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

Effectiveness of a Program of Rehabilitative Exercise and Education to Avert Vascular Events After Non-disabling Stroke: A Multi-site RCT

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.

Study Overview

• Status: Completed
• Conditions: Transient Ischemic Attack; Non-disabling Stroke
• Intervention / Treatment: Behavioral: PREVENT program; Behavioral: Usual Care

• Study Type: Interventional
• Enrollment (Actual): 187
• Phase: Phase 2

Contacts and Locations

Study Locations

• Canada
  • Nova Scotia
    • Halifax, Nova Scotia, Canada, B3H 3A7
      • Halifax Infirmary Site, QEII Health Sciences Centre
    • Kentville, Nova Scotia, Canada, B4N 5E3
      • Annapolis Valley Regional Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 17 years and older (ADULT, OLDER_ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: HEALTH_SERVICES_RESEARCH
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: PREVENT program; 12-week program of exercise and education to induce physiological and behavioral changes needed to reduce vascular risk factors.	Behavioral: PREVENT program; 12-week program of aerobic/strengthening exercises and education designed to induce physiological and behavioral changes deemed necessary to reduce vascular risk
ACTIVE_COMPARATOR: 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	Behavioral: Usual Care; Three or more out-patient visits to the neurovascular clinic for assessment, counseling and referral to appropriate health care professionals.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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
12-hour fasting glucose/hemoglobin A1C	baseline, post-intervention, 6 months, 12 months

Secondary Outcome Measures

Outcome Measure	Time Frame
exercise capacity	baseline, post-intervention, 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
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
daily step count	baseline, post-intervention, 12 months

Collaborators and Investigators

• Sponsor: Marilyn MacKay-Lyons
• Collaborators: Canadian Institutes of Health Research (CIHR); Heart and Stroke Foundation of Canada; Canadian Stroke Network

Publications and helpful links

General Publications

• MacKay-Lyons M, Gubitz G, Phillips S, Giacomantonio N, Firth W, Thompson K, Theriault C, Wightman H, Slipp S, Marsters D, Eskes G, Peacock F, Blanchard C, Dewolfe J. Program of Rehabilitative Exercise and Education to Avert Vascular Events After Non-Disabling Stroke or Transient Ischemic Attack (PREVENT Trial): A Randomized Controlled Trial. Neurorehabil Neural Repair. 2022 Feb;36(2):119-130. doi: 10.1177/15459683211060345. Epub 2021 Nov 17.
• MacKay-Lyons M, Gubitz G, Giacomantonio N, Wightman H, Marsters D, Thompson K, Blanchard C, Eskes G, Thornton M. Program of rehabilitative exercise and education to avert vascular events after non-disabling stroke or transient ischemic attack (PREVENT Trial): a multi-centred, randomised controlled trial. BMC Neurol. 2010 Dec 8;10:122. doi: 10.1186/1471-2377-10-122.

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 30, 2011
• Primary Completion (ACTUAL): June 30, 2017
• Study Completion (ACTUAL): June 30, 2017

Study Registration Dates

• First Submitted: April 21, 2009
• First Submitted That Met QC Criteria: April 21, 2009
• First Posted (ESTIMATE): April 22, 2009

Study Record Updates

• Last Update Posted (ACTUAL): March 23, 2018
• Last Update Submitted That Met QC Criteria: March 21, 2018
• Last Verified: March 1, 2018

More Information

Terms related to this study

• Keywords: exercise; stroke; secondary prevention; lifestyle modification; vascular risk; behavioral change
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Brain Ischemia; Stroke; Ischemia; Ischemic Attack, Transient
• Other Study ID Numbers: PREVENT Trial