Testing Adaptive Physical Activity in Stroke

Study Overview
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Brief Summary
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Testing Adaptive Physical Activity in Stroke tests the idea that adaptive physical activity (APA) will improve fitness, balance and walking function, daily step activity, and outcomes related to quality of life in individuals with chronic stroke. Adaptive physical activity is an exercise model that combines aerobic exercise with balance and gait training in a socially reinforcing group setting. Individualized homework assignments encourage integration of exercise into daily life routines. Our specific aims are: to determine whether APA improves cardiovascular fitness and metabolic health to measure the effects of APA on gait and balance, ambulatory activity, and ADL function to determine whether APA affects self-reported outcomes related to self-efficacy, fatigue, and stroke-specific quality of life

Official Title
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Testing Adaptive Physical Activity in Stroke

Conditions
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Stroke

Intervention / Treatment
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* Other: Adaptive Physical Activity


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Ischemic stroke greater than or equal to 6 months prior in men or women ages 40- or older. Hemorrhagic stroke greater than or equal to one year prior in men or women ages 40-or older. Residual hemiparetic gait deficits. Already completed all conventional inpatient and outpatient physical therapy. Adequate language and neurocognitive function to participate in exercise testing and training (specific screening instruments used.)

Ages Eligible for Study
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Minimum Age: 40 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Home Exercise Only<br>Participants receive education and instruction on a home exercise program which they do on their own, with intermittent encouragement from study personnel. | Other: Adaptive Physical Activity<br>* Structured gait, balance, and progressive walking program performed in a group gym setting 3x/week for 6 months<br>|
| Experimental: APA<br>Participants exercise in a gym setting 3x/week for six months, performing gait and balance exercises along with a progressive walking program. | Other: Adaptive Physical Activity<br>* Structured gait, balance, and progressive walking program performed in a group gym setting 3x/week for 6 months<br>|
| Experimental: APA+TM<br>Participants exercise in a gym setting 3x/week for six months, performing a combined program of adaptive physical activity (gait and balance training) and progressive treadmill walking. | Other: Adaptive Physical Activity<br>* Structured gait, balance, and progressive walking program performed in a group gym setting 3x/week for 6 months<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| VO2 Peak |  | baseline, 3 months, 6 months, and 3 months post-intervention | 
| Berg Balance Scale |  | baseline, 3 months, 6 months, and 3 months post-intervention | 
| Dynamic Gait Index |  | Baseline, 3 months, 6 months, and 3 months post intervention | 
| Step Activity Monitoring |  | Baseline, 3 months, 6 months, and 3 months post-intervention | 
| 6 Minute Walks |  | Baseline, 3 months, 6 months, and 3 months post-intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Psychosocial questionnaires |  | baseline, 3 months, 6 months, and 3 months post-intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Stroke, Exercise, Balance, Dynamic Gait, Cardiovascular Fitness