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

Phase 2

Completed

• Conditions: Transient Ischemic Attack; Non-disabling Stroke
• Interventions: Behavioral: Usual Care; Behavioral: PREVENT program

• Registration Number: NCT00885456
• Lead Sponsor: Marilyn MacKay-Lyons

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2009-04-21
• Study First Submitted QC: 2009-04-21
• Study First Posted: 2009-04-22
• Study Start: 2011-10-30
• Primary Completion: 2017-06-30
• Study Completion: 2017-06-30
• Status Verified: 2018-03
• Last Update Submitted: 2018-03-21
• Last Update Posted: 2018-03-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 187

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Usual Care	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
PREVENT program	PREVENT program	12-week program of exercise and education to induce physiological and behavioral changes needed to reduce vascular risk factors.

Primary Outcome Measures

Name	Time	Method
diastolic blood pressure	baseline, post-intervention, 6 months, 12 months
systolic blood pressure (primary vascular risk factor being assessed)	baseline, post-intervention, 6 months, 12 months
waist circumference	baseline, post-intervention, 6 months, 12 months
12-hour fasting glucose/hemoglobin A1C	baseline, post-intervention, 6 months, 12 months
12-hour fasting lipid profile	baseline, post-intervention, 6 months, 12 months

Secondary Outcome Measures

Name	Time	Method
daily step count	baseline, post-intervention, 12 months
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

Trial Locations

Locations (2)

Halifax Infirmary Site, QEII Health Sciences Centre; 🇨🇦 Halifax, Nova Scotia, Canada

Annapolis Valley Regional Hospital; 🇨🇦 Kentville, Nova Scotia, Canada