Program of Rehabilitative Exercise and Education to Avert Vascular Events After Non-disabling Stroke or Transient Ischemic Attack: A Multi-site RCT

Study Overview
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Brief Summary
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The objective of the Program of Rehabilitative Exercise and Education to avert Vascular Events after Non-disabling stroke and Transient ischemic attack (PREVENT) Trial is to determine whether the timely delivery of secondary stroke prevention strategies will reduce modifiable vascular risk factors in two groups of people who have survived NDS or TIA. One group will receive a comprehensive education and exercise program (PREVENT); the other group will receive usual care (USUAL CARE). We will measure modifiable vascular risk factors in both groups. We will also compare the effects of PREVENT vs USUAL CARE on exercise capacity, walking endurance, and daily physical activity. In addition, we will compare thinking ability, depression, achievement of personal goals for healthy behavior, and health-related goal attainment and health-related quality of life. Finally, we will compare outcomes in urban and rural settings as well as costs of the PREVENT program and USUAL CARE in order to assess sustainability of the PREVENT program.

Official Title
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Effectiveness of a Program of Rehabilitative Exercise and Education to Avert Vascular Events After Non-disabling Stroke: A Multi-site RCT

Conditions
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Transient Ischemic Attack, Non-disabling Stroke

Intervention / Treatment
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* Behavioral: PREVENT program
* Behavioral: Usual Care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Males and females Over 17 years of age. Diagnosis of first probable or definite TIA or non-disabling stroke (National Institutes of Health Stroke Scale < 6) Post-event interval of <90 days. Residence within 75 km of intervention site. Orientation to time, place and person and ability to follow simple 3-step commands. Ability and willingness to provide informed consent. Exclusion Criteria: Evidence of intracranial hemorrhage on MRI or CT scan. Presence of contraindications to exercise testing and training, in accordance with American College of Sports Medicine Guidelines. Participation in another study that could potentially confound the outcomes of this trial.

Ages Eligible for Study
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Minimum Age: 17 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: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PREVENT program<br>12-week program of exercise and education to induce physiological and behavioral changes needed to reduce vascular risk factors. | Behavioral: PREVENT program<br>* 12-week program of aerobic/strengthening exercises and education designed to induce physiological and behavioral changes deemed necessary to reduce vascular risk<br>|
| Active Comparator: Usual Care<br>Average of three visits to the Neurovascular Clinic for a neurological and health assessment, counseling regarding stroke/TIA and diagnostic test results, and assessment, modification and education of secondary prevention factors | Behavioral: Usual Care<br>* Three or more out-patient visits to the neurovascular clinic for assessment, counseling and referral to appropriate health care professionals.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| systolic blood pressure (primary vascular risk factor being assessed) |  | baseline, post-intervention, 6 months, 12 months | 
| diastolic blood pressure |  | baseline, post-intervention, 6 months, 12 months | 
| waist circumference |  | baseline, post-intervention, 6 months, 12 months | 
| 12-hour fasting lipid profile |  | baseline, post-intervention, 6 months, 12 months | 
| 12-hour fasting glucose/hemoglobin A1C |  | baseline, post-intervention, 6 months, 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| exercise capacity |  | baseline, post-intervention, 12 months | 
| daily physical activity |  | baseline, post-intervention, 6 months, 12 months | 
| walking endurance |  | baseline, post-intervention, 6 months, 12 months | 
| cigarette smoking |  | baseline, post-intervention, 6 months, 12 months | 
| medication adherence |  | baseline, post-intervention, 6 months, 12 months | 
| cognition |  | baseline, 12 months | 
| depression |  | baseline, post-intervention, 6 months, 12 months | 
| health-related quality of life |  | baseline, post-intervention, 6 months, 12 months | 
| health-related goal attainment |  | baseline, post-intervention, 6 months, 12 months | 
| direct health costs |  | baseline, post-intervention, 6 months, 12 months | 
| secondary vascular events |  | baseline, post-intervention, 6 months, 12 months | 
| daily step count |  | baseline, post-intervention, 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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stroke, secondary prevention, vascular risk, behavioral change, exercise, lifestyle modification