Effectiveness of a Program of Rehabilitative Exercise and Education to Avert Vascular Events After Non-disabling Stroke: A Multi-site RCT
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Transient Ischemic Attack
- Sponsor
- Marilyn MacKay-Lyons
- Enrollment
- 187
- Locations
- 2
- Primary Endpoint
- diastolic blood pressure
- Status
- Completed
- Last Updated
- 8 years ago
Overview
Brief Summary
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.
Investigators
Marilyn MacKay-Lyons
Affiliated Scientist
Nova Scotia Health Authority
Eligibility Criteria
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.
Outcomes
Primary Outcomes
diastolic blood pressure
Time Frame: baseline, post-intervention, 6 months, 12 months
systolic blood pressure (primary vascular risk factor being assessed)
Time Frame: baseline, post-intervention, 6 months, 12 months
waist circumference
Time Frame: baseline, post-intervention, 6 months, 12 months
12-hour fasting glucose/hemoglobin A1C
Time Frame: baseline, post-intervention, 6 months, 12 months
12-hour fasting lipid profile
Time Frame: baseline, post-intervention, 6 months, 12 months
Secondary Outcomes
- walking endurance(baseline, post-intervention, 6 months, 12 months)
- cigarette smoking(baseline, post-intervention, 6 months, 12 months)
- exercise capacity(baseline, post-intervention, 12 months)
- daily physical activity(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)
- medication adherence(baseline, post-intervention, 6 months, 12 months)
- daily step count(baseline, post-intervention, 12 months)