Cost-effectiveness of Forced Aerobic Exercise for Stroke Rehabilitation

Sponsor

The Cleveland Clinic (Other)

Overall Status

Recruiting

CT.gov ID

NCT03819764

Collaborator

(none)

Enrollment

Location

Arms

51.7

Anticipated Duration (Months)

1.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Stroke Cerebrovascular Disorders Brain Diseases Central Nervous System Diseases Nervous System Diseases Vascular Diseases Cardiovascular Diseases	Behavioral: Aerobic Exercise Behavioral: Upper Extremity Repetitive Task Practice	N/A

Detailed Description

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Apr 11, 2019

Anticipated Primary Completion Date :

Aug 1, 2023

Anticipated Study Completion Date :

Aug 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Aerobic Exercise & Repetitive Task Practice Participants will perform the following: 45 minutes of cycling 45 minutes of upper extremity repetitive arm exercises	Behavioral: Aerobic Exercise 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 Behavioral: Upper Extremity Repetitive Task Practice Repetitive arm exercises
Active Comparator: Upper Extremity Repetitive Task Practice Only Participants will perform the following: 1. 90 minutes of upper extremity repetitive arm exercises	Behavioral: Upper Extremity Repetitive Task Practice Repetitive arm exercises

Arm

Intervention/Treatment

Active Comparator: Aerobic Exercise & Repetitive Task Practice

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

Behavioral: Aerobic Exercise

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

Behavioral: Upper Extremity Repetitive Task Practice

Repetitive arm exercises

Active Comparator: Upper Extremity Repetitive Task Practice Only

Participants will perform the following: 1. 90 minutes of upper extremity repetitive arm exercises

Behavioral: Upper Extremity Repetitive Task Practice

Repetitive arm exercises

Outcome Measures

Primary Outcome Measures

Fugl-Meyer Assessment (FMA) [Baseline]
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.
Fugl-Meyer Assessment (FMA) [midpoint (4 weeks from Baseline)]
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.
Fugl-Meyer Assessment (FMA) [end of treatment (8 weeks from Baseline)]
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.
Fugl-Meyer Assessment (FMA) [end of treatment +4 weeks (12 weeks from Baseline)]
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.
Fugl-Meyer Assessment (FMA) [end of treatment +6 months (8 months from Baseline)]
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.
Fugl-Meyer Assessment (FMA) [end of treatment +1 year (14 months from Baseline)]
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.
Action Research Arm Test (ARAT) [Baseline]
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.
Action Research Arm Test (ARAT) [end of treatment (8 weeks from Baseline)]
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.
Action Research Arm Test (ARAT) [end of treatment +4 weeks (12 weeks from Baseline)]
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.
Action Research Arm Test (ARAT) [end of treatment +6 months (8 months from Baseline)]
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.
Action Research Arm Test (ARAT) [end of treatment +1 year (14 months from Baseline)]
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.

Secondary Outcome Measures

Wolf Motor Function Test (WMFT) [Baseline]
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.
Wolf Motor Function Test (WMFT) [end of treatment (8 weeks from Baseline)]
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.
Stroke Impact Scale (SIS) [Baseline]
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.
Stroke Impact Scale (SIS) [end of treatment (8 weeks from Baseline)]
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.
Stroke Impact Scale (SIS) [end of treatment +6 months (8 months from Baseline)]
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.
Stroke Impact Scale (SIS) [end of treatment +1 year (14 months from Baseline)]
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.
Patient-Reported Outcomes Measurement Information System (PROMIS-29) [Baseline]
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.
Patient-Reported Outcomes Measurement Information System (PROMIS-29) [end of treatment (8 weeks from Baseline)]
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.
Patient-Reported Outcomes Measurement Information System (PROMIS-29) [end of treatment +6 months (8 months from Baseline)]
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.
Patient-Reported Outcomes Measurement Information System (PROMIS-29) [end of treatment +1 year (14 months from Baseline)]
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.
Center for Epidemiological Studies-Depression (CES-D) [Baseline]
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.
Center for Epidemiological Studies-Depression (CES-D) [end of treatment (8 weeks from Baseline)]
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.
Center for Epidemiological Studies-Depression (CES-D) [end of treatment +6 months (8 months from Baseline)]
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.
Center for Epidemiological Studies-Depression (CES-D) [end of treatment +1 year (14 months from Baseline)]
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.
Six-Minute Walk Test (6MWT) [Baseline]
Total distance (feet) traveled over a 6 minute period.
Six-Minute Walk Test (6MWT) [end of treatment (8 weeks)]
Total distance (feet) traveled over a 6 minute period.
Six-Minute Walk Test (6MWT) [end of treatment +4 weeks (12 weeks from Baseline)]
Total distance (feet) traveled over a 6 minute period.
Six-Minute Walk Test (6MWT) [end of treatment +6 months (8 months from Baseline)]
Total distance (feet) traveled over a 6 minute period.
Six-Minute Walk Test (6MWT) [end of treatment +1 year (14 months from Baseline)]
Total distance (feet) traveled over a 6 minute period.
Modified Rankin Scale [Baseline]
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.
Modified Rankin Scale [end of treatment (8 weeks from Baseline)]
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.
Modified Rankin Scale [end of treatment +6 months (8 months from Baseline)]
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.
Modified Rankin Scale [end of treatment +1 year (14 months from Baseline)]
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.
Right Step Length [Baseline]
Mean right step length (cm) across two 2-minute walking trials
Right Step Length [end of treatment (8 weeks from Baseline)]
Mean right step length (cm) across two 2-minute walking trials
Left Step Length [Baseline]
Mean left step length (cm) across two 2-minute walking trials
Left Step Length [end of treatment (8 weeks from Baseline)]
Mean left step length (cm) across two 2-minute walking trials
Right Step Width [Baseline]
Mean right step width (cm) across two 2-minute walking trials
Right Step Width [end of treatment (8 weeks from Baseline)]
Mean right step width (cm) across two 2-minute walking trials
Left Step Width [Baseline]
Mean left step width (cm) across two 2-minute walking trials
Left Step Width [end of treatment (8 weeks from Baseline)]
Mean left step width (cm) across two 2-minute walking trials
Right Stance Time [Baseline]
Mean time (in seconds) spent in stance phase on the right lower extremity across two 2-minute walking trials
Right Stance Time [end of treatment (8 weeks from Baseline)]
Mean time (in seconds) spent in stance phase on the right lower extremity across two 2-minute walking trials
Left Stance Time [Baseline]
Mean time (in seconds) spent in stance phase on the left lower extremity across two 2-minute walking trials
Left Stance Time [end of treatment (8 weeks from Baseline)]
Mean time (in seconds) spent in stance phase on the left lower extremity across two 2-minute walking trials
Right Swing Time [Baseline]
Mean time (in seconds) spent in swing phase on the right lower extremity across two 2-minute walking trials
Right Swing Time [end of treatment (8 weeks from Baseline)]
Mean time (in seconds) spent in swing phase on the right lower extremity across two 2-minute walking trials
Left Swing Time [Baseline]
Mean time (in seconds) spent in swing phase on the left lower extremity across two 2-minute walking trials
Left Swing Time [end of treatment (8 weeks from Baseline)]
Mean time (in seconds) spent in swing phase on the left lower extremity across two 2-minute walking trials
Walking Speed [Baseline]
Mean m/s across two 2-minute walking trials
Walking Speed [end of treatment (8 weeks from Baseline)]
Mean m/s across two 2-minute walking trials
Walking Cadence [Baseline]
Mean steps/minute across two 2-minute walking trials
Walking Cadence [end of treatment (8 weeks from Baseline)]
Mean steps/minute across two 2-minute walking trials
Left Knee Range of Motion [Baseline]
Mean peak degree of left knee flexion across two 2-minute walking trials
Left Knee Range of Motion [end of treatment (8 weeks from Baseline)]
Mean peak degree of left knee flexion across two 2-minute walking trials
Right Knee Range of Motion [Baseline]
Mean peak degree of right knee flexion across two 2-minute walking trials
Right Knee Range of Motion [end of treatment (8 weeks from Baseline)]
Mean peak degree of right knee flexion across two 2-minute walking trials
Left Ankle Range of Motion [Baseline]
Mean peak degree of left ankle dorsiflexion across two 2-minute walking trials
Left Ankle Range of Motion [end of treatment (8 weeks from Baseline)]
Mean peak degree of left ankle dorsiflexion across two 2-minute walking trials
Right Ankle Range of Motion [Baseline]
Mean peak degree of right ankle dorsiflexion across two 2-minute walking trials
Right Ankle Range of Motion [end of treatment (8 weeks from Baseline)]
Mean peak degree of right ankle dorsiflexion across two 2-minute walking trials
Left Hip Range of Motion (sagittal plane) [Baseline]
Mean peak degree of left hip flexion across two 2-minute walking trials
Left Hip Range of Motion (sagittal plane) [end of treatment (8 weeks from Baseline)]
Mean peak degree of left hip flexion across two 2-minute walking trials
Right Hip Range of Motion (sagittal plane) [Baseline]
Mean peak degree of right hip flexion across two 2-minute walking trials
Right Hip Range of Motion (sagittal plane) [end of treatment (8 weeks from Baseline)]
Mean peak degree of right hip flexion across two 2-minute walking trials
Left Hip Range of Motion (coronal plane) [Baseline]
Mean peak degree of left hip abduction across two 2-minute walking trials
Left Hip Range of Motion (coronal plane) [end of treatment (8 weeks from Baseline)]
Mean peak degree of left hip abduction across two 2-minute walking trials
Right Hip Range of Motion (coronal plane) [Baseline]
Mean peak degree of right hip abduction across two 2-minute walking trials
Right Hip Range of Motion (coronal plane) [end of treatment (8 weeks from Baseline)]
Mean peak degree of right hip abduction across two 2-minute walking trials
Left Hip Range of Motion (transverse plane) [Baseline]
Mean peak degree of left hip external rotation across two 2-minute walking trials
Left Hip Range of Motion (transverse plane) [end of treatment (8 weeks from Baseline)]
Mean peak degree of left hip external rotation across two 2-minute walking trials
Right Hip Range of Motion (transverse plane) [Baseline]
Mean peak degree of right hip external rotation across two 2-minute walking trials
Right Hip Range of Motion (transverse plane) [end of treatment (8 weeks from Baseline)]
Mean peak degree of right hip external rotation across two 2-minute walking trials

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 85 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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