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

Primary Purpose

Transient Ischemic Attack, Non-disabling Stroke

Status
Completed
Phase
Phase 2
Locations
Canada
Study Type
Interventional
Intervention
PREVENT program
Usual Care
Sponsored by
Marilyn MacKay-Lyons
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Transient Ischemic Attack focused on measuring stroke, secondary prevention, vascular risk, behavioral change, exercise, lifestyle modification

Eligibility Criteria

17 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Halifax Infirmary Site, QEII Health Sciences Centre
  • Annapolis Valley Regional Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

PREVENT program

Usual Care

Arm Description

12-week program of exercise and education to induce physiological and behavioral changes needed to reduce vascular risk factors.

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

Outcomes

Primary Outcome Measures

systolic blood pressure (primary vascular risk factor being assessed)
diastolic blood pressure
waist circumference
12-hour fasting lipid profile
12-hour fasting glucose/hemoglobin A1C

Secondary Outcome Measures

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
daily step count

Full Information

First Posted
April 21, 2009
Last Updated
March 21, 2018
Sponsor
Marilyn MacKay-Lyons
Collaborators
Heart and Stroke Foundation of Canada, Canadian Institutes of Health Research (CIHR), Canadian Stroke Network
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1. Study Identification

Unique Protocol Identification Number
NCT00885456
Brief Title
Program of Rehabilitative Exercise and Education to Avert Vascular Events After Non-disabling Stroke or Transient Ischemic Attack: A Multi-site RCT
Acronym
PREVENT
Official Title
Effectiveness of a Program of Rehabilitative Exercise and Education to Avert Vascular Events After Non-disabling Stroke: A Multi-site RCT
Study Type
Interventional

2. Study Status

Record Verification Date
March 2018
Overall Recruitment Status
Completed
Study Start Date
October 30, 2011 (Actual)
Primary Completion Date
June 30, 2017 (Actual)
Study Completion Date
June 30, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Marilyn MacKay-Lyons
Collaborators
Heart and Stroke Foundation of Canada, Canadian Institutes of Health Research (CIHR), Canadian Stroke Network

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Transient Ischemic Attack, Non-disabling Stroke
Keywords
stroke, secondary prevention, vascular risk, behavioral change, exercise, lifestyle modification

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
187 (Actual)

8. Arms, Groups, and Interventions

Arm Title
PREVENT program
Arm Type
Experimental
Arm Description
12-week program of exercise and education to induce physiological and behavioral changes needed to reduce vascular risk factors.
Arm Title
Usual Care
Arm Type
Active Comparator
Arm 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
Intervention Type
Behavioral
Intervention Name(s)
PREVENT program
Intervention Description
12-week program of aerobic/strengthening exercises and education designed to induce physiological and behavioral changes deemed necessary to reduce vascular risk
Intervention Type
Behavioral
Intervention Name(s)
Usual Care
Intervention Description
Three or more out-patient visits to the neurovascular clinic for assessment, counseling and referral to appropriate health care professionals.
Primary Outcome Measure Information:
Title
systolic blood pressure (primary vascular risk factor being assessed)
Time Frame
baseline, post-intervention, 6 months, 12 months
Title
diastolic blood pressure
Time Frame
baseline, post-intervention, 6 months, 12 months
Title
waist circumference
Time Frame
baseline, post-intervention, 6 months, 12 months
Title
12-hour fasting lipid profile
Time Frame
baseline, post-intervention, 6 months, 12 months
Title
12-hour fasting glucose/hemoglobin A1C
Time Frame
baseline, post-intervention, 6 months, 12 months
Secondary Outcome Measure Information:
Title
exercise capacity
Time Frame
baseline, post-intervention, 12 months
Title
daily physical activity
Time Frame
baseline, post-intervention, 6 months, 12 months
Title
walking endurance
Time Frame
baseline, post-intervention, 6 months, 12 months
Title
cigarette smoking
Time Frame
baseline, post-intervention, 6 months, 12 months
Title
medication adherence
Time Frame
baseline, post-intervention, 6 months, 12 months
Title
cognition
Time Frame
baseline, 12 months
Title
depression
Time Frame
baseline, post-intervention, 6 months, 12 months
Title
health-related quality of life
Time Frame
baseline, post-intervention, 6 months, 12 months
Title
health-related goal attainment
Time Frame
baseline, post-intervention, 6 months, 12 months
Title
direct health costs
Time Frame
baseline, post-intervention, 6 months, 12 months
Title
secondary vascular events
Time Frame
baseline, post-intervention, 6 months, 12 months
Title
daily step count
Time Frame
baseline, post-intervention, 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marilyn MacKay-Lyons, PhD
Organizational Affiliation
Dalhousie University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Halifax Infirmary Site, QEII Health Sciences Centre
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3H 3A7
Country
Canada
Facility Name
Annapolis Valley Regional Hospital
City
Kentville
State/Province
Nova Scotia
ZIP/Postal Code
B4N 5E3
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
34788569
Citation
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.
Results Reference
derived
PubMed Identifier
21143864
Citation
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.
Results Reference
derived

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

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