworth, 1979;

McGavin et al., 1976). For instance, one study (Guyatt et al., l985b) showed that six-minute

walk test distance could improve sixty meters afier three repeated six-minute walk tests in

individuals with COPD. These effects potentially could be misinterpreted as a positive

treatment effect or improvement in fûnctional statu, thereby illustrating the necessity of two

practice walks before performance is measured (Bittner, 1997). Third, placement of the

tester during the walk test (Le. standing still, walking behind patient, or waiking beside

patient) may affect performance. Although no study was located that investigated this factor

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(Le. pacing), it would seem appropriate that the tester either stand still at one end of the

comdor or walk behind the patient to avoid pacing. Finally, numerous studies have

recognized that patients' feelings and mood c m affect performance (Bernstein et al., 1994;

Mak et al, 1993; Knox et al., 1988; McGavin et al, 1976).

1 A.6 Summary

The measurement of functional exercise capacity has become an integral component

of evaluating the impact of an intervention and detemining prognosis in those with

cardiorespiratory disease. The two-, six-, and twelve-minute walk tests are cornmonly used

for the measurement of functional exercise capacity in these individuals. Table 7

summarizes the evidence for the psychometric properties of two-, six- and twelve-minute

walk tests.

Table 7: Summary of the Evidence for the Psychometric Properties of the Two-, Six- and Twelve-Minute Walk Tests

Items in prcntheses denotes population in which psychomctnc pmperty was cxamined; + dcnotcs cvidcncc to support; - denotes cvidmce to rcfutc; O denotes no cvidencc; CHF congestive hem failurc; CF cystic tibmsis; COPD chmnic obsmctive pulmonary disase' ESLD end swgc lung discase; PAD penpheral artcrial discase

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In addition to considering the psychometric properties of these tests, thought must

also be given to feasibility, ease of administration and patient tolerance when recommending

a specific test for clinical or research purposes. When comparing timed-based walk tests, the

six-minute walk test presents with a number of advantages. The six-minute walk test is

better tolerated by individuals with respiratory disease than the twelve-minute walk test

(Butland et al., 1982). It is also more reliable and responsive than the two-minute walk test

(Guyatt et al., 1984) and more reflective of the requirements of activities of daily living.

Given these advantages and supported measurement properties for individuals with COPD,

the six-minute walk test was chosen for the current study.

1.5 Research Questions and Hv~otheses -

Rollators are ofien prescribed for individuals with COPD in an effort to improve their

hnctional exercise capacity and quality of life. The Assistive Devices Pmgrarn of the

Ontario Ministry of Health provides financial assistance for the purchase of equipment

essential for mobility and independent living and currently fùnds up to seventy-five percent

of the cost of these rollators; the remainder being funded by the patient. Given the costs to

the patient and the health care system, it is important that the more widespread usage of

rollaton be preceded by evidence of their effectiveness. The current evidence does not allow

us to adequately determine the effect of a rollator on bct ional exercise capacity in

individuals with COPD, nor does it allow us to predict which individuals with COPD will

benefit most frorn using a rollator. Finally, the available literahire does not provide

significant insight into the specific mechanisms that may be responsible for change in

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hctional exercise capacity with use of a rollator. As such, this study was conducted to

answer the following research questions:

1) What is the short-term eflect of a rollator on funciional pxercise capacity in individuals with CWD?

2) Which individuals with COPD will benefii most from using a rollator?

3) What are the underlying mechanisms that may contribute to change in funetional mercise capacity with use of a rollator?

The research hypotheses for this study are:

1) The use of a rollator improves functional erercise capaciy in individ~ials with COPD us determined by an improvement in distance walked andor a reduction in dvspnea during the si.-minute walk test.

2) Individuals who are most disabled (based on distance walked) will benefit most fronr using a rollator.

3) Change in breathing pattern is the mechanism responsible for improvenlent in funciional exercise capacip with use of a rollator. ntere will be no ussociated change in gait variables.

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Chapter 2: Methods

2.1 Subiects -

2.1.1 Sampling and Recruitment

A sample size estimation using a two-tailed test with a type 1 emor of 0.05 and power

of 90% determined that a clinically significant difference in six-minute waik test distance

(i.e. 54 meters, Redeheier et al., 1997) would be detected with a minimum of 16 subjects.

This sample size calculation assurned a standard deviation of 86 meten based on variability

observed in previous studies fiom West Park Hospital (Goldstein et al., 1994). However, to

allow for the potential of using multiple linear regression with at least three variables, a

sample size of 40 was sought. This estimation was based on the method described by

Norman and Streiner (1999) who recomrnended that the sample size be 5 to 10 times the

number of variables included in the regression equation.

Subjects were recruited from the respiratory rehabilitation prograrns (Le. in-patient

and out-patient) at West Park Hospital (Toronto, Ontario, Canada). Subject recruitment

occurred between October 1999 and Iuly 2000.

2.1.2 Inclusion and Exclusion Criteria

Subjects were considered eligible for the study if they had a medical diagnosis of

COPD, were between 55 and 85 years of age and were unaccustorned to the use of a rollator.

Furthemore, they had to be clinically stable with no evidence of acute exacerbation.

Exclusion criteria included the presence of CO-existing conditions that may have limited

exercise tolerance or ambulation (eg. angina, uncontrolled cardiovascular disease,

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musculoskeletal problems). Subjects who were not able to communicate in English or who

were unable to waik unaided were also excluded. Subjects who were partaking in a post-

operative respiratory rehabilitation program (Le. post lung volume reduction surgery,

bullectomy or transplant) were not considered eligible for the study. A screening form was

used to determine eligibility (Appendix 1).

2.2 Studv Desim -

2.2.1 Protocol

Al1 research procedures were approved by the Human Subjects Review Committee at

the University of Toronto (protocol #3289) and the Clinical Evaluation and Research Unit

and the Medical Quality Improvement Committee (Research) at West Park Hospital. The

study was hlly explained to subjects and written informed consent was obtained fiom al1

subjects (Appendix 2).

A randomized cross-over design, using the six-minute walk test as the primary

outcome measure, was used for this study. The six-minute walk tests were camed out as in

Honeyrnan and colleagues (1996). Each subject was studied at the same time of day on two

separate days in the same calendar week. On each study day, two six-minute wak tests were

performed with a minimum of a one-hour rest in between. One walk test was performed

unaided and the other done using a rollator (Opal Legacy, Therapist's Choice Medical

Supplies, Toronto, Ontario) with the order of the test randomized, using a random number

table, on the first day and reversed on the second day.

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The study was conducted over 60 meters of a 3.4 meter wide enclosed comdor at

West Park Hospital. Pylons were placed at either end of the course. We chose the longest and

widest course available to minimize the effects of tuming. Every attempt was made to

perform testing under quiet conditions with a minimum of distractions and comdor traffic.

Al1 subjects perfonned at least two practice walks before data collection in order to control

for learning and practice effects (Bittner, 1997). Standardized instructions were provided to

subjects and no encouragement was offered during the tests. Subjects were insmicted to: 1)

walk From end to end, covering as much ground as possible during the test period; 2) stop

only if they felt too fatigued or breathless to continue; 3) decide, afier stopping, when to

resume walking; and 4) not speak while walking. The tester walked behind the subject in

order to avoid pacing. When the six minutes had elapsed, the subjects were told to stop.

The same rollator was used for al1 subjects, with the height standardized by ensuring

that the handle bars of the rollator were at the level of the subject's ulnar styloid process

(Pierson, 1994). The measured height was kept consistent for both test days.

During each walk test we measured distance walked and perception of dyspnea,

cardiorespiratory variables, gait variables and the arnount of upper extremity weight-bearing

when using the rollator. Pior to each test, we calibrated the respiratory inductance

plethysmograph (Respitrace, Ambulatory Monitoring, Inc., Ardsley, New York) against a

volume spirometer (Morgan Spiroflow, P.K. Morgan Ltd., Rainham, Gillingham). At

completion of the study, subjects were asked to complete a standardized questionnaire to

assess whether they preferred w a h g with or without the rollator (Appendix 8).

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The tester used a trolley to cary the monitoring and acquisition equipment (Figure 1).

For subjects using supplemental oxygen, the portable oxygen canister was also c h e d on the

tester's trolley for each walk test.

Bronchodilator use was standardized by having subjects use their inhaled

bronchodilators thirty minutes before starting each session. CafFeine was withheld for at

least four hours before the study and subjects were instnicted to Wear the sarne footwear on

both study days.

2.2.2 Data Acquisition

The monitoring devices and acquisition equipment were portable and received power

From a 12-volt rechargeable battery. Signals fiom the respitrace inductive plethysmograph,

Morgan Spiroflow, distance sensor, pulse oxirneter, upper extremity weight-bearing sensing

mechanism and stride counter were sampled at 100 Hz using a laptop cornputer (Toshiba

Satellite Pro 410CS) with a data acquisition card (DAQCard-Ai-16X.E-50, National

Instruments, Austin, Texas) and LabVIEW data acquisition and processing software (V5.1,

National Instruments, Austin, Texas). In consultation with a data acquisition engineer From

National Instruments, we adapted a vimial instrument (VI) fiom the LabVIEW library for

data acquisition. A VI is a program in the graphical programrning language G that models

the appearance and huiction of a physical instrument (National Instruments, 1999). The

channels used for data acquisition are depicted in table 8.

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Figure 1: Photograph of tester's trolley set up with monitoring and acquisition equipment.

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Table 8: Data Acquisition Channels

Channel Input

Rib Cage Belt of Respitrace Inductive

Plethysmograph

Abdomen Belt of Respitrace Inductive

Plethysmograph

Oxygen Saturation

Heart-Rate

Distance Sensor

Stride Counter

Upper Extremity Weight-Bearing Sensing

Mechanisrn of RolIator

Morgan Spiroflow (calibration prior to 6-minute walk

test)

The data acquisition card was attached to a shielded connector box (SCB-68, National

Instruments, Austin, Texas) using a one meter 68 pin cable (PSHR68-68, National

Instruments, Austin, Texas). The cornputer, comecting cable and connector box were

secured and carried on the tester's trolley (Figure 1).

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2.2.3 Measures

The measures used for this study are categonzed in table 9 and are described in detail

in the following text.

Table 9: CIassification of LMeasures Prima i

Six-Minute Walk Test Distance (and rests) *

Modified Borg Rating

CRQ - Chronic Respintory Dis1

Secondarv

Cardiorespiratory Firnction VentiIatory Variables + Oxygen Saturation + Hem-Rate +

Gait Stride Length + Walhng Speed + Modified Borg Rating of Leg Discornfort +

P - -

esse Questionnaire; SGRQ - St. George' corresponds prirn&ly to research question I i corresponds prirnuil; to resevch 2 - corresponds primariiy to rcsearch question 3

Demographic Data #

Health-Related Quality of Life (CRQ and SGRQ) #

Upper Extremity Weight-Bearing +

Preference +

--

Respintory Questionnaire

2.2.3.1 Primary Measures

Functional exercise capacity was the primary outcome of this study and was

evaluated by the following two measures.

2.2.3.la Six-Minute Walk Test Distance

A photosensing device (Photoelectric Switch, Omron Corporation, Tokyo,

Japan) was placed on the wheel of the tester's trolley and was used to collect automated

distance measurement via channel 4 of the data acquisition system (Table 8). Additionally,

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the number and duration of rests taken during each six-minute walk test was manually

recorded on the data collection form (Appendix 3).

Validation of the photosensing device occurred prior to the commencement of

data collection by comparing the automated distance measurement to manual measurement

using a meter trundle. Validation was performed at differing waiking speeds ranging fiom

45 rneters per minute (m/min) to 105 m/min. The largest error observed was 0.3 meten

which is clinically insignificant.

2.2.3.1 b Modified Borg Rating of Dyspnea

The modified Borg scale is a comrnonly used tool to evaluate dyspnea during

exercise (Hamilton et al., 1996; Kearon et al., 1991). Consisting of numbers ranging From O

to 10 with descriptive phases anchored to specific numben, it is simple to use and easy for

subjects to understand (Hamilton et al., 1996; Kearon et al., 1991). A copy of the scale c m be

found in appendix 4. The modified Borg scale is a categorical scale; however, it has ratio

properties that allows mathematical manipulation of ratings and the use of parametnc

statistics (Kearon et al., 199 1; Borg, 1982; Borg, 1980).

At the start and completion of each six-minute walk test, subjects were asked

to rate their discomfort of breathing (i.e dyspnea) using the modified Borg scale (Hamilton et

al., 1996; Killian et al., 1992; Kearon et al., 1991; Borg, 1982). These values were

documented on the data collection form (Appendix 3).

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2.2.3.2 Secondary Measures

2.2.3. t a Measures of Cardiorespiratory Function

2.2.3.2ai Ven tilatory Variables

Respiratory inductance plethysmography is a non-invasive respiratory

monitoring technique based on measurement of rib cage and abdominal motion during

breathing (Stromberg et al., 1993; Tobin et al., 1983; Cohn et al., 1982). Two cloth bands

composed of tenon-insulated wire coils are placed around an individual, encircling the rib

cage and abdomen (Stromberg et al., 1993). The Ieads From each coi1 connect to an

oscillator, which is connected to a demodulator (Stromberg et al., 1993; Tobin et al., 1983;

Sackner et ai., 1980). Movement of the chest and abdomen during respiration causes the

cross-sectional area bounded by each of the bands to change, which produces a proportional

change in the self-inductances of the coils (Hodsman et al., 1987; Tobin et al., 1983; Chadha

et al., 1982; Cohn et al., 1982). The changes in inductances are then converted into a

proportional voltage change by the oscillator (Hodsman et al., 1987; RespitraceTM Manual,

1979). Respiratory inductance plethysmography is comrnonly used to evaluate breathing

pattern and minute ventilation and has been validated in individuals with COPD (Tobin et al.,

1983) and during both treadmill and ergometer exercise (Wells et al., 1986; Sackner et al.,

1980).

We used a respiratory inductance plethysrnograph (Respitrace, Ambulatory

Monitoring, Inc., Ardsley, New York) to evaiuate 1) respiratory rate (Le. number of breaths

per minute), 2) the phase relationship of rib cage und abdominal rnovements (i.e. extent of

asynchronous or paradoxical breathing [Gosselink et ai., 1995; Tobin et al., 1 983]), 3) minute

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volume (i.e. volume of air inspired over a minute period) and 4) relative conrribuiion of the

Nb cage and abdominal cornpartments to breathing.

The rib cage band was placed just under the axilla and the abdominal band

was placed below the lowest vertebral rib and just above the iliac crest (Verschakelen et al..

1989; Loveridge et al., 1983; Cohn et al., 1983). The bands were placed directly on the

subject's skin as recornmended by the manufacturer and were secured by surgical tape

(Millman et al., 1986). The electronic oscillator unit was then taped to the chest wall to

eliminate artifacts caused by movement of the unit (Cohn et al., 1982; Sackner et al., 1980).

The demodulator was positioned on the tester's trolley. Data were collected through

channels O and 1 of the data acquisition system (Table 8).

Considering that the respitrace inductive plethysmograph only measures cross

sectional volume under the coils of the bands (i.e. transducer), it is necessary to multiply each

volume (i.e. rib cage and abdomen) by some factor, which compensates for the volume not

rneasured by the transducer (RespitraceTM Manual, 1979). These calibration factors are

determined by c o m p ~ s o n of a volume standard and the respitrace inductive plethysrnograph

(RespitraceiM Manual) using accepted reference equations (Stradling et al., 1985; Chadha et

al., 1982; Cohn et al., 1982; RespitracetM Manual, 1979). These equations can be found in

Appendix 5. Volume measurements obtained with calibrated respiratory inductance

plethysmography have been found to be within ten percent of those denved f?om

simultaneous spirornetry. (Stradling et al., 1985; Tobin et al., 1983; Cohn et al., 1982;

Chadha et al., 1982)

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For this study, calibration was accomplished using a Morgan Spiroflow (P.K.

Morgan Ltd., Rainham, Gillingham) volume spirometer. During calibration, subjects were

asked to stand and breathe through the Morgan Spiroflow for approximately fifteen to hventy

seconds while simultaneously being C O M ~ C ~ ~ to the respitrace inductive plethysmograph.

Calibration occurred immediately before each walk test. Data were collected through

channels O, 1 and 7 of the data acquisition system (Table 8).

2.2.3.2aii Oxygen Saturation and Heart-Rate

Oxygen saniration and heart-rate were acquired continuously with a pulse

oximeter (Ohmeda Biox 3700) through channels 2 and 3 of the data acquisition system

(Table 8). The same oximeter with a finger probe was used for al1 testing. The pulse

oximeter was carried on the tester's trolley. Validation of the linearity of voltage output from

the Ohmeda Biox 3700 pulse oximeter occurred prior to the commencement of data

collection by viewing both oxygen saturation and heart-rate signals on a digitizing

oscilloscope (Mode1 5223, Tektronox Inc., Beaverton. Oregon). For oxygen saturation.

visual verification that 0% oxyhemoglobin saturation (Le. disco~ection) registered as O volts

and that 100% oxyhemoglobin saturation registered as 1 volt occurred. Likewise, for hem-

rate, we confirmed the manufacturer's expected Iinearity of I volt representing a heart-rate of

255 beats per minute. This was accomplished by pmducing heart-rates ranging from O to 112

beats per minute and recording their corresponding voltages.

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2.2.3.2b Measures of Gait

2.2.3.2bi Number of StridesJStride Length

A self-developed stride sensor using a piezo-electric transducer was placed

inside the heel of each subject's right shoe. The sensor was connected to charnel 5 of the

data acquisition system (Table 8). Whenever the heel of the subject's shoe made contact

with the ground during ambulation, a peak voltage was registered (Appendix 6). Output

from the stnde counter was used to derive stride length by dividing distance walked during

each six-minute walk test by number of strides taken. Validation of the stride counter

occurred prior to the commencement of data collection by comparing acquired data with

visual counting of the number of strides taken. Validation was perforrned at differing walking

speeds ranging from 45 meten per minute (rn/rnin) to 105 m/min. Perfect agreement was

found in each trial.

2.2.3.2bii Overall Walking Speed

For each walk test, overall walking speed was denved by dividing distance

walked in six-minutes by the duration of actual walking time (Le. duration of rest was

subtracted fiom the six-minutes).

2.2.3.2biii Modified Borg Rating of Leg Discornfort

The modified Borg scale is also a cornrnonly used tool to evaluate leg

discomfort during exercise (Kearon et al., 1991 ; Neely et al., 1991 ; Wilson & Jones, 1989).

At the start and completion of each six-minute walk test, subjects were asked to rate their

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perceived leg discornfort using the modified Borg scale (Hamilton et al., 1996; Borg, 1982).

These values were documented on the data collection form (Appendix 3).

2.2.3.3 Explanatory Descriptive Measures

Demographic and descriptive data such as age, weight, height, supplemental

oxygen use and FEVl was extracted fkom each subject's medical chart and documented on

the data collection form (Appendix 3). In addition, the following measures were collected

for each subject.

2.2.3.3a Upper Extremity Weight-Bearing

In order to allow measurement of upper extremity weight-bearing when using

the rollator, the rollator (Opal Legacy, Therapist's Choice Medical Supplies, Toronto,

Ontario) was modified (without any change in functionality) by an engineer, to allow

incorporation of two force measuring aluminum beams. Two strain gauges (LY Series

Uniaxial Gauge, Omega Engineering Inc., Lavai, Quebec) were mounted on each beam. The

output of the force signal was amplified by self-made strain gauge amplifiers and connected

to channel 6 of the data acquisition system (Table 8). The weight-bearing sensing

mechanism was calibrated and zeroed on each study day. Prior to the commencement of data

collection, we calibrated the mechanism and established its linearity by comparing known

weight sources (Le. fYee weights verified by a universal scale with an error of 0.05 kilograms)

and the corresponding voltage output. This calibration was performed with a range of

weights ranging fiom 0.25 to 14.43 kilograms at each of the available heights of the rollator.

Linear regression analysis of these data showed that the relationship between weight applied

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to the rollator and voltage output was linear over the range of weights measured (r=1.00,

p~0 .00 1). The linearity of the weight-bearing sensing mechanism is shown in Appendix 7.

2,2,3.3b Subject Preference

Subjects were requested to complete a standardized preference questionnaire

at completion of the study (Appendix 8). The preference questionnaire was intended to serve

as a means of determining each subject's preference for ambulation during the six-minute

walk test (i.e. with or with out rollator) and the reasons for this preference. This

questionnaire was piloted for content and clarity by two patients with COPD and clinicians

with expertise in respiratory rehabilitation. The questionnaire took approximately three

minutes to complete.

2.2.3.3~ Health-Related Quality of Life

Subjects were requested to complete the St. George's Respiratory

Questionnaire (SGRQ) during the study week (Appendix 9). The SGRQ is a disease-specific

instrument developed for individuals with COPD and designed to measure health-related

quality of life (Jones et al., 1992; Jones et al., 1991). The SGRQ c m be used as both an

evaluative and discriminative measure (Lacasse et al., 1997b). It contains 76 items divided

into three sections: symptoms, activity and impacts (Jones et al., 1991). This instrument was

self-administered, taking approximately ten minutes to complete (Jones et al., 199 1; Jones et

al., 1992). Subjects were reassured that there was "no right or wrong answer" and that they

should answer the questions as they interpreted them. The data collector was available to

provide clarification as necessary. Scores for each section and a total score were calculated.

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Scores range from O to 100, with higher scores indicating poor health related quality of life

(Jones et al., 1992; Jones et al., 1991).

Additionaily, Chronic Respiratory Disease Questionnaire (CRQ) scores were

obtained from each subject's medical chart and documented on the data collection form

(Appendix 3). The CRQ is another disease specific health-related quality of life

questionnaire (Lacasse et al., 1997~); however, it is administered by a trained interviewer and

measures the domains of dyspnea, fatigue, emotional h c t i o n and mastery (Lacasse et al.,

1997~). It is primarily used as an evaluative mesure in clinical trials and treatment

prograrns; however the domains of fatigue, emotional function and mastery can be used to

discriminate arnong patients with less versus more severe quality of life loss (Lacasse et al.,

1997c)

2.2.4 Data Processing

Calibration and test files were transferred from the laptop computer to a desktop

computer using a parallel port data transfer cable and direct cable connection software

(Micmsofi Windows 98). Test files were imported into Excel (Microsoft, 1997) and were

split into six separate minute intervals. Variables were described and analyzed for the entire

six minute duration as well as for each individual minute of each walk test.

Mean oxygen saturation, heart-rate and upper-extremity weight-bearing were

determined using SigrnaStat statistical software 012.03, SPSS Inc, Chicago, Illinois).

Distance walked and number of strides were calculated in Excel (Microsofl, 1997).

Ventilatory variables (Le. respiratory rate, phase relationship of rib cage and

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abdominal movements, minute volume and relative contribution of the nb cage and

abdominal compartments to breathing) were caiculated using a VI created by a biomedical

engineer using LabVIEW graphical programming software (V5.1, National uistments,

Austin, Texas). Respitrace inductive plethysmograph signals from each subj ect were

imported into the VI, calibrated using the signal fiom the Morgan Spiroflow, filtered in

accordance with Nyquist's sampling theory (Brook & Wynne, 1988) using the subject's

respiratory rate as the highest frequency component of the signal and analyzed in minute

intervals. The phase relationship of the nb cage and abdominal compartrnent was determined

by manually calculating and averaging the phase angles for the last three breaths of each

minute (Appendix 10). Zero degrees indicate that the signals are perfectly in phase (Le.

synchronous breathing) while 180 degrees indicate that signals of the rib cage and abdomen

are cornpletely out of phase (i.e. paradoxical breathing) [Gosselink et al., 19951. Minute

volume was determined by calculating and summing the difference (in litres) between the

peak and valley of each breath for the minute interval. Relative contribution of the rib cage

and abdominal compartments was determined by arbitrarily taking a ratio of the surface area

of n b cage excursion to the surface area of abdominal excursion. To aid in the interpretation

of these variables, data was collected on normal subjects (Appendix 1 1).

2.2.5 Statistical Analysis

For the primary and secondary meastues of interest, means, standard deviations and

standard errors were calculated for the six-minute w a k test conducted with and without the

rollator. Descriptive statistics were also used for the explanatory variables of interest such as

age, height, weight, FEVI, health related quality of life scores, subject preference and amount

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of upper extremity weight-bearing. Pararnetric statistics were used for ratings of dyspnea and

leg discomfort due to the modified Borg scale's established ratio scale properties.

To detemine whether there was a difference between the prirnary and secondary

outcorne rneasures for the six-minute walk test conducted with and without the rollator, two-

way repeated measures analysis of variance (ANOVA) was used. When a significant

difference was found, post-hoc znalysis was performed using a Tukey test.

In order to determine which individuals would benefit most from using a rollator,

univariate regression was performed in order to explore the relationship between change in

functional exercise capacity (i.e. distance walked or perception of dyspnea) using the rollator

and specific independent variables (e.g. age. FEV!, use of supplemental oxygen). Stepwise

multiple regression analysis was then performed to determine the relationship between the

significant variables (as determined by univariate regression) and change in hinctional

exercise capacity using the rollator.

in order to determine if preference had an effect on outcorne, one-way ANOVA was

perfomed on the prirnary measures of interest between subjects who preferred using the

rollator, subjects who had no preference and subjects who preferred to walk unaided.

Additionally, chi-square analysis was performed to determine if level of disability was

related to preference.

Statistical analysis was undertaken using SigmaStat (V2.03, SPSS Inc, Chicago,

Illinois) and SigrnaPlot (V5.0, SPSS inc, Chicago, Illinois) statistical software. For al1

statistical analyses, p values of 0.05 or less were considered significant.

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Chapter 3: Results

For each variable, results are given for the total sample (n=40) and for a subgroup of

subjects who walked less than 300 meters unaided (n=19). The latter was included based on

the data presented in section 3.4.1, which indicated a potential relationship between baseline

measure of disability (i.e. unaided six-minute walk test distance) and change in functional

exercise capacity using the rollator. Additionally, for the primary measures of interest, results

are given for subjects who waiked m e r than 300 meters unaided.

3.1 Samale Characteristics -

Twenty-one male and nineteen female subjects with severe COPD participated in the

study. Ten of the subjects required supplemental oxygen for exertion. Of the forty subjects,

nineteen walked less than 300 meters during the unaidrc! cil-minute walk test. General

charactenstics of the total sample and of those who walked less than 300 meters unaided are

shown in table 10.

3.2 Primarv Outcornes - 3.2.1 Six-Minute Walk Test Distance

There was no statistically significant difference in (mean i SE) six-minute walk test

distance using the rollator (R) compared to without (NR) for the total sarnple ([RI 3 17.0 2

15.7 vs. [MZ] 3 11.6 2 16.6 ml p=0.3) or for subjects who walked further than 300 meters

unaided ([RI 384.4 + 16.4 vs. w] 394.3 + 13.9 ml ~ 4 . 1 ) . However, subjects who walked

less [han 300 meters unaided, walked M e r with the rollator ([RI 242.5 + 14.2 vs. [NR]

220.3 + 12.0 ml p4.02). These results are illustrated in figure 2.

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Table 10: General Characteristics of Sample

Il Age (years)

Variable

Sex

1 Supplernentai Oxygen Required (Umin) 1 l2

Total Sample ( ~ 4 0 )

21 male; 19 female

Weight (Kg)

Keight (cm)

Number (%) of Subjects on Supplemental Oxygen

FEV, (% Predicted) 36.1 5 2.0

Subjects Who Walked < 300 meters Unaided

(n=19) 12 male: 7 fernale

Total CRQ Score 78.9 2 3.4 81.425.1

7 1.2 2 2.3

165.8 2 1.5

10 (25.0%)

CRQ Dyspnea Domain Score 15.2 5 0.8 15.6 2 1.2

75.3 2 3.0

167.3 + 2.0

7 (36.8%)

CRQ Emotiond Function Domain Score 31.1 + 1.5 31.9 2 2.2 L

CRQ Fatigue Domain Score 15.2 2 0.8 15.3 2 1.2 i

11 CRQ ~Mastery Domain Score 1 17.1 2 0 . 9 1 17.8 t 1.2

SGRQ Total Score (%) 5 1.7 2 2.6

SGRQ Symptoms Score (%) 59.4 2 3.0

SGRQ Activity Score (%) 72.1 2 2.9 78.1 2 3.6

SGRQ Impacts Score (%) 37.8 2 3.1 37.3 2 5.0

Data are presented as mean 2 standard error (SE)

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Figure 2: Cornparsion of total distance walked unaided (NR) and with rollator (R) for A) the total sample, 6) subjects who walked less than 300 meters unaided and C) subjects who walked greater than 300 meters unaided. Open circles represent individual data points. Solid squares represent mean + standard error.

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Mean distance waked each minute of the six-minute walk test is shown for the total

sample and for subjects who walked less than and greater than 300 meters in figure 3. ui both

the total sample and the subgroup of subjects who waked less than 300 meters unaided, there

was a decline in distance walked during the middle of the six-minute walk test (i.e. minutes

two to four) and an increase in distance walked at the end portion of the test (i.e. minutes four

to six). This pattern was consistent regardless of rollator use and was not present for subjects

who waiked greater than 300 meten.

We examined the effect of the rollator on distance walked each minute of the six-

minute walk test in the total sample. Dunng the first minute, these subjects walked further

unaided ([RI 54.4 + 2.4 vs. [NR] 57.3 + 2.2 m, p<0.001); however, there was no significant

difference in distance walked for minutes two, three, Four, five or six (p>0.1). The

interaction between time (Le. minute) and aid was significant (pc0.001).

The sarne analysis was performed for the subgmup of subjects who walked less than

300 meters unaided. These subjects also walked significantly further wirhout the rollator

during the fint minute ([RI 44.1+ 2.2 vs. [NR] 47.8 + 1.8 m, p<O.OOl); however, they walked

significantly M e r wirh the rollator for minutes three ([RI 40.4 2 2.2 vs. [NR] 34.0 + 1.9 m,

p=0.01), four ([RI 35.7 + 3.1 vs. [M(] 28.3 2 3.2 m, p=0.03), five ([RI 37.3 + 3.5 vs. [NR]

3 1.4 + 3.5 m, p=0.02) and six ([RI 39.9 + 3.8 vs. IM(] 34.3 53 .9 m, p=0.02). The interaction

between thne (i.e. minute) and aid was also significant @<0.001) and distance waiked each

minute was l e s variable with use of the rollator (Figure 3B).

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Minute Minute Minute

Figure 3: Mean + standard error distance walked unaided (NR] (closed circles) and with the rollator (RI (open circles) each minute of the six-minute walk test for A) the total sample, B) subjects who walked less than 300 meters unaided and C) subjects who walked greater than 300 meters unaided.

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3.2.2 Duration of Rest

The change in rest duration is s h o w in figure 4. Subjects rested for 11.9 5.8

seconds using the rollator during the six-minute walk test compared to 31.2 + 8.7 seconds

without @=0.001). Similarly, a statistically significant reduction in duration of rest with the

rollator was also observed for subjects who walked less than 300 rneters unaided ([RI 24.3 f

11.6 vs [NR] 64.7 2 15.0 seconds, p<O.001). A cornparison of rest time for those who

walked further than 300 meten unaided was not performed, as only subject in this subgroup

required a rest.

3.2.3 Modified Borg Rating of Dyspnea

Use of the rollator resulted in a statistically significant reduction in the perception of

dyspnea, both for the total sample (IR] 1.8 + 0.2 vs. [NR] 2.7 + 0.3 unit change, peO.001)

and for those who walked less thon 300 meters unaided ([RI 1.8 + 0.3 vs. [NR] 3.2 5 0.4 unit

change, pc0.001). A statistically significant reduction in breathlessness with the rollator was

also found for those who walked further han 300 meters unaided ([RI 1.7 50.2 vs m] 2.2

+ 0.3 unit change, p=0.03). Figure 5 illustrates these results. Pre- and post-test dyspnea -

ratings for the total sarnple and those who walked less than and greater than 300 meters are

presented in table 1 1.

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Figure 4: Camparison of duration of rest during the six-minute walk test when walking unaided (NR) and with the rollator (R) for A) the total sample and 8) subjects who walked less than 300 meters unaided. Open circles represent individual data pointssolid squares represent rnean + standard error.

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3.3 Secondary Outcornes -

3.3.1 Cardiorespiratory Function

3.3.1.1 Ventilatory Variables

There was no significant difference in respiratmy rate during the six minutes,

with the rollator compared to without, for the total sample (p=0.4) or for those who walked

less than 300 meten unaided (p=0.8) [Figure 61.

The phase relationship of the rib cage and abdomen during the six-minute

walk test, with and without the rollator. is shown in figure 7. No statistically significant

difference was found for the total sample (p=0.6) or for those who walked less than 300

meters unaided (p=0.5).

Use of the rollator did not result in a significant change in minute voZtrme

during the six minute walk test for the total sample (p=0.4) or for those who walked less than

300 meters unaided (p=0.4). These results are illustrated in figure 8.

The ratio of the contribulion to breathing of the rib cage to abdomen was

not significantly different when using the rollator compared to walking unaided, for the total

sample (p4.8) or for those who walked less than 300 meters (p=0.8) [Figure 91.

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Figure 6: Comparison of respiratory rate dunng the six-minute walk test when walking unaided (NR) and with the rollator (R) for A) the total sample and B) subjects who walked less than 300 meters unaided. Open circles represent individual data points. Solid squares represent mean 2 standard error.

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Figure 7: Cornparison of the phase relationship of the rib cage and abdomen during the six-minute walk test when walking unaided (NR) and with the rollator for A) the total sample and 8) subjects who walked less than 300 meters unaided. Open circles represent individual data points. Solid squares represent rnean + standard error. -

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Figure 8: Cornparison of minute volume during the six-minute walk test when watking unaided (NR) and with the rollator (R) for A) the total sample and 8) subjects who walked less than 300 meters unaided. Open circles represent individual data points. Solid squares respresent mean 2 standard error. Note that data was available for twenty and nine subjects, for Graphs A and B respectively.

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Figure 9: Cornparison of the ratio of the contribution to breathing of the rib cage to the abdomen, during the six-minute walk test when walking unaided (NR) and with the rollator (R) for A) the total sample and 0 ) subjects who walked less than 300 meters unaided. Open circles represent individual data points. Solid squares represent mean + standard error. Note that data was available for twenty and nine subjects, for Graphs A and B respectively.

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3.3.1.2 Oxygen Saturation and Heart-Rate

Use of the rollator did not result in a significant difference in oxygen

saturation during the six-rninute walk test, for the total sample (p=0.2) or for those who

waked less than 300 meten unaided (p=0.1) [Figure 1 O].

There was a statistically significant decrease in heart-rate using the rollator

during the six-minute walk test for the total sample ([RI 102.5 2 1.8 vs. [NR] 105.9 + 1.9

beats per minute, p=0.02). This difference was the result of lower hem-rates in minutes one

and six ( ~ ~ 0 . 0 3 ) ; however, this change was not clinically significant (Thomas, personal

communication). No significant difference was found for those who walked less than 300

rneters unaided (p=0.2). These resuits are illustrated in figure 1 1.

3.3.2 Gait

3.3.2.1 Stride Length

There was no difference in stride length during the six-minute walk test when

using the rollator cornpared to walicing unaided, for both the total sample (p=0.2) and for

those who walked less than 300 meten unaided (p=0.2) [Figure 121.

3.3.2.2 Overall Walking Speed

Use of the rollator resulted in a statistically significant reduction in walking

speed for the total sample ([RI 54.4 2 2.4 vs. [NR] 56.1 2 2.2 m/min, p=0.007); no difference

was observed for the subgroup of subjects who walked less than 300 meters unaided (p=0.1).

Fisure 13 depicts overall waking speed with and without the rollator.

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Figure 10: Cornparison of oxygen saturation during the six-rninute walk test when walking unaided (NR) and with the rollator (R) for A) the total sample and B) subjects who walked less than 300 meters unaided. Open circles represent individual data points. Solid squares represent mean 2 standard error.

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Figure II: Cornparison of heart-rate dunng the six-minute walk test when walking unaided (NR) and with the rollator (R) for A) the total sample and B) subjects who walked less than 300 meters unaided. Open circles represent individual data points. Sotid squares represent mean + standard error. -

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Figure 12: Cornparison of stride length during the six-minute walk test when walking unaided (NR) and wi# the rollator (R) for A) the total sample and 8) subjects who walked less than 300 meters unaided. Open circles represent individual data points. Solid squares represent mean 2 standard error.

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Figure 13: Cornparison of overall waiking speed during the six-minute walk test for walking unaided (NR) and with the rollator (R). Graph A depicts the total sarnple and graph B porûays subjects who walked less than 300 meters unaided. Open cîrcles represent individual data points. Solid squares represent mean + standard ertor.

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3.3.2.3 Modified Borg Rating of Leg Discornfort

Use of the rollator also resulted in a statistically significant reduction in the

perception of leg discomfort for the total sample (CR] 0.3 2 0.1 vs. [NR] 0.5 2 0.2 unit

change, p=0.01); no significant difference was found for those who walked less than 300

meters unaided (p=O. 1) Figure 141. Note that the majority of subjects reported no change in

perception of leg discomfort kom the beginning to the end of six-minute walk test, both

when walking unaided and with the rollator. As a result, the disproportionate number of zero

values may have skewed the results. Additionaily, the clinical significance of this result is

questionable.

3.4 Ex~laaatorv Descriptive Measures -

3.4.1 Baseline (Le, Unaided) Six-Minute Walk Test Distance

Respiratory disability is oRen assessed by the six-minute walk test (Amencan

Thoracic Society, 1999). The literature suggests that a six-minute walk test distance of 300

meters is a potential threshold value for level of disability (Honeyman et al., 1996; Goldstein

et al, 1994). As such, we exarnined the relationship beiween baseline level of disability (Le.

unaided six-minute walk test distance) and change in distance waiked with use of the rollator.

Figure 15 illustrates that subjects who waiked less than 300 meten unaided tended to show

improvement in waking distance with the rollator, whereas those who were able to walk

greater than 300 meters, appeared to exhibit either no change or a detenoration in

performance.

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Change in Modified Borg Rating of Leg Discornfort

Change in Modified Borg Rating of Leg Discornfort

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O 1 O0 200 300 400 500 600 700

Unaided Six-Minute Walk Test Distance (m)

Figure 15: Scatter plot s howing the relationship between baseline measure of disability (i.e. unaided six-minute walk test distance) and change in distance walked with the rollator. Solid circles above dotted line indicate improvement in distance walked with the rollator while those below indicate deterioration. Solid line indicates that those who walked less than 300 meters unaided tended to show improvement in walk test distance with the rollator while those who walked greater than 300 meters appeared to exhibit either no change or a deterioration in performance.

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3.4.2 Upper Extremity Weight-Bearing

During the six-minute waik test, the amount of upper extremity weight-bearing on the

rollator was 5.0 + 0.3 kg. This arnounted to 7.0 5 0.4 % body weight. Likewise, for those

who waiked less than 300 meters unaided, 5.5 & 0.5 kg of weight or 7.4 & 0.6 % body weight

was placed on the rollator. Table 12 shows the amount of upper extremity weight-bearing for

each minute of the six-minute walk test.

Table 12: Amount of Upper-Extrernity Weight Bearing During Each Minute of the Six- Minute Walk Test

Minute 1 Total Sample Subjects Who Walked < Subjects Who Walked 300 Meters Unaided > 300 ,Meters Unaided

Data are presented as mean 2 SE,

The relationship between the amount of weight applied to the rollator and change in

distance walked with the rollator (i.e. [RI distance walked - [NR] distance walked) was weak

and not significant for the total sample ( ~ û . 3 , p=0.1) and for subjects who waked less then

300 meten unaided ( d . 2 , p=0.4) [Figure 161. Similar hdings were found for the

relationship between the arnount of weight applied to the rollator and change in modified

Borg rating of dyspnea (60.3, pM.3) Figure 171.

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O

Figure 16:

Weight Appiied to Roiiator (% Body Weight)

Weight Applied to Rollator (% Body Weight)

Relationship behveen amount of weight applied to rollator and change in distance walked with the rollator for A) the total sample and 6) subjects who walked less than 300 meters unaided. Solid circles above dotted line indicate improvement in distance walked wiai rollator while those below indicate deterioration.Solid line, calculated Iinear regression.

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Change in Modified Borg Rating of Dyspnea [Rollator Change - Unaided Change]

Change in Modified Borg Rating of Dyspnea [Rollator Change - Unaided Change]

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3.4.3 Sub ject Preference

Fifty percent of subjects (n=20) preferred using the rollator for the six-minute walk

test; 17.5% (n=7) had no preference and 32.5% (n=13) preferred to walk unaided. Fourteen

of the nineteen subjects who waiked less than 300 meters unaided preferred the rollator; one

had no preference and four preferred to waik unaided. The nurnber and percentage of

subjects' agreement with specific statements pertaining to the rollator (Appendix 8) are

shown in table 13.

Table 13: Agreement with Statements Pertaining to Use of the Rollator During the Six-Minute Walk Test for the Total Sample

No significant difference was found between subjects who preferred the mllator,

subjects who had no preference and subjects who preferred to walk unaided for change (i.e.

R-NR) in distance walked, modified Borg rating of dyspnea or duration of rest (one-way

ANOVA, pX.2). However, level of disability (Le. unaided six-minute walk test distance

greater or less than 300 meten) and preference were significantly related (Chi-square,

p=0.01) [Table 141.

Statement

Breathe Easier

Feel Safer

DifEcult to Push

Impaired Walking

Strongly Agree Or Agree

Count (%) 25 (62.5)

24 (60.0)

1 (2.5)

O (0.0)

Neither Agree Nor Disagree

Count (%) 1 1 (27.5)

9 (22.5)

1 (2.5)

6 (15.0)

Strongly Disagree Or Disagree

Count (%) 4 (10.0)

7 (17.5)

38 (95)

34 (85)

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Table 14: Subject Preference Categorized According to Level of Disability

1 Subjects who Preferred Rollator 1 14

Subjects who Walked > 300 m

on the Six-Minute Walk Test

Subjects who Preferred to Walk Unaided or bad who had no

Preference

3.4.4 Univariate Regressioa Analysis

Baseline measures of impairment (i.e. FEV,), disability (Le. unaided six-minute walk

test distance less than or greater than 300 meters) and quality of life (Le. CRQ and SGRQ

5

scores) as well as other descriptive variables (i.e. use of supplemental oxygen, requirement of

a rest during the unaided six-minute walk test, baseline rating of dyspnea and age) were

evaluated as potential independent predictors of improvement in six-minute walk test

distance and perception of dyspnea with use of the rollator (Table 15). Simple regression

analysis revealed that unaided six-minute walk test distance and requirement of a rest during

the unaided six-minute wak test were significant for both improvement in six-minute waik

test distance and dyspnea sensation (Table 15).

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Table 15: Univariate Regression Analysis Between Potential Predictor Variables and Improvement in

Uuaided Six-Minute Walk 40 Test Distance

(i.e. > or < 300 ml Health-Related Quality of 36

Life Scores+ Use of Supplemental 40

Oxygen Requirement of a Rest 40 During Unaided Six-

LMinute Walk Test Baseüne Modifted Borg 39

Rating of Dyspnea Aee 40

- - - - -- -- - - - -

* denotes statistical significance

WAlLKED DYSPNEA ,

R P Value n R P Value 0.15 0.42 36 O. 1 O 0.57 0.48 0.002" 39 0.38 0.02*

+ includes total and domain scores for CRQ and SGRQ

3.4.5 Multivariate Regression Analysis

Using the significant variables identified in simple linear regression (Le. unaided six-

minute walk test distance less than or greater than 300 meters and requirement of a rest

dunng the unaided six-minute walk test), multiple regression analysis (Le. stepwise

regression) revealed that requirement of a rest during the unaided six-minute walk test was

predictive of improvement in both distance walked and perception of dyspnea with the

rollator (Table 16). Unaided six-minute walk test distance did not significantly add to the

ability of the either mode1 to predict improvement (Table 16). This is likely to due to the

strong and significant relationship between the two variables (r= -0.67, p<0.001).

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Table 16: Multiple Regression Analysis Between Predictor Variables Identified with Simple Linear Regression and Improvement in Functional Exercise Capacity (i.e. Distance Walked and Perception of Dyspnea) with Rollator

Unaided Six-Minute Walk Test Distance

(i.e. > or < 300 m)

Requirement of a Rest <O.OO 1 * During Unaided Six- Minute Walk Test

(R-NR) CHANGE m DYSPNEA

P Value

* denotes statistical significance

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Chapter 4: Discussion

4.1 Summary -

Three research objectives were formulated for this study: to establish the short-term

effect of a rollator on lunetional exercise capacity in individuals with COPD, to determine

which individuals would benefit most fiom using a rollator and to provide insight into the

mechanisms that may be responsible for improvement in functional exercise capacity with

use of a rollator.

Our results indicate that use of a rollator results in an improvement in functional

exercise capacity in tenns of a reduction in breathlessness and a lessening of rest iime

required. Individuals with severe COPD who are unable to walk greater than 300 meters

and/or who require a rest during the six-minute walk test will benefit most From using a

rollator by reducing breathlessness and rest time and by improving distance walked. Finally,

we found that improvement in huictional exercise capacity with use of a rollator is not due to

changes in breathing pattern or gait.

This is the fint study to characterize which individuals with COPD benefit most from

using a rollator and to provide insight into the mechanisrns responsible for improvement in

functional exercise capacity with use of a rollator.

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4.2 Cornparisons to Other Studies -

Our sample consisted of forty individuals (mean age 68 years), with puimonary

Function testing indicative of severe COPD (mean FEVi 36% predicted). Three previous

studies examining the effectiveness of wheeled walking aids in individuals with COPD also

evaluated individuals with severe COPD [mean FEVl 30-33% predicted] (Honeyman et al.,

1996; Wesmiller & H o h a n , 1994; Grant & Capel, 1972), while one used a less impaired

sample [mean FEVl 50% predicted] (Roomi et al., 1998). Honeyman and colleagues (1996)

and Roomi and colleagues (1998) samples were slightly older (71 and 75 yean), while those

of Wesmiller and Hoffman (1994) and Dalton and colleagues (1995) were slightly younger

(63 and 65 years). Sample sizes of these studies are considerably smaller than ours, ranging

hom one to twelve subjects (Roomi et al., 1998; Honeyman et al., 1996; Dalton et al., 1992;

Wesmiller & Ho f i a n , 1994; Grant & Capel, 1972; Campbell, 1957).

Our findings of an increase in distance walked in individuals who are most disabled

are consistent with those of Honeyman and colleagues (1996) and Wesmiller and H o h a n

(1994). Honeyman and colleagues found that individuals who walked l e s than 300 meters

during the six-minute walk test improved wak test distance by approximately 34 meten

when using a rollator. In this study, we reported an improvement of 22 meters. There were

slight differences in study design; Honeyman and colleagues (1 996) required subjects using

supplemental oxygen to pull their oxygen canisters only during the unaided six-minute waik

test. The increased metabolic cost t o m having to pull their portable oxygen may have

limited exercise capacity during the unaided wak test. Wesmiller and H o h a n (1994) also

found that the six individuals in their sample with twelve minute walk test distances of less

than 1000 feet (Le. 305 meten) walked 226 feet (Le. 69 meters) funher with the rollator.

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Assuming that these findings could be extrapolated to performance on the six-minute walk

test, these individuals would have waiked approximately 34 meten m e r with the rollator.

This is the same value reported by Honeyrnan and colleagues (1996) and is somewhat

comparable to the results of our study.

We found that use of the rollator resulted in a one unit reduction in the perception of

dyspnea (i.e. on the modified Borg scale) for the total sample and a more pronounced effect

(i.e. 1.4 unit reduction) for those who were most disabled. These results are consistent with

Honeyman and colleagues (1 996) and Dalton and colleagues (1 995) who found a greater than

one unit reduction in perception of dyspnea associated with using a rollator.

Our finding of no change in oxygen saturation when using the rollator is consistent

with previous investigations (Roomi et al., 1998; Dalton et al., 1995). Although Honeyman

and colleagues (1996) reported a significant reduction in hypoxemia (Le. 2%) with use of a

rollator, the clinical importance of their finding is questionable. Honeyman and colleagues

(1996) did not provide baseline oxygen saturation values and therefore, it is difficult to

evaluate the clinical significance of the reduction in hypoxemia. When baseline oxygen

saturation is above 90%, a two percent difference is not reflective of a clinically important

change in the amount of oxygen dissolved in blood plasma. However, if baseline oxygen

saturation is below 85%, a two percent difference may be of greater clinical importance

(Frownfelter, 1996; Sherwood, 1993).

Our hding of no change in minute volume when using the rollator is in agreement

with the only snidy that evaluated the effect of a wheeled w a k n g aid on ventilation in

individuals with COPD (Grant & Capel, 1972). These researchen evaluated minute volume

with a Wright respirometer in their sample of five males with severe COPD and found no

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change with use of a wheeled walking aid (Grant & Capel, 1972). Other studies have

reported reductions in minute ventilation with supported venus non-supported arms during

treadmill w a k n g in healthy individuals (Parrillo et al., 1991; Zeimetz et al., 1985).

However, ami support provided by a treadmill is not comparable to using a rollator.

Furthemore, while some studies have found treadmill and corridor floor walking tests to be

equivalent measures (Peeten & Mets, 1996; Beaumont et al., 1985), othen have found

significant differences in energy cost and performance (Stevens et al., 1999; Swerts et al.,

1990; Pearce et al., 1983). An individual is able to control hislher walking speed when

performing a corridor test, whereas the speed of walking is externally controlled during a

treadmill evaluation.

Grant and Cape1 (1972) explored the effect of a wheeled walking aid on overall

walking speed in individuals with COPD. They found a 3.7 m/min reduction in wallcing

speed associated with an improvement in distance walked. The improvernent in distance

walked occurred by an increase in endurance because the evaluative walk tests were not

tirne-limited and subjects were allowed to walk as far they could. Although we found no

overall difference in six-minute walk test distance, use of the rollator resulted in a 1.7dmin

reduction in walking speed. Convenely, while we did find an improvement in distance

walked with the rollator for our subgroup, no significant change in walking speed was found.

This is the first study to investigate the effect of a wheeled walking aid on heart-rate,

respiratory rate, respiratory pattern, perception of leg discornfort and stride length in

individuals with COPD. We found no statistically and/or clinically significant change in any

of these variables walking with the rollator compared to without in both our total sample and

subgroup.

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4.3 Research Ouestions 1 & 2 - Determinine the Effect o f a Rollator on Functional

Exercise Ca~acitv and the Individuals Who Ben efit Most

Functional capacity has been defined as the ability to undertake physically demanding

activities of daily living (Guyatt et al., 1985a). Calverley (2000b) has suggested that the

improvement of an intervention on functional exercise capacity can be manifested in one of

two ways for individuals with COPD. Individuals may choose to exercise to the same level

of breathlessness as previously, but because they are less distressed, they are able to walk

further (Calverley, 2000b). Alternatively, they may walk the same distance, but experience

less breathlessness (Calverley, 2000b). Using these standards, our findings show that use of a

rollator improves functional exercise capacity by reducing the perception of dyspnea. For

individuals who are unable to walk further than 300 meten and/or who require a rest during

the six-minute walk test, use of a rollator results in a more pronounced improvement in

functional exercise capacity by reducing the perception of dyspnea while at the same time

increasing distance walked.

The improvement in distance walked by our subgroup of subjects who walked less

than 300 meters was 22 meters. Redelmeier and colleagues (1997) established that a minimal

mean change in six-minute walk test distance of 54 rneten represented a clinically significant

change in hct ional status. Using this cntenon, our results are not clinically significant.

However, Redelmeier and colleagues (1997) used a COPD population with an average six-

minute walk test distance of 371 meters. Given that our subgroup walked 220 meters during

the unaided six-minute walk test, a less than 54 meter change in distance walked may be

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clinically significant. The majority of the subgroup (Le. 74%) preferred using the rollator for

the walk test, indicating that the improvement was clinically important.

Dyspnea is the distressful sensation of uncornfortable breathing and shortness of

breath (Breslin, 1992). It is the most comrnon syrnptom that limits function and exercise in

individuals with COPD and as such, sorne authon argue that it should be regarded as a

primary outcome rneasure in any study that evaluates the success of an intervention in this

population (O'Donnell, 1998; O'Domeli et al., 1995; Jenkins et al., 1995). Although there is

no published information on what precisely constitutes clinical improvement for the

perception of dyspnea using the modified Borg scale, clinical experience suggests that a one

unit or greater reduction is clinically important (O'Domeli, persona1 communication). Using

this criterion, our results pertaining to the effect of a rollator on breathlessness are considered

clinically significant. This is further supported by the fact that the majority of subjects (Le.

63%) felt that the rûllator allowed them to breathe easier during the walk tests.

The outcome of duration of rest has received little attention in the literature. Menard-

Rothe and colleagues (1 997) reviewed studies evaluating exercise tolerance using time-based

fùnctional waik tests and found that no investigation reported the total rest time taken during

performance of the walk tests. It is difficult to accurately interpret the full extent of

fûnctional capacity (e.g. independent comrnunity ambulation) with the absence of such

information (Menard-Rothe et al., 1997). Our findings of reduction in rest time for the total

sample (i.e. 19 seconds) and subgroup of subjects who walked less than 300 meten (Le. 40

seconds) has important implications, especially since a reduction in dyspnea and an increase

in distance walked (Le. subgroup only) occurred concurrently. To be able to rest for a shorter

period of time, experience less shortness of breath yet still walk M e r in the same time

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period with a rollator compared to without, is considered an irnprovement in functional

ability and is therefore assumed to be meaningful to an individual (Menard-Rothe et al.,

1997).

4.3.1 Clinical Implications of Findings

An individual with severe COPD who walks less than 300 meten andlor who requires

a rest during the six-minute walk test will benefit most from using a rollator. It is also

important to have an understanding of the patient's circumstances, values and beliefs and

incorporate them into each clinical recomrnendation (Guyatt et al., 2000; McAlister et al.,

2000). Although we established the positive effect of a rollator on hctional exercise

capacity (i.e. reduction of breathlessness, decrease in rest time required and improvement in

distance walked) for individuals with severe COPD, 33% of our total sample and 2 1 % of our

subgoup preferred to walk unaided. Patient concems of the 'stigrna' associated with using a

mobility aid, appearance of the aid, cost and perception of benefit must also be taken into

consideration.

From a clinical perspective, this study may have underestimated the effect of' a

rollator on functional capacity in individuals with severe COPD. Some of the advantageous

features of a rollator were not considered. First, because equipment modification was

necessary to allow the incorporation of an upper extremity weight-bearing sensing

mechanism. the seat of the rollator was removed. Having a seat readily available allows an

individual the security of knowing helshe is able to rest anywhere at anytime. This feature

rnay serve to reduce the anxiety and fear many individuals with COPD have when embarking

on community ambulation. Second, this study did not make use of the basket attached to the

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rollator. This feature allows individuals to cany persona1 belongings a d o r shopping

purchases. Most importantly, for individuals who require supplemental oxygen, the basket

allows housing of the portable oxygen canister. Typically, individuals carry their oxygen

canisters on a cart or with a shoulder strap. In this study, the oxygen canister was carried on

the tester's trolley for both the independent and 'rollator' walk tests. The reduction in

metabolic cost frorn not having to pull their portable oxygen may result in hinher

improvements in hinctional exercise capacity (Honeyrnan et al., 1996).

Research Ouestion 3 - Ins i~h t into Mechanims

This is the fint study to provide insight into some of the potential mechanisms that

may be responsible for improvement in functional exercise capacity with use of a rollator in

individuals with COPD.

The clinical importance of observing the synchrony of motion of the nb cage and

abdomen (Le. breathing pattern) has been supported in the Iiterature (Macklem, 1980; Sharp

et al., 1977; Ashutosh et al., 1975). Asynchronous or paradoxical motion between the two

compartments suggests ineffective diaphragmatic function (Siafakas et al., 1995; Celli et al.,

1986; Gilbert et al., 1981; Ashutosh et al., 1975; Sharp et al., 1977). With ineffective

diaphragmatic function, the inability to generate effective inspiratory force results in the

diaphragm being moved upwards by the negative intrathoracic pressure generated by the

intercostal muscles (Delgado et al., 1982; Sharp et al., 1977). While previous studies have

used qualitative evaluations of the phase relationship of the rib cage and abdomen (Breslin et

al., 1990; Celli et al., 1986), we were able to quanti@ the extent of asynchronous movement.

Nevertheless, our hypothesis that change in breathing pattern induced by the rollator, was not

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supported. In fact, no significant differences in any of the ventilatory variables studied were

found when w a h g unaided compared with using the rollator. Although no previous study

has evaluated diaphragmatic function, investigations showing positive effects of wheeled

walking aids for individuals with COPD have used high-wheeled waiking aids (Roomi et al.,

1998; Grant & Capel, 1972; Campbell, 1957) or have adjusted the height of the aid for

comfort (Wesmiller & H o h a n , 1994). in contrast, we standardized the height of the rollator

by using the approach most clinicians adopt when prescribing walking fiames (Pierson,

1994; Hall et al., 1990). Specifically, we ensured that the handle bars of the rollator were at

the level of the subject's ulnar styloid process (Pierson, 1994; Hall et al., 1990). It is possible

that the height of rollator may have been too low to facilitate the 'forward lean' position that

is thought to improve diaphragmatic f ic t ion and therefore optirnize the work of breathing in

individuals with COPD.

The complex interplay of physiological and psychological fac ton causing dyspnea

makes it difficult to evaluate (07Donnell, 1998; Ienkins et al., 1995; Breslin, 1992).

Although the sensation of dyspnea has been correlated with respiratory rate, minute

ventilation, accessory muscle recruitment and activity, chest wall asynchrony and emotional

statu, its rnechanisrns are not cornpietely understood in individuals with COPD (Lanon et

al., 1996; Breslin, 1992). Our finding of a decrease in the perception of dyspnea for al1

subjects but no change in any of the ventilatory variables is interesting. However, we did not

evaluate accessory muscle activity. It is possible that the reduction in perception of dyspnea

found with using the rollator may have been associated with a reduction in accessory muscle

activity and recmitment (Breslin, 1992; Breslin et al., 1990). It also is important to recognize

the multidirnensional nature of respiratory sensations that include not only sensory aspects

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but also affective and cognitive components (Altose, 1985). During exercise, an individual

may breathe very hard and not experience the sensation of dyspnea, because such exertion is

not accompanied by a sense of anxiety over the adequacy of ventilation (Shenvood, 1993).

The sensation of dyspnea may occur without a corresponding change in ventilation or gas

exchange (Sherwood, 1993).

This is the fint study to evaluate weight transfer with use of a rollator. We did not

find a significant relationship between amount of weight applied to the rollator and change in

functional exercise capacity (i.e. distance walked or perception of dyspnea). We can infer

Born this that the extent of improvement in functional exercise capacity with use of a rollator

is not dependent on the amount of weight applied to the rollator. However, this does not

preclude that the allowance of arm support provided by the rollator may have contributed to

the observed improvement. Specifically, it may have been the mere provision of support,

regardless of the arnount of weight transfer, that resulted in the improvement. The majority of

subjects (i.e. 60%) felt safer when using the rollator compared to without. It is possible that

the increased security provided by the support of the rollator contributed to the reduction in

the perception of breathlessness by decreasing fear and anxiety. Alterations in emotional

state can effect the cognitive processing of sensory information and perception of

breathlessness (Pandolf, 1983). The effect of am support on the perception of dyspnea has

not been reported previously.

Measures of gait (e.g. stride length) have been shown to be altered with training and

when using different types of wheeled w&ng aids (Bohannon, 1997; Mahoney et al., 1992;

McGavin et al., 1977). Mahoney and colleagues (1992) found that individuds waiked with

longer strides when using a three versus a two-wheeled walker. McGavin and colleagues

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(1977) found that mean stride length during a time-based waik

with training in men with COPD. They questioned whether this

test increased significantly

change was due to a more

efficient w a h g pattern. As such, we evaluated stride length to assess if this gross measure

of gait changed when using a rollator compared to without. Our finding no difference in

stride length suggests that gait alteration was not a rnechanisrn responsible for change in

fùnctional exercise capacity with use of a rollator.

We also considered whether use of a rollator would lead to change in walking speed.

Increases in walkîng distance with use of a wheeled walking aid in individuals with COPD

have been associated with reductions in walking speed (Grant & Capel, 1972). Likewise,

speed of walking has been shown to be altered when using different types of wheeled

walking aids (Cornely et al., 1997; Mahoney et al., 1992; Bohannon, 1977). Mahoney and

colleagues (1992) lound that older individuals walked faster with a three versus a two-

wheeled walker and Comely and colleagues (1997) found faster walking speeds associated

with use of a rollator versus a two-wheeled walker. Our findings suggest that change in

overall walking speed per se was not responsible for the observed change in functional

exercise capacity (Le. reduced breathlessness, reduced rest time and improved walk test

distance [subgmup only]) with use of a rollator. However, it did appear that use of the

rollator might have reduced minute to minute variability in distance waked during the six

minutes (Le. improved pacing), especially for those who walked less than 300 meters unaided

(Figure 3).

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4.5 Limitations -

There are several limitations to this study that must be considered. Due to the nature

of the study, the tester was not blinded. Lack of blinding may provide different

interpretations of marginal findings or differential encouragement during performance tests,

either one of which can distort results (Guyatt et al., 1993; Guyatt et al., 1984). To minimize

potential bias, data collection for the rnajority of rneasures (Le. six-minute walk test distance,

cardiorespiratory variables and gait measures) was automated. For those measures that were

manually collected (i.e. modified Borg ratings of dyspnea and leg discornfort, duration of

rest), a standardized protocol was followed. Likewise, the six-minute walk test was

administered in accordance with standardized instructions and no encouragement.

Although we gained insight into ventilatory changes with use of a rollator, these were

measured indirectly. Respiratory inductance plethysmography is a non-invasive technique

used to evaluate breathing volumes and pattern. The estimation of thoracic and abdominal

volumes contributing to each breath is based on measurement of the rib cage and abdominal

wall motion (Stromberg et al., 1993; Verschakelen et al., 1989; Stradling et al., 1985; Chadha

et al., 1982). Measurement of variables such as the synchrony of rib cage and abdominal

motion (Le. phase relationship of the thorax and abdomen to breathing) and minute volume

allow an indirect evaluation of diaphragmatic f ic t ion and work of breathing (Verschakelen

et al., 1989; Tobin et al., 1983). While direct assessments are possible (i.e. measuring

esophageal, gastric, intrapleural and transdiaphragmatic pressures using balloon or micro-

pressure transducer catheter systems passing through the nose), these measures are invasive

and often uncornfortable (Sanna et al., 1999; Gilbert et al., 1981; Sharp et al., 1980).

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We did not evaluate accessory muscle activity. Sharp and colleagues (1980)

suggested that accessory muscle activity might be optirnized when the arms are supported.

Additionally, increased accessory muscle use is believed to enhance dyspnea sensation

(O'Domell, 1995; Delgado et al., 1982; Sharp et al., 1977). Previous studies have evaluated

accessory muscle activity using electromyograms (EMG) via surface electrodes of the

stemocleidomastoid muscle (Martinez et al., 199 1 ; Sharp et al., 1980). However, the artefact

associated with EMG during comdor walking made it difficult to incorporate this measure

into the study.

The six-minute walk test was conducted in an artificial environment. In accordance

with recommendations in the literature, we administered the six-minute walk test in an indoor

corridor, free of distractions (Bittner, 1997). Furthermore, due to the nature of the study, data

collection necessitated the use of extraneous winng and equipment, not typically present in

day-to-day life. However, performance on the six-minute walk test has been found to be a

valid measure of functional exercise capacity in individuals with COPD (Table 3) and has

recently been show to closely parallel the level of activity that individuals are most likely to

perfom regularly in their daily lives (Steele et al., 2000).

Finally, the study descnbed in this thesis provides insight only into the short-terni

benefit of using a rollator. Individuals with COPD typically report a decrease in their

capacity to perfom routine activities of daily living due to symptoms of dyspnea and Fatigue

(Lareau et al., 1996). From the individual's perspective, the ability to remain active is ofien

the most important outcome of medical care (Deyo & Patrick, 1989). Although o w study

found an improvement in functional exercise capacity with use of a rollator, it remains

unknown whether the use of a rollator would facilitate an individual's ability to remain

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active, and prevent the deconditioning, worsening of symptoms and reduced quality of life

that often occurs with COPD (Canadian Respiratory Review Panel, 1998).

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Chapter 5: Conclusions and Recommendations for Future Research

5.1 Concludine Remarks - The aims of the study descnbed in this thesis were three-fold; fint, to determine the

short-term effect of using a rollator on functional exercise capacity in individuals with

COPD; second, to establish which individuals would benefit most ffom using a rollator; and

third, to provide insight into the underlying mechanisms that may contribute to change in

functional exercise capacity with use of a rollator. The results described herein provide

evidence that use of a rollator increases functional exercise capacity (Le. reduces

breathlessness and duration of rest required) in individuals with severe COPD. It was further

determined that individuals who walk less than 300 meters a d o r who require a rest during

an unaided six-minute walk test will benefit most (Le. reduction of breathlessness, reduction

in rest time and improvement in distance walked) fiom using a rollator. Finally, evidence

was provided that the improvement in functional exercise capacity observed with using a

rollator was not due to changes in breathing pattern or gait.

5.2 Future Research -

The study descnbed in this thesis has raised several additional questions related to the

use of a rollator in individuals with COPD and has pointed to further investigations that

would be needed to answer these questions. Recommendations for research include

conducting studies on the long-term use and effect of rollaton to establish whether they

contribute to sustained improvement in functional statu. Additionally, the effect of height of

the rollator on respiratory responses and functional outcomes remains unclear. hsight into

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the effect of a rollator on accessory muscle use would aiso be worthwhile. Finally, given the

beneficial effect of a rollator on functional exercise capacity for individuals most disabled by

COPD, a cornparison of the effect of a rollator to other interventions (e.g. supplemental

oxygen) warrants evaluation.

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Respitracem Instruction and Mormation Manual. Respitrace Corporation, Ardsley, New York., 1979.

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Tideiksaar R. Cornparison of a two-wheeled walker and a four-wheeled walker in a genatric population. Proceedings of the Annual Meeting of the Arnerican Geriatrics Society 1993: SA32, New Orleans.

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Wilson RC, Jones PW. A cornparison of the visual analogue scale and modified Borg scale for the measurement of dyspnea during exercise. Clinical Science 1989; 76: 277-282.

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Zeimetz GA, McNeill IF, Hall IR, Moss RF. Quantifiable changes in oxygen uptake, heart- rate and time to target heart-rate when hand support in allowed during treadmill exercise. Journal of Cardiopuimonary Rehabilitation 198s; 5: 525-530.

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APPENDIX 1

Eligibility Screening Form

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ROLLATOR STUDY ELIGIBILITY SCREENING FORM Contact: Sherra Solwav x4510

Subject Name:

1 . Diagnosis of COPD

2. Clinically Stable

3. 55-85 Years Old

4. Unaccustomed to Use of Rollator

5. Able to Walk Unaided

6. Able to communicate in English

If no, language spoken:

7. Coexisting symptomatic disease that contributes to exertional dyspnea or limits exercise ability/tolerance

If yes, speci fy:

ELIGIBLE?

Tel:

ELIGIBLE

- YES

- YES

- YES

- YES

- E S

- YES

INELIGIBLE

- - -- - - - -- -

Physician Name:

Physician Signature: Date:

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APPENDIX 2

Subject Information Sheet and Informed Consent Form

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Rollutor Study

Subject Lnforrnation Sheet

Contacts: S u n n a Mangovski Akamora (416-243-3600 x 2264) Dr. Dina Brooks & Sherra Solway (41 6-243-3600 ~ 4 5 1 0 )

Pur~ose of Studv: The purpose of this study is to compare the ability to walk and feelings of breathlessness with and without a rollator (wheeled walker) in individuals with chronic obstructive pulmonary disease.

Descri~tion of Studv: Participation in this study will involve simple tests of walkmg and a questionnaire sirnilar to those you have cornpleted as part of yow rehabilitation. In addition, a belt will be placed around your abdomen and chest cavity to rneasure your breathing. During the study, you will be asked to walk for six minutes with and without a rollator, on two separate days in the same week.

Benefits: There will be no direct benefit for participating in this study. However. the results of this study may benefit patients with chronic obstructive pulrnonary disease by helping health care professionals understand the effect of a rollator on shortness of breath and distance walked.

Potential Harm: There are no known physical, ernotional or social harms associated with participation.

Confidentialitv: Confidentiaiity will be respected and no information regarding your identity will be released or published without your consent. A copy of the results will be avaiiable to you if requested.

Pat-tici~ation: You rnay refuse to participate in ths study or withdraw fiom it at any time during its course. Your withdrawal will not jeopardize your relationship with West Park Hospital and will have no influence on your medical management.

Please c d Sherta Solway @ 41 6243-36OU ~ 4 5 1 0 ifyou have any questions or concem.

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Rollator Study

Informed Consent Form

1 have read the Subject Information Sheet. The research study and procedures have been explained to me and

any questions have been answered to my satisfaction. The potential harrns and discornforts have been explained

to me and 1 also understand the benefits to participating in this study. 1 know that I may ask now, or in the

future, any questions 1 have about the study or research procedures. 1 have been assured that records reiating to

my care will be kept confidential and no information will be released or printed that would disclose my personal

identity without my permission. 1 am aware of my option to refiise to participate in this study or to withdraw

from it at any time during its course. 1 understand that my withdrawal will not jeoprirdize my relationship with

West Park Hospital and will have no influence on my medical management.

Patient Name Signature Date

Investigator Signature Date

W i tness Signature Date

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APPENDK 3

Data Collection Form

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Age Weight

1 CR0 Score 1 Total: D: E: F: M: 1

Date:

Oxygen? Stage of Rehabilitation

No Y es Vmin for exertion

E ffort/Discomfort Scale BIood Pressure

Test 2: Rollutor: Y es No

Distance Walked # Rests Duration of Rests

Modified Borg Dyspnea Scaie Modified Borg Leg

Comments:

Pre-Test

Distance Walked # Rests Duration of Rests

Post-Tes t 7

Test 2: Rollator: Yes No

Comments:

f

Modified Borg Dyspaea Scale Modified Borg Leg E ffort/Discomfort Scale BIood Pressure

Pre-Test Pos t-Tes t

1

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Date:

[ BIood Pressure I I

Test 3: Rollator: Y es No

Distance Walked # Rests Duration of Rests

Comments:

Post-Test Modified Borg Dyspnea Scale Modified Borg Leg EfforüDiscomfort Scale

Pre-Tes t

Modifled Borg Dyspnea Scale Modified Borg Leg E ffort/Discomfort Scale

Test 4: Rollator: Y es No

[ Blood Pressure

Pre-Test

r

Distance Walked # Rests Duration of Rests

Post-Test

Comments:

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.MPENDIX 4

Modified Borg Scaie

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NOTHING AT ALL uust noticeable)

VERY VERY SLIGHT

VERY SLIGHT

SLIGHT

MODERATE

SOMEWHAT SEVERE

SEVERE

VERY SEVERE

VERY VERY SEVERE (aimost maximal)

MAXIMAL

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APPENDIX 5

Equations for Respiratory Inductance Plethysmography Calibration

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Calculation of calibration factors requires the solution of two simultaneous equations, each involving the rib cage, abdominal and standard measurements (Cohn et al., 1982; Chadha et al., 1982; Respitrace Manual, 1979).

General Formulas:

To Solve for x and y:

x = [(A'*v') - (A'*v')] I [(R'*A') - (R'*A')]

y = [(R'*v') - (R'*v')] / [(R'*A?) - (R'*A')]

Where:

x = calibration factor for rib cage

y = calibration factor for abdomen

A' = abdomen measurement at point 1

A' = abdomen measurement at point 2

R' = rib cage measurement at point 1

R' = rib cage measurement at point 2

V' = standard volume measurement at point 1

V' = standard volume measurement at point 2

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APPENDIX 6

Stride Sensor Output

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APPEN'DIX 7

Validation of Upper Extremity Weight-Bearing Sensing Mechanism

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1 1 1 I I 1 L I 1

O 2 4 6 8 10 12 14 16

True Weight (kg)

Figure II: Relationship between known weights applied to rollator and output of weight-bearing sensing mechanism. Solid line. calculated linear regression.

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APPENDIX 8

Su bject Preference Questionnaire

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Subiect Preference Ouestionnaire

Subject Name:

1. During the walk test, did you prefer to walk:

Cl with the rollator

a without the rollator

O no preference

2. Please CTRCLE your level of agreement with the following statements:

The rollator allowed me tu breathe easier ivhen I walked.

1 2 3 4 S trongIy Disagree Disagee Neither .4gree Agree

nor Disagree

The rollator made me feel safer when I walked.

1 2 3 Strongiy Disagree Disagree Neither Agree

nor Disagree

1 - 7 3 Strongly Disagree Disagree Neither Agree

nor Disagree

4 Agree

5 Strongiy Agree

5 Strongly Agree

5 Strongly Agree

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The rollator impaired m-v ability to walk.

1 - 3 3 Strongly Disagree Disagree Neither Agree

nor Disagree

3. Do you have any other comments about the rollator?

4 Agree

5 S trongly Agree

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APPENDIX 9

St. George's Respiratory Questionnaire

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This quest ionne is designed to help US leam much more about how your bnalhing is mubling you and how it affects your l i f ~ We are using it to find out which aspects of your illness cause you most problem. mthcr lhan what the doctors and nurses th0ink your problems

Pleare w d the inrtNction. carefully and ask if you do not understand any thing. Do not spend too long deciding about your answen

Sex: MaleFemate

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J 2 A R r l

]ESTIONS ABOW HOW MUCH CHEST TROUBLE YOU HAVE HAD OVER ?HE LAST YEAR

EASE TICK IN ONE BOX FûR EACH QUESTION.

most days a week

severai days a week O -

O

cl cl

a few days a week

only wirh c hes t

infections

cl

not at all

O

cl 0

. a

1) Over the last year. 1 have coughed:

2) Over the 1 s t year. 1 have brought l p phlegm (sputum) : 3 ) Over the last year, 1 have had jhortness of breath :

9 Over the last year. 1 have had amcks 3f wheering :

During the last year. how many severe or very unpleasant attackr of chest trouble have you had :

more than 3 attacks. ................... 3 attacks.. ............. .. ............... CI

2 atracks., CI

.............................. 1 attack.

O .................... /""""""

no attacks. cl

.............................. cl 1 How long did the wont attack of chest trouble last: i o LO Question 7 if you had no severe atucks)

a week or more. . . . . . . . .O. . . . . . . . . . . . , . 3 or more days

a .........................

1 or 2 days Q

............................. less than a day

cl ......................... C1

1 Over the last year. in an average wctk. how many good days vi th linle chest trouble) have you had:

no good 'days ........................... 1 or 2 good days..

O .....................

3 or 4 good days 0

....................... o nead y every day is good.. ............ O every day is good.. .................... cl

1 IE you have a wheem. is it worse in the morning: 1

no -....................................... Q yes.. ..................................... O

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. * U K U

m [OW wow YOU DESCRIBE YOUR CHEST C O N D ~ O N ? (PLEASE n a IN ONE BOX ONLY)

h e most important problem 1 have. ......... A.. ................................

causes me a few problems ...........................*............................. causes no problem.. ................................................................

= YOU HAVE EVER HAD PAID E M P L O Y M ~ , PLEASE TICK ONE OFTHESE: my chest trouble made me stop work ............................................

... my chest trouble interferes wilh my work or made me change my work ....................................... my chest trouble does not affect my work

N ?; QUESTIONS A B O m WHAT ACïNmES U S U W Y WUCE YOU FEEL BREATHIlESS I lESE

. . TRUE Sltting or lying srill. .............................................. Getting washed or dressed

O ......................................

Walking around the home.. O

..................................... Walking outside on the level..

CI ..................................

Walking up a flight of stairs -0

..................................... a Walking hills ...................................................... a a Playing sports or p m e s ......................................... cl a

E m O N 3 : SOME MORE QUESTIONS ADOüT YOUR COUGH AND BREATIUESSMSS y - ! E D AYS.

3R FACH TTEM, PLEASE TICK ElTHER TRUE OR FALSE AS ïï APPLIES TO YOU.

........................... ....................... My cough hum ;

My cough makes me tired ....................................... 1 am breathless when 1 talk ..................................... I am breathless when I bend over.. ..;. ... :. ................... My cough or breathing disturbs rny sleep.. ...................

. 1 get exhausted easily.. ..........................................

TRUE FALSE a cl O O c! cl CI D O a O O

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........... My cough or breathing is embarrassirtg in public. My chest trouble is a nuisance CO my family. friends or

....... ............................................... neig h bours ,.

- I get draid or panic when 1 cannot get my breath ............ 1 feel that I am not in control of my chest problern ...........

..................... I do not expect my chest to get any better

..... 1 have becorne fiail or an invalid because of my chest..

Exercise is not safe for me.. .................................... Everything seems too much of an effort .......................

TRUE O O

I G H ï TO SECTION 6. 3MPLE"iE TKIS SECIION PLEASE TICK EITHER ?RUE OR FALSE AS APPLEES TO YOU.

TRUE F U E My medication does not help me very much .................. cl cl 1 ger embarrasxd using my medication in public ............ I have unpleasant side effects from my medication

a 0 ...........

My medication interferes with my life a lot.. cl cl.

................. / 11 Q

n O N 6 : THESE ARE QUESTïONS ABOUT HOW YOUR ACTIVITIES MIGKT BE BY YOUR

ATHING. TiCK

EACH QUESTiON, PLEASE~RUE IF ONE OR MORE PARTS APPLES TO YOU BECAUSE OF YO- - - -

1 uke a long time to get washed or dressed ................... I cnnnot take a bath or shower. or 1 wke a long time ......... 1 walk slower than other people. or 1 stop for rests .......... Jobs such as housework take a long tikc or 1 have to stop

............................................................ for rests If 1 walk up one flight of staiis. 1 have to go slowly or

C stop.*. .**.- ......................................................... If 1 hurry or walk fast. 1 have to stop or s low

- down ........-...... ... ........................................... My brealhing rnakes ir difficult to do things such as walk up hills. carrying things up stairs. light gardening such as

..................... weeding. dance. play bowls or play golf

h ë w y loads.dig the garde* or shovel snow. jog or waiic i t 0 ....................... 5 miles per hour. play tennis or swim ..

My breahing makci it difficult to do things nich as very hcavy manual work. run. cycle. swim fast or olav a ~ f i m n a p : ~ : r . . r - - - - - -

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E. .EASE TiCK EITHER TRLTE OR FALSE AS IT' APl'UES TO YOU OF YO-.T

EMEMBER 'IHAT TRUE ONLY APPL~ES TO YOU t~ YOU CAN NOT w SOMFIHING BECAUSE OF YOUR

LIRUE ... ............................ I cannot play sports or games. ;..

1 cannot go out for entenainment or recreation. cl

............... 1 cannot go out of the house to do the shopping..

cl ............ cl

.......................................... I cannot do housework 5 1 cannot move far [rom my bed or chair. ...................... O

ERE IS A LIST OF OTHER ACITVXES THAT YOUR CHESI' 'IROUBU MAY PRRrENT YOU WING. (YOU DO

OT HAVE TQ TICK THESE, TKEY ARE JUST TO REMIND YOU OF WAYS IN - WHICH YOUR B-THLESSNESS

[AY AFFECT YOU) :

GONG FOR WALKS OR WALKING THE DOG

DONG THINGS AT HOME OR IN THE GARDEN

SEMJAL NIERCOURSE

GOING OUT TO CHURCH, OR PLACE OF ENTERTADIMENT

GûING OUT IN BAD WEATHER OR SMOKY ROOMS /'

'LEME WRITE Dl ANY OTHER IMPORTANT

~OW. W O U YOU Ti= INTHE BOX (ONE ONLY) WWCH YOU 'IHTMC BEST DESCRïBES HOW YOUR :HEST AFFErn YOU:

It does not stop me doing anything 1 would like to do ....... Q a

...... It stops me doing one or two things I woÜld like to do 0

..... Ir stops me doing most of the things 1 would like to do a . Il stops me doing everything I would like to do.. ............ a -

HAMC YOU FOR FILLING IN THIS QUESTiONNAIRE. BEFORE YOU =SH WOULD YOU HECK TO SEE ?HAT YOU HAVE ANSWERED ALL TKE QWTIONS.

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APPENDU 10

Calculation Procedure for Phase Angles

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I+bdomeq

R ; b Caye

Phase Angle = (B - A) /(C - A) r 360 degrees

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APPENDLX 11

Normal Respiratory Data

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RESPIRATORY RATE

Normal I

Post Test 1 13.5 14

MINUTE Pre Test

1

6 Minute Average 1 13.3 11.8 - -- '.. - -

Normal 2 1 MINUTE 1 NO ROLLATOR 1 ROLLATOR 1

NO ROLLATOR 15.5 15.5

II Pre Test 1 15.5 1 17 II

ROLLATOR 16 13

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Normal 3 MINUTE Pre Test

- -. . . - .

E = unable to determine due to poor quality of data

NO ROLLATOR 1 ROLLATOR 21 E

2 3 4 5 6

Post Test 6 Minute Average

- --

25 25 28

26.5 26

20.5 25.9

Normal 4

25 26

25.5 25 28

23.5 25.3

MINUTE Pre Test

1 2 3 4 5 6

Post Test

3 e E = unabIe to determine due to poor quaIity of data

NO ROLLATOR 16.5 E E E E E 30 25 E

ROLLATOR 16.5 24

25.5 24.5 23 -5 25 27

23.5 24.9

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PHASE RELATIONSHIP OF N B CAGE AND ABDOMINAL MOTION

Normal 2

Normal 2

MINUTE Pre Test

I 2 3 20.2 degrees 38.8 degees 4 E 1 8 .O degrees 5 0.0 degrees 33.4 degrees 6 0.0 degrees 39.5 degrees

E = unable to determine due to poor quality of data

NO ROLLATOR 0.0 degrees 0.0 degrees 0.0 degrees

ROLLATOR 0.0 degrees 0.0 degrees 26.9 degrees

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Normal 3

Normal 4

E = unable to determine due to p o t quality of data

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Normal I

II Post Test 1 8.9L 1 9.2L II

MINUTE

6 Minute Average 14.OL 1 13.8L II

Normal 2

Pre Test 1 0.4L 9.0L ,

NO ROLLATOR ROLLATOR

II Post Test 1 3,OL 1 13.4L II

MINUTE Pre Test

NO ROLLATOR 6.8L

ROLLATOR 9.6L

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Normal 3

MINUTE Pre Test

Normal 4

I Post Test 6 Minute Average

MINUTE NO ROLLATOR ROLLATOR Pre Test 8.8L 8.2L

NO ROLLATOR 9.3L

Post Test 1 12.9L 1

ROLLATOR E

E = unable to determine due to poor quality of data

12.2L 16.2L

6 Minute Average 1 E 18.8L n

E = unable to detennine due to poor quality of data

15.6L 18.9L

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RELATIVE CONTRIBUTION OF RIB CAGE (RC) AND ABDOMEN (A) (RC/A RGTIO)

Normal I iWNUTE NO ROLLATOR 1 ROLLATOR Pre Test 0.62 1.24

1 0.58 1 0.97

6 0.50 O. 72 Post Test 0.77 0.94

II 6 Minute Averaee 1 0.53 1 0.92

Normal 2 11 MINUTE 1 NO ROLLATOR 1 ROLLATOR II

II Post Test 1 1.01 1 0.93 II

Pre Test 1 2 3

1.37 1.35 1.55 1 .O2

1.14 1.70 1.69 1.72

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Normal 3

E = unable to detexmine due to poor quality of data

MINUTE Pre Test

Normal 4

NO ROLLATOR 3.28

Post Test 1 3.33 1 3.97 II

ROLLATOR E

MINUTE Pre Test

E = unable to determine due to poor quality of data

NO ROLLATOR ROLLATOR 1.80 1 5.49