Clinical trial NCT00885456: Program of Rehabilitative Exercise and Education to Avert Vascular Events After Non-disabling Stroke or Transient Ischemic Attack: A Multi-site RCT
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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Transient Ischemic Attack
Non-disabling Stroke
Keywords: stroke
secondary prevention
vascular risk
behavioral change
exercise
lifestyle modification
Lead sponsor: Nova Scotia Health Authority
Sponsor class: OTHER
Collaborators: name: Heart and Stroke Foundation of Canada
name: Canadian Institutes of Health Research (CIHR)
name: Canadian Stroke Network
First posted: 2009-04-22
Enrollment: 187
Sex: ALL
Minimum age (years): 17
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.


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.

Primary outcomes:
measure: systolic blood pressure (primary vascular risk factor being assessed)
timeFrame: baseline, post-intervention, 6 months, 12 months
measure: diastolic blood pressure
timeFrame: baseline, post-intervention, 6 months, 12 months
measure: waist circumference
timeFrame: baseline, post-intervention, 6 months, 12 months
measure: 12-hour fasting lipid profile
timeFrame: baseline, post-intervention, 6 months, 12 months
measure: 12-hour fasting glucose/hemoglobin A1C
timeFrame: baseline, post-intervention, 6 months, 12 months
Secondary outcomes:
measure: exercise capacity
timeFrame: baseline, post-intervention, 12 months
measure: daily physical activity
timeFrame: baseline, post-intervention, 6 months, 12 months
measure: walking endurance
timeFrame: baseline, post-intervention, 6 months, 12 months
measure: cigarette smoking
timeFrame: baseline, post-intervention, 6 months, 12 months
measure: medication adherence
timeFrame: baseline, post-intervention, 6 months, 12 months
measure: cognition
timeFrame: baseline, 12 months
measure: depression
timeFrame: baseline, post-intervention, 6 months, 12 months
measure: health-related quality of life
timeFrame: baseline, post-intervention, 6 months, 12 months
measure: health-related goal attainment
timeFrame: baseline, post-intervention, 6 months, 12 months
measure: direct health costs
timeFrame: baseline, post-intervention, 6 months, 12 months
measure: secondary vascular events
timeFrame: baseline, post-intervention, 6 months, 12 months
measure: daily step count
timeFrame: baseline, post-intervention, 12 months
Other outcomes:
Locations:
city: Halifax
country: Canada
facility: Halifax Infirmary Site, QEII Health Sciences Centre
state: Nova Scotia
city: Kentville
country: Canada
facility: Annapolis Valley Regional Hospital
state: Nova Scotia
Study officials:
affiliation: Dalhousie University
name: Marilyn MacKay-Lyons, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.