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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

187 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-10-30

Study Completion Date

2017-06-30

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.

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Detailed Description

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Conditions

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Transient Ischemic Attack Non-disabling Stroke

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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PREVENT program

12-week program of exercise and education to induce physiological and behavioral changes needed to reduce vascular risk factors.

Group Type EXPERIMENTAL

PREVENT program

Intervention Type BEHAVIORAL

12-week program of aerobic/strengthening exercises and education designed to induce physiological and behavioral changes deemed necessary to reduce vascular risk

Usual Care

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

Group Type ACTIVE_COMPARATOR

Usual Care

Intervention Type BEHAVIORAL

Three or more out-patient visits to the neurovascular clinic for assessment, counseling and referral to appropriate health care professionals.

Interventions

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PREVENT program

12-week program of aerobic/strengthening exercises and education designed to induce physiological and behavioral changes deemed necessary to reduce vascular risk

Intervention Type BEHAVIORAL

Usual Care

Three or more out-patient visits to the neurovascular clinic for assessment, counseling and referral to appropriate health care professionals.

Intervention Type BEHAVIORAL

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.

Minimum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No