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

Marilyn MacKay-Lyons

Status and phase: Completed; Phase 2

Conditions: Transient Ischemic Attack; Non-disabling Stroke

Treatments: Behavioral: PREVENT program; Behavioral: Usual Care

Study type: Interventional

Funder types: Other

Identifiers

NCT00885456

PREVENT Trial

Details and patient eligibility

About

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.

Enrollment: 187 patients

Sex: All

Ages: 17+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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187 participants in 2 patient groups

PREVENT program

Experimental group

Description:

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

Treatment:

Behavioral: PREVENT program

Usual Care

Active Comparator group

Description:

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

Treatment:

Behavioral: Usual Care