Heart-Brain Retraining for Stroke Rehabilitation

Study Overview
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Brief Summary
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The purpose of this study is to gain a better understanding of how different types of exercise can help people after a stroke. The investigators want to study if different types of exercise will improve the use of arm and hand function after a stroke.

Detailed Description
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Stroke is the leading cause of disability in the United States with approximately 795,000 new or recurrent strokes per year. An estimated two thirds of patients post-stroke cannot incorporate the affected upper extremity (UE) into their activities of daily living. In addition, stroke survivors experience a 60% decrease in cardiovascular capacity, which contributed to disability and diminished quality of life. Developing rehabilitation techniques to optimize motor recovery while improving cardiovascular endurance would benefit the stroke population. Animal studies using a forced exercise (FE) paradigm, in which the rodent is exercised on a motorized treadmill at a rate greater than its voluntary rate, indicate an endogenous increase in neurotrophic factors such as brain-derived neurotrophic factor (BDNF) and glial-derived neurotrophic factor (GDNF). These neurotrophic factors are thought to underlie neuroplasticity and motor learning. It is hypothesized that patients with stroke, due to decreased motor cortical output, cannot sustain high rates of voluntary exercise necessary to trigger the endogenous release of neurotrophic factors; therefore, forced-exercise is necessary to augment their voluntary efforts and will be superior to voluntary exercise in facilitating motor recovery. When coupled with repetitive task practice (RTP) of the UE, an effective form of UE rehabilitation, FE will prime the brain for neuroplasticity. We have developed a safe and effective method of delivering forced-exercise to Parkinson's disease (PD) patients (NIH R21HD056316). Clinical and imaging data with PD patients indicate forced-exercise, but not voluntary exercise, triggers a neurophysiologic response in the central nervous system resulting in global improvements in motor and non-motor functioning and increased cortical and subcortical activation. The aim of this project is to conduct a preliminary trial to compare the effects of forced to voluntary exercise when coupled with RTP in promoting the recovery of motor function in patients with stroke.

Official Title
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Heart-Brain Retraining: Forced Aerobic Exercise for Stroke Rehabilitation

Conditions
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Stroke

Intervention / Treatment
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* Behavioral: Repetitive Task Practice (RTP)
* Behavioral: Voluntary cycling + RTP
* Behavioral: Assisted cycling + RTP


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Able to provide informed consent Within 6-12 months of diagnosis of single ischemic or hemorrhagic stroke, confirmed with neuroimaging Fugl-Meyer Motor Score 19-55 in involved upper extremity Approval from patient's primary care physician Age between 18 and 85 years Exclusion Criteria: Hospitalization for myocardial infarction, congestive heart failure, or heart surgery (CABG or valve replacement) within 3 months of study enrollment Serious cardiac arrhythmia Hypertrophic cardiomyopathy Severe aortic stenosis Cardiac pacemaker Pulmonary embolus Other medical or musculoskeletal contraindication to exercise Significant cognitive impairment (unable to follow 1-2 step commands) or major psychiatric disorder (major depression, generalized anxiety) that will cause difficulty in study participation Anti-spasticity injection (botox) in upper extremity within 3 months of study enrollment Pregnancy

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: Repetitive Task Practice (RTP)<br>This group focuses on RTP. | Behavioral: Repetitive Task Practice (RTP)<br>* This group will preform arm and hand therapy.<br>|
| Experimental: Voluntary cycling + RTP<br>This group involves one biking session and one RTP session three times per week for eight weeks. | Behavioral: Voluntary cycling + RTP<br>* This group will preform arm and hand therapy and cycle on a bike.<br>|
| Experimental: Assisted cycling + RTP<br>This group involves one biking session and one RTP session three times per week for eight weeks. | Behavioral: Assisted cycling + RTP<br>* This group will preform arm and hand therapy and cycle on a bike.<br>|

What is the study measuring?
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Primary 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 UE and the unaffected UE. Total Functional Ability Score is reported, scores range from 0-75, with higher scores indicating a better outcome. | Baseline, End of Treatment (8 weeks); End of Treatment + 4 week (12 weeks) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Fugl-Meyer Assessment (FMA) | This is a 33 item assessment of post-stroke UE impairment. Total score is reported, scores range from 0-66, with higher scores indicating a better outcome. | Baseline, End of Treatment (8 weeks); End of Treatment + 4 week (12 weeks) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Stroke, Exercise, Rehabilitation, Neuroplasticity, Task Practice