Early Aerobic Exercise Intervention After Stroke ... Aerobic Exercise Intervention After Stroke: Improving Aerobic and Walking Capacity by Jake Jangjin Yoon A thesis submitted in conformity
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Early Aerobic Exercise Intervention After Stroke:
Improving Aerobic and Walking Capacity
by
Jake Jangjin Yoon
A thesis submitted in conformity with the requirements
Jake Jang Jin Yoon Advisor: Master of Science, 2009 Dr. Dina Brooks Graduate Department of Rehabilitation Science University of Toronto
The benefits of brief-duration, early exercise programs in stroke have been shown, but the
effects of longer-duration aerobic training early after stroke have not been examined. The
purpose of this study was to determine the effects of an early aerobic exercise program that
extended beyond inpatient into outpatient rehabilitation on aerobic capacity, walking
parameters (walking distance, speed, and symmetry), health-related quality of life, and
balance. Patients in the subacute phase after stroke (n = 15) with mild to moderate
impairment received aerobic exercise in addition to conventional rehabilitation. The study
participants demonstrated significant improvement in aerobic and walking capacity, peak
work rate, quality of life, balance, and gait velocity from baseline to midpoint. However,
no difference was found between midpoint and final. This early aerobic exercise program
following stroke significantly improved aerobic capacity, walking ability, quality of life
and balance during the inpatient period although no further improvement was observed
during the outpatient period.
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Acknowledgements
First of all, I would like to thank my supervisor, Dr. Dina Brooks, for her ongoing support throughout my study. My thesis would not have been possible to complete without your guidance, and you are one of the most influential people who made my graduate experience fun and memorable. I cannot express my gratitude enough to you and I feel extremely lucky to have you as my supervisor. I would also like to thank Dr. Bill McIlroy for his guidance and patience. He has guided me through my graduate studies along with Dina when I felt overwhelmed with many questions. He is also one of the reasons why my graduate experience has been such a enjoyable experience. You have been such a great leader and a great mentor, and it has been my honour to work with you. I am grateful to Dr. Scott Thomas for his guidance and feedback. You have taught me how to think critically and made me become better at research. I would like to thank everyone at the Mobility Team for their support, especially Hannah Cheung, Sanjay Prajapati, Bimal Lakhani, and Ada Tang for their wisdom and laughter. I thank everyone at Toronto Rehab who made this work possible including Lou Biasin, Janice Komar, Jackie Lymburner, Chris Peppiatt, Dr. Mark Bayley, Dr. Denise Richardson, Dr. Lisa Becker, and all the study participants. Finally, I would like to thank my family and friends for their unconditional support and love. I truly believe that I would not have accomplished many of my goals if I did not have their support and belief in my ability. You are the source of my inspiration and drive to excel in what I do. Thank you. I am extremely fortunate to be surrounded by many inspirational and supportive people, and I sincerely apologize to you if I have missed you here. But, I am truly grateful to all of you who have guided and supported me.
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Table of Contents
Abstract ii
Acknowledgements iii
Table of Contents iv
List of Tables vi
List of Figures vii
Abbreviations viii
1.0 Introduction 1
2.0 Background 5
2.1 Epidemiology of Stroke 5
2.2 Stroke Risk Factors 5
2.3 Impairments and Disabilities Following Stroke 7
Improvements in physical function and control during training and testing sessions also
has the potential to increase psychological gains following exercise programs (Teixeira-
Salmela et al., 1999).
15
Table 1. Summary of literature: effects of aerobic training in chronic stroke
Study Design Population Time since
stroke
Duration / Intensity Intervention Outcome
Measures Findings/Author's
Conclusions
Ada et al., 2003
Randomized, placebo-controlled clinical trial with 3-month follow-up
N = 27 (19M; 8F) Mean age = 66
6months to 5 years
4weeks; 3x/week; 30min/session
E: Both treadmill and overground walking with proportion of treadmill walking decreasing by 10% each week; C: Low-intensity, home exercise program to lengthen lower limb muscles and to train balance and coordination.
Walking speed (over 10m), walking capacity (distance over 6min), and handicap (stroke-adapted 30-item version of the Sickness Impact Profile).
The 4-week treadmill and overground walking program significantly increased walking speed and walking capacity, but did not decrease handicap. These gains were largely maintained 3 months after the cessation of training.
Chu et al., 2004
Single-blind randomized controlled trial
N = 12 (11M; 1F) Mean age = 61.9 (Exercise); 63.4 (Control)
> 1 year 8 weeks; 3x/week; 60min/session
E: Water-based exercise program focusing on leg exercise to improve cardiovascular fitness and gait speed; C: Arm and hand exercises while sitting.
Exercise group significantly improved cardiovascular fitness, maximal workload, gait speed, and paretic lower-extremity muscle strength.
Dean et al., 2000
Randomized, controlled pilot study with 2-month follow-up
N = 12 (3 people withdrew; 9 people completed the study) (7M; 6F) Mean age = 66.2 (Exercise); 62.3 (Control)
>3months 4 weeks; 3x/week; 60min/session
E: Circuit program designed to strengthen muscles in the affected leg and practicing locomotion-related task; C: Similar to exercise group, except it was designed to improve the affected upper limb.
Gait speed, walking distance, timed up and go, sit to stand, and step test.
Task-related circuit training improved walking distance, gait speed, affected leg force production, and the number of repetitions of the step test.
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Study Design Population Time since
stroke
Duration / Intensity Intervention Outcome
Measures Findings/Author's
Conclusions
Lee et al., 2008
Randomized controlled trial
N = 52 (28M, 20F) Mean age = 63.2
>3months 10-12 weeks; 3x/week; 60min/session
E1: aerobic cycling plus sham progressive resistance training (PRT); E2: sham cycling plus PRT; E3: aerobic cycling plus PRT; C: sham cycling plus sham PRT.
6-minute walk distance, habitual and fast gait velocities, and stair climbing power, cardiorespiratory fitness, muscle strength, power, endurance, psychosocial attributes.
No significant differences between groups on walking distance, gait velocity. PRT group significantly improved stair climbing power, muscle strength, power, muscle endurance, cycling peak power output, and self-efficacy; Aerobic training group improved indicators of cardiorespiratory fitness. Cycling plus PRT produced larger effects than either single modality for mobility and impairment outcomes.
Lennon et al., 2008
Single-blinded Randomized controlled trial
N = 48 (28M; 20F) Mean age = 60.5 (control), 59.0 (Exercise)
> 1 year 10 weeks; 2x/week; 30min/session
E: Usual care plus cycle ergometry aerobic exercise C: Usual care.
Cardiac risk score (CRS), VO2, Borg Rate of Perceived Exertion (RPE), Hospital Anxiety and Depression Scale (HADS), Frenchay Activity Index, fasting lipid profiles, and resting blood pressure.
Preliminary findings suggest non-acute ischemic stroke patients can improve their cardiovascular fitness and self-reported depression and reduce their CRS with a cardiac rehabilitation program.
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Study Design Population Time since
stroke
Duration / Intensity Intervention Outcome
Measures Findings/Author's
Conclusions
Luft et al., 2008
Randomized controlled trial
N = 71 (33M; 38F) Mean age = 63.2 (Exercise); 63.6 (Control)
Group 1: 8 weeks of aerobic training using a recumbent cross trainer (NuStep) followed by 8 weeks of home exercise program(HEP); Group 2: same as Group 1 but in opposite order.
Lower extremity scale of the Fugl-Meyer and the Berg Balance Scale.
HEP participation showed no changes on any of the outcome measures while NuStep participation improved Fugl-Meyer and Berg Balance scores.
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Study Design Population Time since
stroke
Duration / Intensity Intervention Outcome
Measures Findings/Author's
Conclusions
Pang et al., 2005
Randomized controlled trial
N = 63 E: 19M,13F, Mean age = 65.8; C: 18M, 13F, Mean age = 64.7
> 1 year 19 weeks; 3x/week; 60min/session
E: Progressive fitness and mobility and mobility exercise program targeting cardiorespiratory fitness, balance, leg muscle, strength,mobility, and hip bone mineral density (BMD); C: Seated upper-extremity program.
Maximal oxygen consumption, 6-minute walk test, isometric knee extension, Berg Balance Scale, Physical Activity Scale for Individuals with Physical Disabilities, and femoral neck BMD.
The intervention group had significantly more gains in cardiorespiratory fitness, mobility, and paretic leg muscle strength than controls. Femoral neck BMD of the paretic leg was maintained in the intervention group, but significantly declined in controls.
Pohl et al., 2002
Randomized controlled trial
N = 60 (3 groups ; N = 20/group; Group1: 13M/7F, Group2: 14M/6F, Group3: 16M/4F) Mean age = 61.6 (Gr1), 57.1 (Gr2), 58.2 (Gr3)
> 4weeks 4 weeks; 3x/week; 30min/session
E1: Conventional physiotherapy plus limited progressive treadmill training (LTT); E2: Conventional physiotherapy plus structured speed-dependent treadmill training (STT); C: Conventional physical therapy gait training (CGT).
VO2peak, heart rate, workload, exercise time, resting and submaximal blood pressure, and sensorimotor function.
Only experimental subjects showed significant improvement in maximal oxygen consumption, workload, and exercise time. Improvement in sensorimotor function was significantly related to the improvement in aerobic capacity.
Rimmer et al., 2000
Randomized pretest/posttest lag control group
N = 35 (9M, 26F) Mean age = 53.2
> 6months Two 12-week iterations; 3x/week; 60min/session
Peak VO2, maximal workload, time to exhaustion, 10RM on two LifeFitness strength machines, grip strength, body weight, total skinfolds, waist to hip ratio, hamstring/low back flexibility, shoulder flexibility.
The exercise group showed significant gains in peak VO2, strength, hamstring/low back flexibility, and body composition. No significance found on waist to hip ratio, shoulder flexibility, and grip strength.
Teixeira-Salmela et al., 1999
A randomized pretest and posttest control group, followed by a single-group pretest and posttest design.
N = 13 (7M, 6F) Mean age = 67.73
> 9months 10 weeks; 3x/week; 60-90 min/session
E: Program consisting of a warm-up, aerobic exercises (10-20min of TM walking, stepping or cycling at 70% HRpeak), lower extremity muscle strengthening, and a cool down; C: No intervention.
Muscle strength and tone, level of physical activity, quality of life, gait speed.
Significant improvements were found for all the selected outcome measures (level of physical activity, quality of life, and gait speed) for the treatment group.
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2.5 Aerobic Training in Subacute Stroke Population
Several studies have shown that early aerobic exercise following stroke is safe, and
stroke-related impairments at the subacute stroke stage might be improved by such
exercise (da Cunha et al., 2002; Tang, Sibley, Thomas, Bayley, Richardson, McIlroy, &
Brooks, 2009). However, there are still insufficient data to guide clinical practice, and
mixed findings in the literature necessitate further studies. In a previous study from our
group, we evaluated the feasibility of adding aerobic training to conventional
rehabilitation early after stroke (Tang, Sibley, Thomas, Bayley, Richardson, McIlroy, &
Brooks, 2009). Twenty-three patients in the subacute phase after stroke underwent 30
minutes of aerobic cycle ergometer training 3 days/week until discharge from a rehab
centre. Findings from our previous study showed a trend towards greater improvements
in functional outcomes, and we concluded that early aerobic training could be safely
implemented to conventional stroke rehabilitation without deleterious effects.
Moreover, stroke-related impairments in the subacute stroke population may be reduced
effectively by implementing aerobic exercise programs early after stroke. It is during the
first few months following stroke that the most spontaneous recovery takes place (Cramer
2008). Recent evidence from animal literature further supports the importance of early
exercise by demonstrating heightened responsiveness to rehabilitative experiences early
after stroke which declines with time (Biernaskie, Chernenko, & Corbett, 2004). Early
after stroke, patients may be more motivated to participate in rehabilitation programs and
willing to adopt an exercise program as their life-long habit. A combination of all these
factors emphasizes the importance of early exercise. Despite the potential benefits
associated with early aerobic exercise, only a handful number of studies have
investigated the effects of aerobic exercise programs in the sub-acute stroke population
and reported mixed results (see Table 2). The lack of consensus on benefits of aerobic
exercise in this population calls for further trials.
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Table 2. Summary of literature: effects of aerobic training in sub-acute stroke
Study Design Population Time since
stroke
Duration / Intensity Intervention Outcome
Measures Findings/Author's
Conclusions
Duncan et al, 1998
Randomized controlled pilot study
N = 20 Mean age = 67.8 (control), 67.3 (experimental)
30-90 days
12 weeks; 3 days/week; 90 min/session
E: performed exercise program, designed to improve strength, balance, and endurance and to encourage more use of the affected extremity. C: Usual care provided
Fugl-Meyer Motor Assessment, the Barthel Index of Activities of Daily Living (ADL), the Lawton Scale of Instrumental ADL, the Medical Outcomes Study–36 Health Status Measurement, 10-m walk, 6-Minute Walk, the Berg Balance Scale, and Jebsen Test of Hand Function.
Experimental group showed significant improvements only in Fugl-Meyer Lower Extremity score and gait velocity. No significant differences were observed in other measures.
Duncan et al, 2003
Randomized controlled single-blind clinical trial
N = 92 (50M, 42F) Mean age = 70
30 to 150 days
12-14 weeks; 36 sessions; 90 min/session
E: Various exercises targeting flexibility, strength, balance, endurance, and upper-extremity function were prescribed. C: Usual care provided
strength, balance, motor control, mobility, peak aerobic capacity, upper-extremity function and endurance
There were trends toward greater gains in strength and motor control in the intervention compared with the usual care group, but the differences were not significant. The intervention group showed significant improvments in balance, endurance, peak aerobic capacity, and mobility.
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Study Design Population Time since
stroke
Duration / Intensity Intervention Outcome
Measures Findings/Author's
Conclusions
Eich et al, 2003
Randomized controlled trial
N = 49 (Group A, 17 M, 8 F; Group B, 16 M, 9 F) Mean age = 62.4 (Group A), 64 (Group B)
<6 weeks
6 weeks; 5 days/week; 60 min/session
E: 30 minutes of treadmill training with increasing speed and incline and 30 minutes of physiotherapy; C: 60 minutes of physiotherapy
Walking velocity, distance (capacity), walking ability and walking quality
Walking velocity and walking distance improved significantly in the experimental group.
Katz-Leurer et al, 2003
Randomized controlled trial
N = 92 (50M, 42F) Mean age = 63.3
<30 days 8 weeks; Part 1, 5 days/week, 2 weeks; 20 min/session; Part 2, 3 days/week, 6 weeks; 30 min/session
E: Individualized exercise program using the leg cycle ergometer C: no intervention
Workload, exercise time, resting and submaximal blood pressure and heart rate, and walking distance and speed
A trend of improvement between groups was found in all parameters in favor of the experimental group, but only heart rate at rest, workload, and stress test stage reached a significant level.
Studenski et al, 2005
Secondary analysis of a single blind RCT
N = 93 (50 M, 43 F) Mean age = 69.5
30-150 days
12 weeks; 36 sessions
E: Various balance, stretching, strengthening, and aerobic training exercises were prescribed; C: Usual care provided
Functional Independence Measure, Barthel index, Lawton and Brody instrumental ADL, gait speed thresholds (0.8 m/s) for community ambulation,Stroke Impact Scale and the Medical Outcomes Study SF36 questionnaire
The intervention group improved significantly in SF-36 social function and in SIS (strength, emotion, social participation, and physical function). However, there were no significant improvements in Barthel score, SF-36 (physical function, physical role function, and SIS upper extremity function.
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Study Design Population Time since
stroke
Duration / Intensity Intervention Outcome
Measures Findings/Author's
Conclusions
Tang et al, 2009
Prospective matched control design
N = 23 (experimental), 22 (control) (12 M, 11 F, experimental; 11 M, 7 F, control) Mean age = 64.7 (experimental), 65.7 (control)
<3 months
4-5 weeks; 3 days/week; 30 min/session
E: Regular treatment plus aerobic training C: Received regular treatment
VO2 peak, peak HR, peak WR, gait speed and symmetry, functional ambulation (6MWT) and health-related quality of life.
Both groups demonstrated improvements over time in most of the aerobic outcomes. There were no group–time interaction effects but there were trends toward greater improvement in the Exercise compared with the Control group.
Teixeira da Cunha Filho et al, 2001
Randomized controlled trial
N = 12 (12 M) Mean age = 57.83 (experimental), 59.67 (control)
<6 weeks
2-3 weeks; 5 days/week; 20 min/session
E: Received regular rehab plus supported treadmill ambulations training (STAT). C: Received regular rehab care.
Oxygen consumption, heart rate, workload, and time
STAT group significantly improved oxygen consumption, but no significant improvements were seen in total workload, and total time pedaling the bike.
Teixeira da Cunha Filho et al, 2002
Randomized controlled trial
N = 12 (12 M) Mean age = 57.83 (experimental), 59.67 (control)
<6 weeks
3 weeks; 5 days/week; 20 min/session
E: Received regular rehab plus supported treadmill ambulations training (STAT). C: Received regular rehab care.
Gait ability, gait speed, walking distance, gait energy expenditure, gait energy cost
No significant differences in any of the variables
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2.6 Aerobic Exercise and Conventional Stroke Rehabilitation
Despite the high prevalence of deconditioning among individuals after stroke,
conventional stroke rehabilitation has given limited attention to the benefits of aerobic
training on stroke recovery. MacKay-Lyons and Makrides have demonstrated that
patients with stroke spent an average of 2.8 minutes in their aerobic exercise target heart
rate zone during physical therapy over the course of stroke rehabilitation, representing
only 4.8% of the time spent in physical therapy (MacKay-Lyons & Makrides, 2002). The
lack of aerobic exercise components in conventional stroke rehabilitation may stem from
the view that stroke recovery is dependent on the state of the neuromuscular system
imposed by upper motor neuron damage (MacKay-Lyons & Howlett, 2005). The static
nature of conventional stroke rehabilitation programs might contribute to the low
physical endurance of poststroke patients (Hjeltnes, 1982). Also, other reasons for not
systematically addressing cardiovascular issues in stroke rehabilitation may include
increased risk of falls, worsening of spasticity, and negative cardiac response to the
potential overwork necessary to achieve a training effect; however, such concerns have
not been supported (Bateman et al., 2001; Macko et al., 2001).
2.7 Research Rationale and Objective
Previously, we have demonstrated that it is feasible to add aerobic cycle ergometer
training to conventional rehabilitation early after stroke (Tang, Sibley, Thomas, Bayley,
Richardson, McIlroy, & Brooks, 2009). We also reported improvements over time with a
trend toward greater aerobic benefit on walking and aerobic capacity in the Exercise
group, compared to the Control group. Despite the greater improvements shown in the
Exercise group, the differences between the groups were not significant. We suggested
that the insignificant results may be attributed to the short training duration (2-4 weeks of
training during inpatient rehabilitation), and a longer period of training beyond inpatient
rehab would likely contribute to greater benefits. Thus, the objective of this study was to
examine the effects of an early aerobic exercise program following stroke that extended
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beyond inpatient into outpatient rehabilitation on aerobic capacity, walking parameters
(walking distance, speed, and symmetry), health-related quality of life, and balance.
2.8 Hypothesis
The study hypothesis was that an early aerobic exercise program following stroke that
extended beyond inpatient into outpatient rehabilitation would significantly improve
aerobic capacity, walking parameters (walking distance, speed, and symmetry), health-
related quality of life, and balance throughout the inpatient and outpatient training period.
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Chapter 3
3.0 Methods
3.1 Participants
This study was approved by the Research Ethics Boards at the University of Toronto and
the Toronto Rehabilitation Institute (TRI) (REB# 03-092). Upon admission to TRI,
patients with hemorrhagic or ischemic stroke were screened for study eligibility from the
in-patient stroke rehabilitation unit. The following study criteria (see Table 3) were used
for the screening process:
Table 3. Participant eligibility criteria
Inclusion criteria • Chedoke-McMaster Stroke Assessment (CMSA) Leg Score between 3 and 6 • Ability to understand the process and instructions for exercise training • Ability to provide informed consent
Exclusion criteria • Resting blood pressure greater than 160/100 despite medication • Other cardiovascular morbidity which would limit exercise tolerance (heart failure, abnormal blood pressure responses or ST-segment depression > 2mm, symptomatic aortic stenosis, complex arrhythmias) • Unstable angina • Orthostatic blood pressure decrease of >20 mmHg with symptoms • Hypertropic cardiomyopathy • Other musculoskeletal impairments which would limit the patient’s ability to cycle • Pain which would preclude participation • Greater than 3 months post stroke
3.2 Measurements
Once consented, participants entered the study and underwent assessments at three
prescribed measurement points: baseline, midpoint, and final. When the participants
followed the prescribed timeline, baseline measures were obtained upon recruitment into
the study during inpatient rehabilitation. Midpoint measures were obtained just prior to
discharge from inpatient rehabilitation program at TRI. The participants continued to
exercise in an outpatient setting, and final measures were taken after about 6 – 8 weeks of
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training in the outpatient setting. Many participants had 1-2 weeks of a transition period
from inpatient to outpatient programs because of waiting list and scheduling issues and
during this time, most of the subjects did not exercise. The time lost during the transition
period was added to their training program in order to make the number of training weeks
to be approximately 12 weeks. For example, if a participant trained for 4 weeks as an
inpatient and there was a 2 week transition period, she trained 8 more weeks, staying in
the program for 14 weeks to make up for the 2 week transition period. Figure 1
demonstrates study timelines.
4 - 6 wks 6 – 8 wks
Admission
In-patient Stroke Rehabilitation, Toronto Rehabilitation Institute
Out-patient Stroke Rehabilitation, Toronto Rehabilitation Institute
Admission Assessment
Intervention Period
Discharge Assessment
Discharge from hospital
Discharge from study
Intervention Period
Discharge Assessment
TransitionPeriod
1 – 2 wks
Figure 1. Study timeline summary
Before baseline measures were performed, participant characteristics were recorded from
hospital medical charts which included birth date, gender, past medical history and co-
morbid conditions, and their stroke-related information including lesion type, location,
and current medication.
There were four participants who did not follow this prescribed timeline. Even though
two participants (SA05 and SA31) entered the study as inpatients, they both were
discharged from TRI without any inpatient training soon after being recruited into the
study. Hence, they were treated as if they were recruited as outpatients and their midpoint
assessments were taken after approximately 7-8 weeks of training in their outpatient
training. Another two participants (SA28 and SA32) started as inpatients, but because
they only underwent a few training sessions before being discharged from TRI, their
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midpoint measures were not taken at discharge from TRI but rather obtained during their
outpatient rehabilitation periods.
Primary Measurements
Graded Maximal Exercise Test (max test)
A graded maximal exercise test was administered to measure peak oxygen consumption
of participants on a BiodexTM semi-recumbent cycle ergometer. The participants
underwent four maximal exercise tests throughout the course of study: two during
baseline measures, one during midpoint measures, and one during final measures. Two
tests were conducted during baseline measures to eliminate trial-to-trial practice effects
(Tang, Sibley, Thomas, McIlroy, & Brooks, 2006), and they were separated by at least
one day to provide participants with sufficient time to recover from the first test. In the
course of the study, a max test and a training session were also separated by at least one
day to allow the participants enough time to rest after the training session. During the
test, they were asked to pedal at a target rate of 50 revolutions per minute (RPM), which
does not aggravate inappropriate muscle activities (Brown & Kautz, 1998). If they felt 50
RPM was too slow, they were allowed to pedal faster up to 60RPM. The test protocol
began with two minutes of pedaling with the least resistance (10W) as a warm-up,
followed by a progressive increase in resistance. The increment of resistance was
estimated from the first exercise test, so that a total test time would be 8-10 minutes for
each participant. The test was terminated according to American College Sports Medicine
guidelines (American College of Sports Medicine, 2006), or if participants were unable to
maintain pedaling at their target rate.
A MOXUSTM Metabolic Cart was used to measure peak oxygen consumption (VO2peak)
and respiratory exchange ratio (RER). If RER of less than 0.85 was achieved during a
max test, VO2peak obtained during this test was not considered to be accurate and was
discarded. VO2peak with a higher RER was used for baseline since two max tests were
conducted. Peak VO2, peak RER, peak work rate (WRpeak), and peak heart rate
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(HRpeak) were also obtained during the test. HR was monitored continuously with a
PolarTM Heart Rate monitor. To ensure the safety of participants, blood pressure (BP) was
measured using an automated system (TangoTM) at rest and throughout the test, and
cardiac electric activity was monitored using a 5-lead electrocardiogram for any
abnormalities (e.g. ST depression). Participants were also asked for their Rating of
Perceived Exertion (RPE) throughout the test for overall body and for only legs, using a
modified Borg scale (0 – 10).
Six-Minute-Walk-Test (6MWT)
For the ambulatory participants who were able to walk at least ten meters independently
regardless of the use of any walking aids, Six-Minute Walk Test (6MWT) was
administered to assess their functional ambulation (Solway, Brooks, Lacasse, & Thomas,
2001). The main outcome of the test was Six-minute walk distance (6MWD). Before the
test, standardized instructions (American Thoracic Society, 2002) were given to the study
participants, and they were asked to walk as far as possible over a 30-meter course within
6 minutes. No encouragement was provided during the test. HR and RPE were noted
before and at the end of the test. If the participants used any walking aids, they were
allowed to use them and the type of walking aid was also noted. Two 6MWTs were
administered at baseline to minimize any practice trial effects (Solway et al., 2001).
Non-ambulatory participants were accounted for in two ways: 1) given a score of zero or
2) excluded from the analysis.
Secondary Measurements
Stroke Impact Scale Questionnaire
The Stroke Impact Scale (SIS) questionnaire was administered to measure stroke specific
impairments and quality of life. The SIS is a self-reported questionnaire which integrates
various dimensions of function and health-related quality of life (Lai, Studenski, Duncan,
& Perera, 2002). It contains 59 questions in 8 domains (strength, memory and thinking,
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emotion, communication, activities of daily living (ADL), mobility, hand function, and
social participation). The SIS has been shown to be valid, reliable, and sensitive to
change in individuals in the early phase of stroke (Duncan et al., 1999). For the purpose
of this study, only 4 physical domains (strength, ADL, mobility, and hand function) were
included in the study analysis, and scores were converted to a percentage.
Berg Balance Scale (BBS)
The Berg Balance Scale (BBS) was utilized as a measure of balance in the study
participants. The BBS consists of 14 tasks that are scored on a scale of 0 to 4. The tasks
range from simple balance tests (e.g. standing unsupported, transfer, etc) to more
challenging tests (turning 360 degrees within 4 seconds, tandem standing, etc). A score of
0 was given to the participant who was unable to do the task, and a score of 4 was given
to the participant who could complete the task according to its criterion. The maximum
score on the test is 56.
Gait Assessments
A 5 meter-long pressure-sensitive mat (GaitRiteTM, CIR Systems, Clifton, NJ) was used
to measure gait velocity and symmetry. Study participants were asked to walk across the
mat for a total of 6 times (3 times at their preferred walking speed and 3 times at their
fastest walking speed). They were allowed to use any walking aids if required. An
average of the 3 runs was used to calculate gait velocity (cm/s) and between-limb
temporal symmetry ratio. The temporal symmetry ratio (Patterson et al., 2008) was
A resulting ratio of between-limb temporal symmetry greater than 1.0 indicated
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a preference to rely on the nonparetic limb during walking. However, for statistical
purpose, the limb with the larger swing-stance time ratio was chosen as a numerator
while the limb with the smaller ratio became a denominator. This resulted in a ratio equal
to or greater than 1.0. Thus, any asymmetry would have a ratio greater than 1.0,
regardless of the direction of asymmetry. Although no information on the direction of
asymmetry was obtained via this adjustment, it eliminated the possibility of errors in
statistical analysis. A score greater than 1.12 was considered as asymmetrical gait
(Patterson et al., 2008).
3.3 Training Protocol
All participants received conventional inpatient rehabilitation at TRI, including 1 hour of
physical therapy, 0.5 -1 hr of occupational therapy, and/or 0.5 – 1 hr of speech and
language therapy. These therapies were available 5 days per week and individualized to
each patient to maximize independence in mobility and daily activities. Physical therapy
included aerobic exercise which, however, was not a structured, progressive aerobic
training program.
The study intervention took place at TRI for approximately 12 weeks in addition to
conventional stroke rehabilitation therapies. Participants completed about 4 - 6 weeks of
training while they were inpatients and completed the rest of the program as outpatients.
During the inpatient period, study participants exercised at a frequency of 3 times a week
with the intensity of 60-80% of their Heart Rate Reserve (HRR). HRR was calculated
using peak heart rate obtained during the maximal exercise test. The RPE between 4 and
6 (on the 0 to 10 Borg Scale) was also used along with HR to ensure the appropriate
intensity for the participants on heart rate-altering medications (i.e. beta-blockers). The
duration of each session was progressively increased to 30 minutes based on exercise
tolerance levels. Training sessions began with a 2-minute of warm-up, and the intensity
of exercise was progressively increased to bring up the participants’ HR within their
target heart rate zone by the end of the first 10 minutes of training. At the end of the 30-
minute training, the participants continuously exercised for 2 minutes as a cool-down to
32
bring down their heart rate gradually to their resting heart rate. During the outpatient
period, the training intensity, type and time remained identical to the inpatient training
period. However, training sessions were organized to occur on the same days as
conventional outpatient therapies in order to encourage high compliance. Thus, the
training frequency for most participants was reduced to twice a week even though they
were encouraged to train 3 times a week.
The type of training included either a recumbent cross trainer (NuStep Inc., Ann Arbor,
MI) or a treadmill (Biodex™) based on walking capacity and/or personal preference.
Upon admission to the study program, if study participants were non-ambulatory, they
used the recumbent cross trainer for training. If they could complete 6 MWT upon
admission, they were asked to train on the treadmill. When treadmill training was not
possible either due to inability to walk on it or declination to use it, they were allowed to
use the recumbent cross trainer. If a participant started walking independently during the
program, then she was asked to train on the treadmill. Those who trained on the treadmill
had to wear a safety harness which did not provide any weight support.
3.4 Data Analysis
Sample size calculation was based on one of the primary outcome measures, 6MWT. A
minimum sample size required to show a clinically important difference of 54 meters in
the 6MWT (two-tailed type I error of 0.05; Power of 90%; SD of 86) was 16
(Redelmeier, Bayoumi, Goldstein, & Guyatt, 1997). Simple descriptive statistics were
used to describe subject baseline characteristics. To examine the extent of change in
dependent variables over time, one-way repeated-measures analysis of variance was used.
When significant changes in dependent variables over time were found, pair-wise
comparisons were used to detect a significant difference between any two measurement
points and the Tukey method was applied to correct for the multiplicity problems. The
level of significance was set to a P value of less than 0.05. The variables of interst were
normally distributed, therefore Pearson correlation was used to see any relationship
between the two variables.
33
Chapter 4
4.0 Results
4.1 Demographics and Training Parameters
A total of 243 stroke patients were screened at TRI for study eligibility from June 2007 to
December 2008 (see Figure 3). Of the 243 who were screened, 185 (76%) did not meet
eligibility criteria. Of the remaining 58 (24%) eligible patients, 26 declined participation,
and 32 consented and entered the study. As shown in Figure 2, major reasons for
exclusion include “unable to understand instructions” (30.3%), short length of stay at the
hospital (15.1%), CMSA leg score lower than 3 or greater than 6 (13.0%), cardiovascular
morbidity which would limit exercise tolerance (e.g. abnormal blood pressure response,
ST-segment depression, complex arrhythmias) (12.4%), and other medical reasons (e.g.
second stroke, unstable angina, neuropathic pain, etc) (10.3%). During the study, 16
participants discontinued the study intervention for various reasons (see Figure 3) and 16
completed the study. One participant was diagnosed with leukemia soon after completion
of the study. Hence, he was excluded from the study analysis to avoid his illness-related
confounding factors. Figure 3 describes participants through each stage of the study.
34
0
5
10
15
20
25
30
35
Unable
to un
derst
and i
nstru
ction
s
Short L
OS
CMSA <3 or >
6
CV Morb
idity
which w
ould
limit e
xerci
se to
leran
ce
Other M
edica
l Rea
sons
Not Retu
rning
PT advis
ed ag
ainst
Missed
Con
tactin
g Pati
ent
Other
Screen
ing fo
rms n
ot ret
urned MSK
Fatigu
e/Wea
knes
s
Reason for Exclusion
Percentage of
Excluded Patients
Figure 2. Reasons for exclusion
35
Figure 3. Flowchart depicting participants through each stage of the study Patient demographic data at baseline are presented in Table 4 for the 15 participants who
completed the study. Of the 15, six were women, and the mean age was 58.1 ± 16.3 years
old, ranging between 26 and 83. The mean leg impairment score measured by CMSA was
4.2 ± 1.2. On average, the participants were recruited into the study 34.3 ± 17.6 days after
Assessed for eligibility (N = 243)
Enrolled (n = 32)
Excluded (see Figure 2) (n = 185)
Completed baseline measures (n = 25)
Discontinued Intervention (n = 7) Reasons: recurrent stroke (1), inability to complete exercise test (1), unexpected discharge (1), personal issues (1), chronic pain in the leg (1), no outpatient therapy (1), and prolonged transition period between inpatient and outpatient period (1).
Completed hospital discharge measures (n = 18)
Completed final discharge measures (n = 16)
Discontinued Intervention (n = 7) Reasons: transportation issue (1), hip fracture due to fall (1), no outpatient therapy (2), brain cancer (1) and chest pain (1), and personal issue (1)
Discontinued Intervention (n = 2) Reasons: no outpatient therapy (1), and surgery (1).
Declined (n = 26)
Excluded from study analysis (n = 1) Reason: diagnosed with leukemia
36
stroke. No participants experienced a cardiovascular event, or injury during training, and
no one discontinued the intervention because of complaints about the study intervention.
Table 4. Participant demographics at baseline
Patient Gender Age Lesion Side Location Type CMSA leg score NIH Days post stroke SA01 M 54 R Middle cerebral artery Ischemic 4 5 37SA02 M 51 R Middle cerebral artery Unknown 3 6 55SA04 F 73 R Unknown Ischemic 4 5 19SA05 F 48 L Cerebellum Hemorrhagic 6 3 61SA07 F 72 R Paracentral gyrus Ischemic 6 0 14SA11 F 83 R Unknown Unknown 3 0 18SA12 M 42 L Cerebellum Ischemic 5 0 19SA14 M 62 R Internal capsule Ischemic 3 3 21SA16 M 54 R Temporofrontal lobe Ischemia 6 3 27SA18 M 26 L Frontal intracranial Hemorrhagic 4 5 49SA21 F 36 R Medulla Ischemic N/A* 1 42SA25 M 67 R Thalamus Hemorrhagic 3 8 20SA28 M 54 R Pontine Ischemic 3 3 24SA31 F 71 L Parietal, occipital lobe Hemorrhagic N/A** 2 40SA32 M 79 Unknown Unknown Unknown 5 2 69Mean 58.1 4.2 3.1 34.3
SD 16.3 1.2 1.2 17.6 “Days post stroke” is the days between the date of consent and date of stroke. N/A*: not available due to balance issues but deemed greater than 2 and less than 7 on CMSA by a physical therapist. N/A**: not available due to aphasia, but deemed greater than 2 and less than 7 on CASA by a physical therapist. SD: standard deviation. CMSA: Chedoke-McMaster Stroke Assessment. NIH: National Institute of Health Stroke Scale Score The mean training frequency was 2.50 ± 0.43 days/week during the inpatient period, and
it significantly reduced to 1.87 ± 0.37 days/week during the outpatient period (p =
Note: Participants who did not follow the prescribed timeline were excluded from this table. The % training intensities of SA04 and SA11 were excluded from this table since these subjects did not reach their peak heart rate during their max tests. SA05 and SA31 were excluded because their training occurred only during the outpatient period. SA28 and SA32 were excluded because their midpoint measures were taken during outpatient rehab. *Significant difference in mean frequency between inpatient and outpatient training (p = 0.0004).
37
4.2 Aerobic Capacity
When VO2peak was plotted against measurement points, there was an increase in the
mean VO2peak during the inpatient period (i.e. from baseline to midpoint) but no further
improvement during the outpatient period (from midpoint to final) (See Figure 4).
Significant increases were shown in VO2peak from baseline (mean ± SD = 15.9 ± 5.3
ml/kg/min) to midpoint (18.7 ± 4.5 ml/kg/min) (p =0.01) and also from baseline to final
(17.7 ± 4.5 ml/kg/min) (p =0.04). However, there was no significant difference in
VO2peak between midpoint and final measures (p =0.83). SA04 and SA11 were not
included in VO2peak analysis due to measurement issues.
5
10
15
20
25
Baseline Midpoint Final
VO2
(ml/k
g/m
in)
Figure 4. Baseline, midpoint and final values for VO2peak Participants (n=12) are represented by lines, and means for each time point are indicated by dots with standard deviations. Two participants (SA04 and SA11) are not shown due to measurement issues, and one participant (SA07) because of malfunctioning of equipment. Two participants (SA05 and SA31) who started the study program as outpatients are represented with longer dotted lines (-- -- --), and another two participants (SA28 and SA32) whose midpoint assessments were conducted during outpatient rehab are represented with shorter dotted lines (- - -). *Significant difference in mean VO2peak between baseline and midpoint (p = 0.01). **Significant difference in mean VO2peak between baseline and final (p = 0.04).
When change in VO2peak was plotted against number of training sessions, a positive
relationship was shown during inpatient training (r = 0.51, p = 0.24) (see Figure 5a) while
* **
38
a negative trend was observed during outpatient training (r = -0.75, p = 0.05) (see Figure
5b).
Figure 5. Relationship between change in VO2 and number of training sessions Participants (n = 7) are represented by dots. This figure only includes the participants who underwent the prescribed timeline of study measures. SA05 and SA31 were excluded because their training only occurred during the outpatient period. SA28 and SA32 were excluded because their midpoint measures were taken during outpatient rehab. Two participants (SA04 and SA11) were excluded due to measurement issues, one participant (SA07) due to malfunctioning of equipment, one participant (SA12) due to inability to perform the final max test due to pain in the hip. (a) No relationship between change in VO2peak and number of inpatient training sessions was shown. (b) No relationship between change in VO2peak and number of outpatient training sessions was shown.
4.2.1 Peak Work Rate (WRpeak)
Mean WRpeak obtained during max tests significantly increased from baseline (73.1 ±
37.3 W) to midpoint (86.2 ± 30.6 W) (p = 0.002) and also from baseline to final (90.0 ±
27.9 W) (p < 0.0001) (see Figure 6). However, there was no significant difference
between midpoint and final (p = 0.06).
-4
1
6
11
16
21
26
0 10 20 30
Number of Inpatient Training Sessions
Cha
nge
in V
O2p
eak
(ml/k
g/m
in)
0 10 20 30
Number of Outpatient Training Sessions
r = 0.51 p = 0.24 Slope = 0.4
(b) (a)
r = -0.75 p = 0.05 Slope = - 0.17
39
10
3050
70
90
110130
150
Baseline Midpoint Final
Wor
k R
ate
(Wat
t)
Figure 6. WRpeak obtained during max tests. Participants (n = 13) are represented by lines, and means for each time point are indicated by dots with standard deviations. Two participants (SA04 and SA11) were excluded due to measurement issues. Two participants (SA05 and SA31) who started the study program as outpatients are represented with longer dotted lines (-- -- --), and another two participants (SA28 and SA32) whose midpoint assessments were conducted during outpatient rehab are represented with shorter dotted lines (- - -).*Significant difference in mean WRpeak between baseline and midpoint (p = 0.002). **Significant difference in WRpeak between baseline and final (p < 0.001).
When change in WRpeak was plotted against number of inpatient training sessions, there
was a trend towards greater improvement in WR with increasing number of inpatient
sessions (r = 0.70, p = 0.05). However, this relationship was not held during outpatient
training (r = -0.62, p = 0.1) (see Figure 7).
* **
40
Figure 7. Relationship between change in WR and number of training sessions Participants (n = 8) are represented by dots. This figure only includes the participants who underwent the prescribed timeline of study measures. Two participants (SA05 and SA31) were excluded because their training only occurred during the outpatient period. SA28 and SA32 were excluded because their midpoint measures were taken during outpatient rehab. Two participants (SA04 and SA11) were excluded due to measurement issues and one participant (SA12) due to inability to perform the final max test due to pain in the hip. (a) A trend towards greater improvement in WRpeak was shown with increased number of inpatient training. (b) A trend towards greater improvement in WRpeak was not shown with increased number of outpatient training.
4.2.2 Peak Heart Rate (HRpeak)
HRpeak obtained during max tests did not change throughout the course of the study. The
mean HRpeak obtained at baseline (127.5 ± 32.5 bpm) was comparable to midpoint
(129.5 ± 32.7 bpm) and final (128.7 ± 31.6 bpm) (see Figure 8). There were no
significant differences over time (p = 0.23).
0
10
20
30
40
50
0 5 10 15 20 25
Number of Inpatient Training Sessions
Cha
nge
in W
R (W
)
0 5 10 15 20 25
Number of Outpatient Training Sessions
r = 0.70 p = 0.05 Slope = 1.8
r = -0.62 p = 0.10 Slope = -1.0
(a) (b)
41
60
80
100
120
140
160
180
200
Baseline Midpoint Final
Hea
rt R
ate
(bpm
)
Figure 8. HRpeak obtained during max tests Participants (n = 13) are represented by lines, and means for each time point are indicated by dots with standard deviations. Two participants (SA04 and SA11) were excluded due to measurement issues. Two participants (SA05 and SA31) who started the study program as outpatients are represented with longer dotted lines (-- -- --), and another two participants (SA28 and SA32) whose midpoint assessments were conducted during outpatient rehab are represented with shorter dotted lines (- - -).
4.3 Six-Minute Walk Test
With non-walkers assigned a distance of 0m (SA02, SA04, SA14, SA18, and SA25), the
mean walking distance increased from baseline (238.7 ± 208.7 m, 34.9% of predicted
6MWD (Troosters, Gosselink, & Decramer, 1999) to midpoint (316.1 ± 160.5 m, 46.4%
of predicted 6MWD) and from baseline to final (339.1 ± 138.0 m, 50.2% of predicted
value). However, from midpoint to final, the mean walking distance did not show further
improvement (see Figure 9). There were significant increases in the mean walking
distance from baseline to midpoint (p=0.006) and from baseline to final (p=0.0004).
However, there was no significant difference between midpoint and final (p=0.58).
42
0100200300400500600
Baseline Midpoint Final
Dis
tan
ce (
m)
Figure 9. Baseline, midpoint and final values for 6MWT with non-ambulatory participants (SA02, SA04, SA14, SA18, and SA25) given a score of 0m Participants (n = 15) are represented by lines, and means for each time point are indicated by dots with standard deviations. . Two participants (SA05 and SA31) who started the study program as outpatients are represented with longer dotted lines (-- -- --), and another two participants (SA28 and SA32) whose midpoint assessments were conducted during outpatient rehab are represented with shorter dotted lines (- - -). *Significant difference in mean 6MWD between baseline and midpoint (p = 0.006). **Significant difference in mean 6MWD between baseline and final (p = 0.0004).
When change in 6MWD was plotted against number of inpatient training sessions,
greater improvement was shown among the participants who had a higher number of
inpatient training sessions (see Figure 10a). There was a strong correlation between
number of training sessions and change in 6MWD during the inpatient period (r = 0.93, p
= 0.0001). However, there was no correlation between change in 6MWD and number of
outpatient training sessions (r = -0.24, p = 0.50) (see Figure 10b).
* **
43
Figure 10. Relationship between change in 6MWD and number of training sessions Participants (n = 10) are represented by dots. This figure only includes the participants who underwent the prescribed timeline of study measures. Two participants (SA05 and SA31) were excluded because their training only occurred during the outpatient period, two participants (SA28 and SA32) because their midpoint measures were taken during outpatient rehab, and one participant (SA02) because he was non-ambulatory both for baseline and midpoint. (a) A strong positive correlation between change in 6MWD and number of inpatient training sessions was shown. (b) No correlation between change in 6MWD and number of outpatient training sessions was shown.
With non-walkers at baseline removed, the mean walking distance still increased from
baseline (342.8 ± 141.9 m, 51.8% of predicted 6MWD) to midpoint (374.2 ± 132.6 m,
55.9% of predicted 6MWD) and also from baseline to final (381.8 ± 120.0 m, 57.4% of
predicted 6MWD). However, only the increase from baseline to final was significant (p =
0.03) (see Figure 11).
-50
050
100
150
200250
300
0 5 10 15 20 25
Number of Inpatient Training Sessions
Cha
nge
in 6
MW
D (m
)
0 5 10 15 20 25
Number of Outpatient Training Sessions
r = 0.93 p = 0.0001 Slope = 15.7
r = -0.24 p = 0.50 Slope = -2.1
(a) (b)
44
0
100
200
300
400
500
600
Baseline Midpoint Final
Dis
tanc
e (m
)
Figure 11. Baseline, midpoint and final 6MWT values for participants excluding non-walkers at baseline Participants (n = 10) are represented by lines, and means for each time point are indicated by dots with standard deviations. Five participants (SA02, SA04, SA14, SA18, and SA25) who were non-ambulatory at admission into the study were excluded. Two participants (SA05 and SA31) who started the study program as outpatients are represented with longer dotted lines (-- -- --), and another two participants (SA28 and SA32) whose midpoint assessments were conducted during outpatient rehab are represented with shorter dotted lines (- - -). *Significant difference in mean 6MWD between baseline and final (p = 0.03).
When change in 6MWD was plotted against number of inpatient training sessions
excluding non-walkers, greater improvement was still shown among the participants who
had more number of inpatient training sessions (see Figure 12a). There was a strong
correlation between number of training sessions and change in 6MWD during the
inpatient period (r = 0.83, p = 0.04). However, there was no correlation between change
in 6MWD and number of outpatient training sessions (r = 0.58, p = 0.22) (see Figure 12b)
*
45
Figure 12. Relationship between change in 6MWD and number of training sessions excluding non-walkers Participants (n = 6) are represented by dots. This figure only includes the participants who underwent the prescribed timeline of study measures. . In addition to five non-ambulatory participations at baseline (SA02, SA04, SA14, SA18, and SA25), two participants (SA05 and SA31) were excluded because their training only occurred during the outpatient period and two participants (SA28 and SA32) because their midpoint measures were taken during outpatient period. (a) A strong positive correlation between change in 6MWD and number of inpatient training sessions was shown. One participant (SA02), who could not ambulate independently at midpoint, was excluded. (b) No correlation between change in 6MWD and number of outpatient training sessions was shown.
4.4 Secondary Measures
Stroke Impact Scale (SIS)
The mean SIS score improved from baseline (60.8 ± 28.9 %) to midpoint (75.8 ± 19.9 %)
but plateaued from midpoint to final (76.8 ± 18.0 %) (see Figure 13). There were
significant increases from baseline to midpoint (p = 0.0009) and from baseline to final (p
= 0.0004), but no difference between midpoint and final (p = 0.96).
-30-101030507090
110130
0 5 10 15 20 25
Number of Inpatient Training Sessions
Cha
nge
in 6
MW
D (m
)
0 5 10 15 20 25
Number of Outpatient Training Sessions
r = 0.83 p = 0.04 Slope = 12.8
r = 0.62 p = 0.19 Slope = 0.30
(a) (b)
46
10.0020.0030.0040.0050.0060.0070.0080.0090.00
100.00
Baseline Midpoint Final
Sco
re (
%)
Figure 13. Scores for the SIS Participants (n = 14) are represented by lines, and means for each time point are indicated by dots with standard deviations. One participant (SA28) was excluded because he refused to complete the SIS questionnaire. Two participants (SA05 and SA31) who started the study program as outpatients are represented with longer dotted lines (-- -- --), and one participant (SA32) whose midpoint assessments were conducted during outpatient rehab is represented with shorter dotted lines (- - -). *Significant difference in mean SIS score between baseline and midpoint (p = 0.0009). **Significant difference in mean SIS score between baseline and final (p = 0.0004).
Berg Balance Scale (BBS)
The mean BBS score improved from baseline (28.9 ± 19.7) to midpoint (47.8 ± 8.8) but
plateaued from midpoint to final (50.4 ± 6.7) (see figure 14). There were significant
increases from baseline to midpoint (p < 0.0001) and from baseline to final (p < 0.0001).
However, there was no significant difference between midpoint and final (p = 0.72).
* **
47
0
10
20
30
40
50
60
Baseline Midpoint Final
Sco
re
Figure 14. Scores for the BBS Participants (n = 15) are represented by lines, and means for each time point are indicated by dots with standard deviations. Two participants (SA05 and SA31) who started the study program as outpatients are represented with longer dotted lines (-- -- --), and two participant (SA28 and SA32) whose midpoint assessments were conducted during outpatient rehab are represented with shorter dotted lines (- - -). *Significant difference in mean BSS score between baseline and midpoint (p < 0.0001). **Significant difference in mean BBS score between baseline and final (p = 0.0001).
Gait Velocity
With non-ambulatory participants assigned 0 cm/s, the mean for fast-gait velocity
significantly increased from baseline (84.3 ± 64.7 cm/s) to midpoint (118.7 ± 47.6 cm/s)
(p = 0.002), but showed no difference between midpoint and final (p = 0.71) (123.4 ±
30.1 cm/s). A significant increase was also found between baseline and final (p = 0.004)
(see Figure 15a). The mean for preferred-gait velocity increased from baseline (82.8 ±
32.4 cm/s), to midpoint (88.0 ± 38.9 cm/s), and to final (90.9 ± 24.8 cm/s) (see Figure
15b). There were also significant differences between baseline and midpoint (p = 0.0005)
and between baseline and final (p = 0.0001). However, no significance was shown
between midpoint and final (p = 0.71).
* **
48
Figure 15. Baseline, midpoint and final gait velocity values for all participants Participants (n = 13) are represented by lines, and means for each time point are indicated by dots with standard deviations. Three non-ambulatory participants (SA14, SA18, and SA25) received 0 cm/s at baseline. Two participants (SA02 and SA04) missed their assessments and excluded from analysis. Two participant (SA05 and SA31) who started the study program as outpatient is represented with a longer dotted line (-- -- --), and two participant (SA28 and SA32) whose midpoint assessments were conducted during outpatient rehab are represented with shorter dotted lines (- - -). (a) Participants were asked to walk as fast as they could at each measurement point. *Significant difference in mean gait velocity between baseline and midpoint (p = 0.002). **Significant difference in mean gait velocity between baseline and final (p = 0.004). (b) Participants were asked to walk at their preferred/comfortable walking speed at each measurement point. *Significant difference in mean gait velocity between baseline and midpoint (p = 0.0005). **Significant difference in mean gait velocity between baseline and final (p = 0.0001).
When the participants (SA02, SA04, SA14, SA18, and SA25), who could not ambulate
independently at baseline, and the participants (SA05, SA07, SA11, and SA12), who had
a missing data point, were excluded from the analysis, the mean fast-gait velocity
increased from baseline (117.4 ± 37.0 cm/s) to midpoint (143.8 ± 24.0 cm/s) (p = 0.01).
There was also a trend towards improvement from baseline to final (p = 0.06). However,
there was no significant change from midpoint to final (137.1 ± 25.0 cm/s) (p=0.65) (see
Figure 16a). The mean velocity for preferred-gait also increased from baseline (78.7 ±
33.4 cm/s) to midpoint (103.0 ± 19.9 cm/s) and then plateaued from midpoint to final
(104.2 ± 22.2 cm/s) (see Figure16b). Mean improvements from baseline to midpoint and
from baseline to final were both significant with p= 0.03 and p= 0.02, respectively. There
was no significant difference between midpoint to final (p= 0.99).
0
20
40
60
80
100
120
140
160
180
200
Baseline Midpoint Final
Vel
ocity
(cm
/s)
Baseline Midpoint Final
* * **
**
(a) (b)
49
Figure 16. Baseline, midpoint and final gait velocity values for participants with complete data Participants (n = 6) are represented by lines, and means for each time point are indicated by dots with standard deviations. Non-ambulatory participants (SA02, SA04, SA14, SA18, and SA25) at baseline and other participants (SA05, SA07, SA11, and SA12) with missing data points were excluded from the analysis. One participant (SA31) who started the study program as outpatient is represented with a longer dotted line (-- -- --), and two participant (SA28 and SA32) whose midpoint assessments were conducted during outpatient rehab are represented with shorter dotted lines (- - -). (a) Participants were asked to walk as fast as they could at each measurement point. *Significant difference in mean gait velocity between baseline and midpoint (p = 0.01). (b) Participants were asked to walk at their preferred walking speed at each measurement point. *Significant difference in mean gait velocity between baseline and midpoint (p = 0.03). **Significant difference in mean gait velocity between baseline and final (p = 0.02).
Gait Symmetry
With everyone, the mean fast-gait symmetry showed no change over time (p = 0.45):
baseline (1.24 ± 0.12), midpoint (1.31 ± 0.21), and final (1.28 ± 0.47) (see Table 6a). The
mean gait symmetry during preferred-gait also did not change from baseline (1.15 ± 0.15)
to midpoint (1.42 ± 0.23), but improved from midpoint to final (1.30 ± 0.44) with p =
0.04 (see Table 6b).
20
40
60
80
100
120
140
160
180
200
Baseline Midpoint Final
Vel
ocity
(cm
/s)
Baseline Midpoint Final
*
Baseline Midpoint FinalBaseline Midpoint Final
* **
(a) (b)
50
Table 6. Gait symmetry values obtained during fast- and preferred-gait for all participants (a) (b)
Relationship between Change in VO2peak and Change in 6MWD
No relationship between change in VO2peak and change in 6MWD was found from
baseline to midpoint (r = 0.36, p = 0.28) and also from midpoint to final (r = -0.31, p =
0.35) (see Figure 17).
(a) (b)
-100
-50
0
50
100
150
200
250
300
-5 0 5 10 15
Change in VO2peak (ml/kg/min)
Ch
an
ge
in 6
MW
D (
m)
-100
-50
0
50
100
150
200
250
300
-5 0 5 10 15
Change in VO2peak (ml/kg/min)
Ch
ang
e in
6M
WD
(m)
Figure 17. Relationship between change in 6MWD and change in VO2peak. Participants (n = 11) with no missing data (SA01, SA02, SA05, SA14, SA16, SA18, SA21, SA25, SA28, SA31, and 32) are included in this analysis. (a) No relationship was found between change in 6MWD and change in VO2peak from baseline to midpoint. (b) No relationship was found between change in 6MWD and change in VO2peak from midpoint to final.
r = 0.36 p = 0.28 Slope = 9.9
r = -0.31 p = 0.35 Slope = -9.3
52
Comparison to Tang et al
The current study showed the greater degree of improvements in VO2peak and WRpeak
compared to the previous study from our group (Tang, Sibley, Thomas, Bayley,
Richardson, McIlroy, & Brooks, 2009) (see Table 8 and Figure 18). In the current study,
VO2peak increased by 4.2 ± 3.7 ml/kg/min (30%) and WRpeak by 16.4 ± 14.3 W (20%)
during inpatient training as opposed to VO2peak by 1.4 ± 2.3 ml/kg/min (13%) and
WRpeak by 10.8 ± 17.3 W (13%) in the Exercise group of the previous study (Tang,
Sibley, Thomas, Bayley, Richardson, McIlroy, & Brooks, 2009). However, the previous
study reported greater improvements in 6MWD and SIS than the current study.
Table 8. Main outcome comparison between current and previous studies
Note: For the comparison purpose, only the subjects (SA01, SA02, SA04, SA07, SA11, SA12, SA14, SA16, SA18, SA21, and SA25) who followed the prescribed timeline are included for the current study. SA04, SA07, SA11, and SA12 were excluded from the VO2peak and WRpeak analysis due to measurement issues but included for the 6MWD and SIS analysis.
53
Figure 18. Comparison between current and previous study For the comparison purpose, only the subjects (SA01, SA02, SA04, SA07, SA11, SA12, SA14, SA16, SA18, SA21, and SA25) who followed the prescribed timeline are included for the current study. SA04, SA07, SA11, and SA12 were excluded from the VO2peak analysis due to measurement issues but included for the 6MWD analysis. “Admission” and “Discharge” represent measurement points at admission into study and at discharge from inpatient rehabilitation, respectively. (a) The current study showed a 30% increase in mean VO2peak while Exercise group from the previous study by Tang et al showed a 13% increase in mean VO2peak following aerobic training. (b) The current study showed a 55% increase in mean 6MWD while Exercise group from the previous study by Tang et al showed a 61% increase in mean 6MWD following aerobic training.
The current participants also had higher baseline values for VO2peak, WRpeak and
6WMD and were also less impaired based on the NIH score compared to the participants
of the previous study (see Table 9) (Tang, Sibley, Thomas, Bayley, Richardson, McIlroy,
& Brooks, 2009).
Table 9. Patient characteristics from current and previous studies at baseline
Note: For the current study, the participants who followed the prescribed timeline and the participants (SA05, SA28, SA31, and SA32) who did not follow the prescribed timeline were used. SA04 and SA11 was excluded from the VO2peak analysis but included in the 6MWD analysis. CMSA: Chedoke-McMaster Stroke Assessment NIH: National Institute of Health Stroke Scale
10
12
14
16
18
20
Admission Discharge
VO
2 (m
l/kg/
min
)
150
200
250
300
350
Admission Discharge
Dis
tanc
e (m
)
Tang et alCurrent Study
(a) (b)
54
Chapter 5
5.0 Discussion
Results from the study contribute to a growing but small body of evidence that early
aerobic exercise following stroke is beneficial to cardiovascular fitness and walking
capacity in individuals in the subacute phase after stroke. Significant gains were observed
in VO2peak, 6MWD, peak work rate, health-related quality of life, balance, and gait
velocity. A novel aspect of this study was that it did not only examine the effect of early
aerobic training after stroke but also compared the extent of improvements achieved
during the inpatient and outpatient periods. Main findings showed that individuals in the
subacute phase after stroke have a markedly reduced aerobic and walking capacity and
early aerobic training was effective in improving these study outcomes. It is important to
note that most of the improvements occurred during the inpatient period while relatively
small or no improvement was shown during the outpatient period. Preliminary evidence
demonstrated greater improvements with increasing number of inpatient training sessions
while this relationship was not held during the outpatient period.
Reduced cardiovascular fitness and low walking capacity found in the current study are
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Pang, M. Y. C., & Eng, J. J. (2008). Determinants of improvement in walking capacity
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Chapter 8 8.1 Chedoke-McMaster Assessment Scale
STAGE R/L ARM R/L HAND R/L LEG R/L FOOT
1 Not yet Stage 2 Not yet Stage 2 Not yet Stage
2 Not yet Stage 2
2
SIT resistance to
passive shoulder abduction or
elbow extension
SIT positive Hoffman
CROOK LYING
resistance to passive hip or knee flexion
CROOK LYING
resistance to passive
dorsiflexion
facilitated elbow extension
resistance to passive wrist
or finger extension
facilitated flexion
facilitated dorsiflexion or toe extension
facilitated elbow flexion facilitated
finger flexion facilitated extension facilitated
plantarflexion
3
touch opposite knee
wrist extension >
½ range
abduction: adduction to
neutral SUPINE plantar flexion >
½ range
touch chin finger/wrist flexion > ½
range hip flexion to
90° SIT some dorsiflexion
shoulder
shrugging > ½ range
supination, thumb
extension: thumb to
index finger
full extension extension of toes
4
extension
synergy then flexion synergy
finger
extension, then flexion
hip flexion to 90° then extension synergy
some eversion
shoulder flexion to 90°
thumb extension >
½ range, then lateral prehension
bridging with
equal weightbearing
inversion
elbow at side, 90° flexion:
supination, then pronation
finger flexion with lateral prehension
SIT knee flexion beyond 100°
legs crossed: dorsiflexion,
then plantarflexion
5
flexion synergy, then
extension synergy
finger flexion
then extension
CROOK LYING
extension synergy, then
flexion synergy
legs crossed: toe extension
with ankle plantarflexion
shoulder
abduction to 90° with pronation
pronation:
finger abduction
SIT raise thigh off bed
sitting with knee extended: ankle plantarflexion,
then dorsiflexion
shoulder abduction to
90°: pronation then supination
opposition of little finger to
thumb STAND
hip extension with knee
flexion STAND heel on floor:
eversion
6
hand from knee to forehead 5x/5
sec
pronation: tap index
finger 10x/5 sec
SIT lift foot off
floor 5x/5 sec
heel on floor: tap
foot 5x/5 sec
shoulder flexion to 90°: trace a
figure 8
pistol grip: pull trigger then return
full range internal rotation
foot circumduction
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raise arm
overhead with full supination
wrist and finger
extension with finger abduction
STAND trace a pattern:
forward, side, back, return
knee straight, heel off floor:
eversion
7
clap hands overhead, then
clap hands behind back
3x/5 sec
thumb to finger tips,
then reverse 3x/12 secs
unsupported: rapid high stepping 10x/5 sec
heel touch forward, then reverse to toe
touching behind 5x/10 sec
shoulder flexion to 90° flexion: scissor in front
3x/5 sec
bounce a ball 4x in
succession, then catch
trace a pattern quickly:
forward, side, back, reverse
circumduction quickly, reverse
elbow at side, 90° flexion:
resisted shoulder
external rotation
pour 250 ml from 1 litre
pitcher, then reverse
on weak leg with support: hop on weak
leg
up on toes, then back on heels 5
times
STAGE OF
ARM STAGE OF HAND STAGE OF
LEG STAGE OF FOOT
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8.2 VO2peak Assessment Form
Time HR RPE (0-
10) B L
BP RPM Work Rate (watts)
Comments/ Appearance
Rest Seat distance: _______
Warm-up 0:00 – 2:00 50 10W
2:01 – 3:00 50 15W
3:01 – 4:00 50 20W
4:01 – 5:00 50 25W
5:01 – 6:00 50 30W
6:01 – 7:00 50 35W
7:01 – 8:00 50 40W
8:01 – 9:00 50 45W
9:01 – 10:00 50 50W 10:01 – 11:00 50 55W
11:01 – 12:00 50 60W
12:01 – 13:00 50 65W
13:01 – 14:00 50 70W
End of test 50 10W Time: _________
Cool-down 1 min post
Cool-down 2 min post
10 min post
TOTAL TIME of Test _______________
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8.3 Modified Borg Rating of Perceived Exertion Scale
Borg RPE Scale
0 Nothing at all 0.5 Very, very light (just noticeable) 1 Very light 2 Light (Weak) 3 Moderate 4 5 Heavy (Strong) 6 7 Very heavy 8 9 10 Very, very heavy (maximal)
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8.4 Stroke Impact Scale
Stroke Impact Scale VERSION 3.0
The purpose of this questionnaire is to evaluate how stroke has impacted your health and life. We want to know from YOUR POINT OF VIEW how stroke has affected you. We will ask you questions about impairments and disabilities caused by your stroke, as well as how stroke has affected your quality of life. Finally, we will ask you to rate how much you think you have recovered from your stroke.
78
Stroke Impact Scale These questions are about the physical problems which may have occurred as a result of your stroke. 1. In the past week, how would you rate the strength of your....
A lot of strength
Quite a bit of
strength
Some strength
A little strength
No strength
at all a. Arm that was most affected by your stroke?
5 4 3 2 1
b. Grip of your hand that was most affected by your stroke?
5 4 3 2 1
c. Leg that was most affected by your stroke?
5 4 3 2 1
d. Foot/ankle that was most affected by your stroke?
5 4 3 2 1
These questions are about your memory and thinking.
2. In the past week, how difficult was it for you to...
Not difficult
at all
A little difficult
Some-what
difficult
Very difficult
Extremely difficult
a. Remember things that people just told you?
5 4 3 2 1
b. Remember things that happened the day before?
5 4 3 2 1
c. Remember to do things (e.g. keep scheduled appointments or take medication)?
5 4 3 2 1
d. Remember the day of the week? 5 4 3 2 1
e. Concentrate? 5 4 3 2 1
f. Think quickly? 5 4 3 2 1
g. Solve everyday problems? 5 4 3 2 1
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These questions are about how you feel, about changes in your mood and about your ability to control your emotions since your stroke.
3. In the past week, how often did you...
None of the time
A little of the time
Some of the time
Most of the time
All of the time
a. Feel sad? 5 4 3 2 1
b. Feel that there is nobody you are close to?
5 4 3 2 1
c. Feel that you are a burden to others?
5 4 3 2 1
d. Feel that you have nothing to look forward to?
5 4 3 2 1
e. Blame yourself for mistakes that you made?
5 4 3 2 1
f. Enjoy things as much as ever? 5 4 3 2 1
g. Feel quite nervous? 5 4 3 2 1
h. Feel that life is worth living? 5 4 3 2 1
i. Smile and laugh at least once a day?
5 4 3 2 1
The following questions are about your ability to communicate with
other people, as well as your ability to understand what you read and what you hear in a conversation.
4. In the past week, how difficult was it to...
Not difficult
at all
A little difficult
Some-what
difficult
Very difficult
Extremely difficult
a. Say the name of someone who was in front of you?
5 4 3 2 1
b. Understand what was being said to you in a conversation?
5 4 3 2 1
c. Reply to questions? 5 4 3 2 1
d. Correctly name objects? 5 4 3 2 1
e. Participate in a conversation with a group of people?
5 4 3 2 1
f. Have a conversation on the telephone?
5 4 3 2 1
g. Call another person on the telephone, including selecting the correct phone number and dialing?
5 4 3 2 1
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The following questions ask about activities you might do during a typical day.
5. In the past 2 weeks, how difficult was it to...
Not difficult
at all
A little difficult
Some-what
difficult
Very difficult
Could not do at all
a. Cut your food with a knife and fork?
5 4 3 2 1
b. Dress the top part of your body? 5 4 3 2 1
c. Bathe yourself? 5 4 3 2 1
d. Clip your toenails? 5 4 3 2 1
e. Get to the toilet on time? 5 4 3 2 1
f. Control your bladder (not have an accident)?
5 4 3 2 1
g. Control your bowels (not have an accident)?
5 4 3 2 1
h. Do light household tasks/chores (e.g. dust, make a bed, take out garbage, do the dishes)?
5 4 3 2 1
i. Go shopping? 5 4 3 2 1
j. Do heavy household chores (e.g. vacuum, laundry or yard work)?
5 4 3 2 1
The following questions are about your ability to be mobile,
at home and in the community. 6. In the past 2 weeks, how difficult was it to...
Not difficult
at all
A little difficult
Some-what
difficult
Very difficult
Could not do at all
a. Stay sitting without losing your balance?
5 4 3 2 1
b. Stay standing without losing your balance?
5 4 3 2 1
c. Walk without losing your balance?
5 4 3 2 1
d. Move from a bed to a chair? 5 4 3 2 1
e. Walk one block? 5 4 3 2 1
f. Walk fast? 5 4 3 2 1
g. Climb one flight of stairs? 5 4 3 2 1
h. Climb several flights of stairs? 5 4 3 2 1
i. Get in and out of a car? 5 4 3 2 1
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The following questions are about your ability to use your hand that was MOST AFFECTED by your stroke.
7. In the past 2 weeks, how difficult was it to use your hand that was most affected by your stroke to...
Not difficult
at all
A little difficult
Somewhat difficult
Very difficult
Could not do at all
a. Carry heavy objects (e.g. bag of groceries)?
5 4 3 2 1
b. Turn a doorknob? 5 4 3 2 1
c. Open a can or jar? 5 4 3 2 1
d. Tie a shoe lace? 5 4 3 2 1
e. Pick up a dime? 5 4 3 2 1
The following questions are about how stroke has affected your ability to participate in the activities that you usually do, things that are
meaningful to you and help you to find purpose in life. 8. During the past 4 weeks, how much of the time have you been limited in...
None of the time
A little of the time
Some of the time
Most of the time
All of the time
a. Your work (paid, voluntary or other)
5 4 3 2 1
b. Your social activities? 5 4 3 2 1
c. Quiet recreation (crafts, reading)? 5 4 3 2 1
d. Active recreation (sports, outings, travel)?
5 4 3 2 1
e. Your role as a family member and/or friend?
5 4 3 2 1
f. Your participation in spiritual or religious activities?
5 4 3 2 1
g. Your ability to control your life as you wish?
5 4 3 2 1
h. Your ability to help others? 5 4 3 2 1
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9. Stroke Recovery
On a scale of 0 to 100, with 100 representing full recovery and 0 representing no recovery, how much have you
8.5 Berg Balance Scale Assessor: _______________________________ TOTAL
1 – SITTING TO STANDING 8 – REACHING FORWARD WITH OUTSTRETCHED ARM 4 = able to stand without using hands, stabilize independently 4 = can reach forward confidently > 25 cm (10 in) 3 = able to independently using hands 3 = c can reach forward > 12 cm safely (5 in) 2 = able to stand using hands after several tries 2 = can reach forward > 5 cm safely (2 in) 1 = needs minimal aid to stand or to stabilize 1 = reached forward but needs supervision 0 = needs moderate or maximal assist to stand 0 = loses balance while trying / requires external support 2 – STANDING UNSUPPORTED 9 – PICK UP OBJECT FROM FLOOR (STANDING) 4 = able to stand safely 2 min 4 = able to pick up slipper safely and easily 3 = able to stand 2 min with supervision 3 = able to pick up slipper but needs supervision 2 = able to stand 30 s unsupported 2 = unable but reaches 2-5 cm from slipper, balances 1 = needs several tries to stand 30 s unsupported 1 = unable and needs supervision while trying 0 = unable to stand 30 s unassisted 0 = needs assistance to keep from falling / unable to try
If able to stand 2 minutes unsupported, proceed to #4
3 – SITTING UNSUPPORED FEET ON FLOOR 10 – TURNING TO LOOK BEHIND OVER BOTH SHOULDERS
4 = able to sit safely and securely 2 min 4 = looks behind both sides, weight shifts (WS) well 3 = able to sit 2 min with supervision 3 = looks behind one side, other side shows less WS 2 = able to sit 30 s 2 = turns sideways only but maintains balance 1 = able to sit 10 s 1 = needs supervision when turning 0 = unable to sit without support 10 s 0 = needs assist to keep from losing balance or falling 4 – STANDING TO SITTING 11 – TURNS 360 DEGREES 4 = sits safely with minimal use of hands 4 = able to turn 3600 safely in ≤ 4 s 3 = controls descent by using hands 3 = able to turn 3600 one side only in ≤ 4 s 2 = uses back of legs against chair to control descent 2 = able to turn 3600 safely but slowly 1 = sits independently with uncontrolled descent 1 = needs close supervision or verbal cuing 0 = needs assistance to sit 0 = needs assistance to keep from falling / unable to try 5 – TRANSFERS 12 – PLACING ALTERNATE FOOT ON STEP (STANDING) 4 = able to transfer safely with minor use of hands 4 = able to stand independently and safely 8 steps / 20 s 3 = able to transfer safely with definite use of hands 3 = able to stand independently 8 steps in > 20 s 2 = able to transfer safely with verbal cues / supervision 2 = able to complete 4 steps without aid with supervision 1 = needs 1 person assist 1 = able to complete > 2 steps needs minimal assist 0 = needs 2 people to assist or supervise to be safe 0 = needs assistance to keep from falling / unable to try 1 – SITTING TO STANDING 8 – REACHING FORWARD WITH OUTSTRETCHED ARM 6 – STANDING UNSUPPORTED EYES CLOSED 13 – STANDING UNSUPPORTED, ONE FOOT IN FRONT 4 = able to stand 10 s safely 4 = places foot in tandem independently, hold 30 s 3 = able to stand 10 s with supervision 3 = places foot ahead of other independently, hold 30 s 2 = able to stand 3 s 2 = takes small step independently, hold 30 s 1 = unable to keep eyes closed 3 s but stays steady 1 = needs help to step but can hold 15 s 0 = needs help to keep from falling 0 = loses balance while stepping or standing 7 – STANDING UNSUPPORTED WITH FEET TOGETHER 14 – STANDING ON ONE LEG 4 = places feet together independently, stands 1 min safely 4 = able to lift leg independently, hold > 10 s 3 = places feet together independently, stands 1 min superv 3 = able to lift leg independently, hold 5-10 s 2 = places feet together independently, unable to hold 30 s 2 = able to lift leg independently, hold ≥ 3 s 1 = needs help to attain position, able to stand 15 s 1 = tries to lift leg, hold < 3 s, remains standing 0 = needs help to attain position, unable to hold 15 s 0 = unable to try or needs assist to prevent fall