Cost-effectiveness of Forced Aerobic Exercise for Stroke Rehabilitation

Study Overview
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Brief Summary
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The purpose of this study is to investigate whether aerobic exercise improves the participant's ability to recover function in the arm and leg affected by the participant's stroke. The investigators are also calculating the cost effectiveness of the rehabilitation interventions.

Detailed Description
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The aims of the study are to determine the clinical efficacy and cost-effectiveness of combining aerobic exercise training with upper extremity motor task practice to improve motor recovery following stroke. It is hypothesized that the neurophysiologic impact of aerobic exercise may augment motor recovery associated with motor task practice. To test this hypothesize, 60 individuals with chronic stroke will be recruited to participate in this randomized clinical trial. Following screening and informed consent, all participants will undergo an exercise stress test to determine response to maximal exertion. Following the stress test, baseline clinical assessments will be obtained to quantify upper extremity function, gait, endurance, and self-reported quality of life. Additionally, variables to determine degree of disability will be obtained. Individuals will be randomized to one of two interventions: 45 min of forced-rate aerobic exercise paired with 45 min of upper limb repetitive task practice or two back-to-back 45-minute sessions of upper limb repetitive task practice. The interventions will occur 3 times per week for 8 weeks. Outcomes assessing motor function and disability will be repeated at mid-treatment, end of treatment, and at 4 weeks, 6-months and 12-months following end of treatment.

Official Title
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Cost-effectiveness and Efficacy of a Combined Intervention to Facilitate Motor Recovery Following Stroke

Conditions
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Stroke, Cerebrovascular Disorders, Brain Diseases, Central Nervous System Diseases, Nervous System Diseases, Vascular Diseases, Cardiovascular Diseases

Intervention / Treatment
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* Behavioral: Aerobic Exercise
* Behavioral: Upper Extremity Repetitive Task Practice


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ≥ 6 months following single ischemic or hemorrhagic stroke confirmed with neuroimaging, Fugl-Meyer motor score 19-55 in the involved upper extremity, Ambulatory ≥ 20 meters with no more than contact guard assistance, and 18-85 years of age. Exclusion Criteria: hospitalization for myocardial infarction, heart failure or heart surgery within 3 months, cardiac arrhythmia, hypertrophic cardiomyopathy, severe aortic stenosis, pulmonary embolus, significant contractures, anti-spasticity injection within 3 months of enrollment and other contraindication to exercise

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Aerobic Exercise & Repetitive Task Practice<br>Participants will perform the following: 45 minutes of cycling 45 minutes of upper extremity repetitive arm exercises | Behavioral: Aerobic Exercise<br>* Cycling on a recumbent stationary bike with a specialized motor that forces the individual to cycle approximately 30-35% faster than your self-selected speed<br>Behavioral: Upper Extremity Repetitive Task Practice<br>* Repetitive arm exercises<br>|
| Active Comparator: Upper Extremity Repetitive Task Practice Only<br>Participants will perform the following: 1. 90 minutes of upper extremity repetitive arm exercises | Behavioral: Upper Extremity Repetitive Task Practice<br>* Repetitive arm exercises<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fugl-Meyer Assessment (FMA) | This is a 33 item assessment of post-stroke upper extremity impairment. Total score is reported, scores range from 0-66, with higher scores indicating a better outcome. | Baseline | 
| Fugl-Meyer Assessment (FMA) | This is a 33 item assessment of post-stroke upper extremity impairment. Total score is reported, scores range from 0-66, with higher scores indicating a better outcome. | midpoint (4 weeks from Baseline) | 
| Fugl-Meyer Assessment (FMA) | This is a 33 item assessment of post-stroke upper extremity impairment. Total score is reported, scores range from 0-66, with higher scores indicating a better outcome. | end of treatment (8 weeks from Baseline) | 
| Fugl-Meyer Assessment (FMA) | This is a 33 item assessment of post-stroke upper extremity impairment. Total score is reported, scores range from 0-66, with higher scores indicating a better outcome. | end of treatment +4 weeks (12 weeks from Baseline) | 
| Fugl-Meyer Assessment (FMA) | This is a 33 item assessment of post-stroke upper extremity impairment. Total score is reported, scores range from 0-66, with higher scores indicating a better outcome. | end of treatment +6 months (8 months from Baseline) | 
| Fugl-Meyer Assessment (FMA) | This is a 33 item assessment of post-stroke upper extremity impairment. Total score is reported, scores range from 0-66, with higher scores indicating a better outcome. | end of treatment +1 year (14 months from Baseline) | 
| Action Research Arm Test (ARAT) | This is an assessment of post-stroke upper extremity function. Total score is reported, scores range from 0-57, with higher scores indicating a better outcome. | Baseline | 
| Action Research Arm Test (ARAT) | This is an assessment of post-stroke upper extremity function. Total score is reported, scores range from 0-57, with higher scores indicating a better outcome. | end of treatment (8 weeks from Baseline) | 
| Action Research Arm Test (ARAT) | This is an assessment of post-stroke upper extremity function. Total score is reported, scores range from 0-57, with higher scores indicating a better outcome. | end of treatment +4 weeks (12 weeks from Baseline) | 
| Action Research Arm Test (ARAT) | This is an assessment of post-stroke upper extremity function. Total score is reported, scores range from 0-57, with higher scores indicating a better outcome. | end of treatment +6 months (8 months from Baseline) | 
| Action Research Arm Test (ARAT) | This is an assessment of post-stroke upper extremity function. Total score is reported, scores range from 0-57, with higher scores indicating a better outcome. | end of treatment +1 year (14 months from Baseline) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Wolf Motor Function Test (WMFT) | This consists of 2 strength tasks and 15 timed tasks of both the affected upper extremity and the unaffected upper extremity. Total Functional Ability Score is reported, scores range from 0-75, with higher scores indicating a better outcome. | Baseline | 
| Wolf Motor Function Test (WMFT) | This consists of 2 strength tasks and 15 timed tasks of both the affected upper extremity and the unaffected upper extremity. Total Functional Ability Score is reported, scores range from 0-75, with higher scores indicating a better outcome. | end of treatment (8 weeks from Baseline) | 
| Stroke Impact Scale (SIS) | This is a self-reported questionnaire evaluating quality of life. Normalized Hand Function is reported, scores range from 0-100, with higher scores indicating a better outcome. | Baseline | 
| Stroke Impact Scale (SIS) | This is a self-reported questionnaire evaluating quality of life. Normalized Hand Function is reported, scores range from 0-100, with higher scores indicating a better outcome. | end of treatment (8 weeks from Baseline) | 
| Stroke Impact Scale (SIS) | This is a self-reported questionnaire evaluating quality of life. Normalized Hand Function is reported, scores range from 0-100, with higher scores indicating a better outcome. | end of treatment +6 months (8 months from Baseline) | 
| Stroke Impact Scale (SIS) | This is a self-reported questionnaire evaluating quality of life. Normalized Hand Function is reported, scores range from 0-100, with higher scores indicating a better outcome. | end of treatment +1 year (14 months from Baseline) | 
| Patient-Reported Outcomes Measurement Information System (PROMIS-29) | A self-reported questionnaire evaluating physical, mental, and social health. T-scores are reported separately for Anxiety, Depression, Fatigue, Sleep Disturbance, Ability to Participate in Social Roles and Activities, Physical Function, and Pain Interference. A score of 40 is one standard deviation lower than the mean of the reference population. A score of 60 is one standard deviation higher than the mean of the reference population. For PROMIS measures, higher scores equals more of the concept being measured (e.g., more Fatigue, more Physical Function). Thus a score of 60 is one standard deviation above the average referenced population. This could be a desirable or undesirable outcome, depending upon the concept being measured. | Baseline | 
| Patient-Reported Outcomes Measurement Information System (PROMIS-29) | A self-reported questionnaire evaluating physical, mental, and social health. T-scores are reported separately for Anxiety, Depression, Fatigue, Sleep Disturbance, Ability to Participate in Social Roles and Activities, Physical Function, and Pain Interference. A score of 40 is one standard deviation lower than the mean of the reference population. A score of 60 is one standard deviation higher than the mean of the reference population. For PROMIS measures, higher scores equals more of the concept being measured (e.g., more Fatigue, more Physical Function). Thus a score of 60 is one standard deviation above the average referenced population. This could be a desirable or undesirable outcome, depending upon the concept being measured. | end of treatment (8 weeks from Baseline) | 
| Patient-Reported Outcomes Measurement Information System (PROMIS-29) | A self-reported questionnaire evaluating physical, mental, and social health. T-scores are reported separately for Anxiety, Depression, Fatigue, Sleep Disturbance, Ability to Participate in Social Roles and Activities, Physical Function, and Pain Interference. A score of 40 is one standard deviation lower than the mean of the reference population. A score of 60 is one standard deviation higher than the mean of the reference population. For PROMIS measures, higher scores equals more of the concept being measured (e.g., more Fatigue, more Physical Function). Thus a score of 60 is one standard deviation above the average referenced population. This could be a desirable or undesirable outcome, depending upon the concept being measured. | end of treatment +6 months (8 months from Baseline) | 
| Patient-Reported Outcomes Measurement Information System (PROMIS-29) | A self-reported questionnaire evaluating physical, mental, and social health. T-scores are reported separately for Anxiety, Depression, Fatigue, Sleep Disturbance, Ability to Participate in Social Roles and Activities, Physical Function, and Pain Interference. A score of 40 is one standard deviation lower than the mean of the reference population. A score of 60 is one standard deviation higher than the mean of the reference population. For PROMIS measures, higher scores equals more of the concept being measured (e.g., more Fatigue, more Physical Function). Thus a score of 60 is one standard deviation above the average referenced population. This could be a desirable or undesirable outcome, depending upon the concept being measured. | end of treatment +1 year (14 months from Baseline) | 
| Center for Epidemiological Studies-Depression (CES-D) | This is a 20 item assessment of depressive symptomology. Total score is reported, scores range from 0-60, with higher scores indicating higher risk of depression. | Baseline | 
| Center for Epidemiological Studies-Depression (CES-D) | This is a 20 item assessment of depressive symptomology. Total score is reported, scores range from 0-60, with higher scores indicating higher risk of depression. | end of treatment (8 weeks from Baseline) | 
| Center for Epidemiological Studies-Depression (CES-D) | This is a 20 item assessment of depressive symptomology. Total score is reported, scores range from 0-60, with higher scores indicating higher risk of depression. | end of treatment +6 months (8 months from Baseline) | 
| Center for Epidemiological Studies-Depression (CES-D) | This is a 20 item assessment of depressive symptomology. Total score is reported, scores range from 0-60, with higher scores indicating higher risk of depression. | end of treatment +1 year (14 months from Baseline) | 
| Six-Minute Walk Test (6MWT) | Total distance (feet) traveled over a 6 minute period. | Baseline | 
| Six-Minute Walk Test (6MWT) | Total distance (feet) traveled over a 6 minute period. | end of treatment (8 weeks) | 
| Six-Minute Walk Test (6MWT) | Total distance (feet) traveled over a 6 minute period. | end of treatment +4 weeks (12 weeks from Baseline) | 
| Six-Minute Walk Test (6MWT) | Total distance (feet) traveled over a 6 minute period. | end of treatment +6 months (8 months from Baseline) | 
| Six-Minute Walk Test (6MWT) | Total distance (feet) traveled over a 6 minute period. | end of treatment +1 year (14 months from Baseline) | 
| Modified Rankin Scale | 0-6 scale to determine degree of disability in individuals with a disabling condition. A score of 0 indicates no symptoms, 1 indicates no significant disability despite symptoms, 2 indicates slight disability, 3 indicates moderate disability, 4 indicates moderately severe level of disability, 5 indicates severe disability, and 6 indicates death. | Baseline | 
| Modified Rankin Scale | 0-6 scale to determine degree of disability in individuals with a disabling condition. A score of 0 indicates no symptoms, 1 indicates no significant disability despite symptoms, 2 indicates slight disability, 3 indicates moderate disability, 4 indicates moderately severe level of disability, 5 indicates severe disability, and 6 indicates death. | end of treatment (8 weeks from Baseline) | 
| Modified Rankin Scale | 0-6 scale to determine degree of disability in individuals with a disabling condition. A score of 0 indicates no symptoms, 1 indicates no significant disability despite symptoms, 2 indicates slight disability, 3 indicates moderate disability, 4 indicates moderately severe level of disability, 5 indicates severe disability, and 6 indicates death. | end of treatment +6 months (8 months from Baseline) | 
| Modified Rankin Scale | 0-6 scale to determine degree of disability in individuals with a disabling condition. A score of 0 indicates no symptoms, 1 indicates no significant disability despite symptoms, 2 indicates slight disability, 3 indicates moderate disability, 4 indicates moderately severe level of disability, 5 indicates severe disability, and 6 indicates death. | end of treatment +1 year (14 months from Baseline) | 
| Right Step Length | Mean right step length (cm) across two 2-minute walking trials | Baseline | 
| Right Step Length | Mean right step length (cm) across two 2-minute walking trials | end of treatment (8 weeks from Baseline) | 
| Left Step Length | Mean left step length (cm) across two 2-minute walking trials | Baseline | 
| Left Step Length | Mean left step length (cm) across two 2-minute walking trials | end of treatment (8 weeks from Baseline) | 
| Right Step Width | Mean right step width (cm) across two 2-minute walking trials | Baseline | 
| Right Step Width | Mean right step width (cm) across two 2-minute walking trials | end of treatment (8 weeks from Baseline) | 
| Left Step Width | Mean left step width (cm) across two 2-minute walking trials | Baseline | 
| Left Step Width | Mean left step width (cm) across two 2-minute walking trials | end of treatment (8 weeks from Baseline) | 
| Right Stance Time | Mean time (in seconds) spent in stance phase on the right lower extremity across two 2-minute walking trials | Baseline | 
| Right Stance Time | Mean time (in seconds) spent in stance phase on the right lower extremity across two 2-minute walking trials | end of treatment (8 weeks from Baseline) | 
| Left Stance Time | Mean time (in seconds) spent in stance phase on the left lower extremity across two 2-minute walking trials | Baseline | 
| Left Stance Time | Mean time (in seconds) spent in stance phase on the left lower extremity across two 2-minute walking trials | end of treatment (8 weeks from Baseline) | 
| Right Swing Time | Mean time (in seconds) spent in swing phase on the right lower extremity across two 2-minute walking trials | Baseline | 
| Right Swing Time | Mean time (in seconds) spent in swing phase on the right lower extremity across two 2-minute walking trials | end of treatment (8 weeks from Baseline) | 
| Left Swing Time | Mean time (in seconds) spent in swing phase on the left lower extremity across two 2-minute walking trials | Baseline | 
| Left Swing Time | Mean time (in seconds) spent in swing phase on the left lower extremity across two 2-minute walking trials | end of treatment (8 weeks from Baseline) | 
| Walking Speed | Mean m/s across two 2-minute walking trials | Baseline | 
| Walking Speed | Mean m/s across two 2-minute walking trials | end of treatment (8 weeks from Baseline) | 
| Walking Cadence | Mean steps/minute across two 2-minute walking trials | Baseline | 
| Walking Cadence | Mean steps/minute across two 2-minute walking trials | end of treatment (8 weeks from Baseline) | 
| Left Knee Range of Motion | Mean peak degree of left knee flexion across two 2-minute walking trials | Baseline | 
| Left Knee Range of Motion | Mean peak degree of left knee flexion across two 2-minute walking trials | end of treatment (8 weeks from Baseline) | 
| Right Knee Range of Motion | Mean peak degree of right knee flexion across two 2-minute walking trials | Baseline | 
| Right Knee Range of Motion | Mean peak degree of right knee flexion across two 2-minute walking trials | end of treatment (8 weeks from Baseline) | 
| Left Ankle Range of Motion | Mean peak degree of left ankle dorsiflexion across two 2-minute walking trials | Baseline | 
| Left Ankle Range of Motion | Mean peak degree of left ankle dorsiflexion across two 2-minute walking trials | end of treatment (8 weeks from Baseline) | 
| Right Ankle Range of Motion | Mean peak degree of right ankle dorsiflexion across two 2-minute walking trials | Baseline | 
| Right Ankle Range of Motion | Mean peak degree of right ankle dorsiflexion across two 2-minute walking trials | end of treatment (8 weeks from Baseline) | 
| Left Hip Range of Motion (sagittal plane) | Mean peak degree of left hip flexion across two 2-minute walking trials | Baseline | 
| Left Hip Range of Motion (sagittal plane) | Mean peak degree of left hip flexion across two 2-minute walking trials | end of treatment (8 weeks from Baseline) | 
| Right Hip Range of Motion (sagittal plane) | Mean peak degree of right hip flexion across two 2-minute walking trials | Baseline | 
| Right Hip Range of Motion (sagittal plane) | Mean peak degree of right hip flexion across two 2-minute walking trials | end of treatment (8 weeks from Baseline) | 
| Left Hip Range of Motion (coronal plane) | Mean peak degree of left hip abduction across two 2-minute walking trials | Baseline | 
| Left Hip Range of Motion (coronal plane) | Mean peak degree of left hip abduction across two 2-minute walking trials | end of treatment (8 weeks from Baseline) | 
| Right Hip Range of Motion (coronal plane) | Mean peak degree of right hip abduction across two 2-minute walking trials | Baseline | 
| Right Hip Range of Motion (coronal plane) | Mean peak degree of right hip abduction across two 2-minute walking trials | end of treatment (8 weeks from Baseline) | 
| Left Hip Range of Motion (transverse plane) | Mean peak degree of left hip external rotation across two 2-minute walking trials | Baseline | 
| Left Hip Range of Motion (transverse plane) | Mean peak degree of left hip external rotation across two 2-minute walking trials | end of treatment (8 weeks from Baseline) | 
| Right Hip Range of Motion (transverse plane) | Mean peak degree of right hip external rotation across two 2-minute walking trials | Baseline | 
| Right Hip Range of Motion (transverse plane) | Mean peak degree of right hip external rotation across two 2-minute walking trials | end of treatment (8 weeks from Baseline) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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stroke, aerobic exercise, forced exercise, repetitive task practice, arm function, upper extremity