Cost-effectiveness of Forced Aerobic Exercise for Stroke Rehabilitation

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

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.

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.

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

Participants will perform the following: 45 minutes of cycling 45 minutes of upper extremity repetitive arm exercises

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

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

Mean time (in seconds) spent in stance phase on the right lower extremity across two 2-minute walking trials

Mean time (in seconds) spent in stance phase on the right lower extremity across two 2-minute walking trials

Mean time (in seconds) spent in stance phase on the left lower extremity across two 2-minute walking trials

Mean time (in seconds) spent in stance phase on the left lower extremity across two 2-minute walking trials

Mean time (in seconds) spent in swing phase on the right lower extremity across two 2-minute walking trials

Mean time (in seconds) spent in swing phase on the right lower extremity across two 2-minute walking trials

Mean time (in seconds) spent in swing phase on the left lower extremity across two 2-minute walking trials

Mean time (in seconds) spent in swing phase on the left lower extremity across two 2-minute walking trials

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