Non-disabling Stroke, Transient Ischemic Attack
Conditions
Keywords
stroke, secondary prevention, vascular risk, behavioral change, exercise, lifestyle modification
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.
Interventions
BEHAVIORALPREVENT program
12-week program of aerobic/strengthening exercises and education designed to induce physiological and behavioral changes deemed necessary to reduce vascular risk
BEHAVIORALUsual Care
Three or more out-patient visits to the neurovascular clinic for assessment, counseling and referral to appropriate health care professionals.
Sponsors
Heart and Stroke Foundation of Canada
Canadian Institutes of Health Research (CIHR)
Canadian Stroke Network
Marilyn MacKay-Lyons
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
17 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 12-hour fasting glucose/hemoglobin A1C | baseline, post-intervention, 6 months, 12 months |
| 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 |
Secondary
| Measure | Time frame |
|---|---|
| cognition | baseline, 12 months |
| depression | baseline, post-intervention, 6 months, 12 months |
| health-related quality of life | baseline, post-intervention, 6 months, 12 months |
| exercise capacity | baseline, post-intervention, 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 |
| health-related goal attainment | baseline, post-intervention, 6 months, 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 |
Countries
Canada
Outcome results
None listed