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

Enrolling by invitation

Phase 2 Results N/A

Trial Description

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.

Conditions

Interventions

  • PREVENT Program Behavioral
    Intervention Desc: 12-week program of aerobic/strengthening exercises and education designed to induce physiological and behavioral changes deemed necessary to reduce vascular risk
    ARM 1: Kind: Experimental
    Label: PREVENT program
    Description: 12-week program of exercise and education to induce physiological and behavioral changes needed to reduce vascular risk factors.
  • Usual care Other
    Intervention Desc: Three or more out-patient visits to the neurovascular clinic for assessment, counseling and referral to appropriate health care professionals.
    ARM 1: Kind: Experimental
    Label: Usual Care
    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

Trial Design

  • Allocation: Randomized
  • Masking: Single Blind (Outcomes Assessor)
  • Purpose: Health Services Research
  • Endpoint: Efficacy Study
  • Intervention: Parallel Assignment

Patient Involvement

Patients will be randomized to one of two arms: PREVENT program: Experimental 12-week program of exercise and education to induce physiological and behavioral changes needed to reduce vascular risk factors and Behavioral: PREVENT program of 12-weeks of aerobic/strengthening exercises and education designed to induce physiological and behavioral changes deemed necessary to reduce vascular risk Usual Care: Active Comparator of an 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 and Behavioral: Usual Care ofthree or more out-patient visits to the neurovascular clinic for assessment, counseling and referral to appropriate health care professionals. In addition, patients will have systolic blood pressure, diastolic blood pressure, waist circumference, 12-hour fasting lipid profile, 12-hour fasting glucose/hemoglobin A1C, exercise capacity, daily physical activity, walking endurance, cigarette smoking, medication adherence, cognition, depression, health-related quality of life, health-related goal attainment, direct health costs, & secondary vascular events assessed at baseline, 3 months, 6 months & 12 months.

Outcomes

Type Measure Time Frame Safety Issue
Primary Systolic blood pressure, diastolic blood pressure, waist circumference, 12-hour fasting lipid profile, & 12-hour fasting glucose/hemoglobin A1C.
Secondary exercise capacity, daily physical activity, walking endurance, cigarette smoking, medication adherence, cognition, depression, health-related quality of life, health-related goal attainment, direct health costs, & secondary vascular events.
Primary systolic blood pressure (primary vascular risk factor being assessed) baseline, 3 months, 6 months, 12 months No
Primary diastolic blood pressure baseline, 3 months, 6 months, 12 months No
Primary waist circumference baseline, 3 months, 6 months, 12 months No
Primary 12-hour fasting lipid profile baseline, 3 months, 6 months, 12 months No
Primary 12-hour fasting glucose/hemoglobin A1C baseline, 3 months, 6 months, 12 months No
Secondary exercise capacity baseline, 3 months, 12 months No
Secondary daily physical activity baseline, 3 months, 6 months, 12 months No
Secondary walking endurance baseline, 3 months, 6 months, 12 months No
Secondary cigarette smoking baseline, 3 months, 6 months, 12 months No
Secondary medication adherence baseline, 3 months, 6 months, 12 months No
Secondary cognition baseline, 12 months No
Secondary depression baseline, 3 months, 6 months, 12 months No
Secondary health-related quality of life baseline, 3 months, 6 months, 12 months No
Secondary health-related goal attainment baseline, 3 months, 6 months, 12 months No
Secondary direct health costs baseline, 3 months, 6 months, 12 months No
Secondary secondary vascular events baseline, 3 months, 6 months, 12 months No
Secondary daily step count baseline, post-intervention, 12 months No

Sponsors