NCT00885456: PREVENT

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

Completed Phase 2 Last updated 23 March 2018

What this trial tests

Phase 2 trial testing PREVENT program in Transient Ischemic Attack in 187 participants. Completed in 30 June 2017.

Timeline

30 October 2011

Primary endpoint
30 June 2017

30 June 2017

Quick facts

Lead sponsor	Marilyn MacKay-Lyons
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	health services research
Enrollment	187
Start date	30 October 2011
Primary completion	30 June 2017
Estimated completion	30 June 2017
Sites	2 locations across Canada

Drugs / interventions tested

• PREVENT program
• Usual Care

Conditions studied

• Transient Ischemic Attack — all drugs for Transient Ischemic Attack →
• Non-disabling Stroke — all drugs for Non-disabling Stroke →

Sponsor

Marilyn MacKay-Lyons

Who can join

17 and older, any sex, with Transient Ischemic Attack or Non-disabling Stroke. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own 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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. 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.
   MacKay-Lyons M, Gubitz G, Giacomantonio N, Wightman H, et al · · 2010 · cited 29× · PMID 21143864 · DOI 10.1186/1471-2377-10-122
2. Program of Rehabilitative Exercise and Education to Avert Vascular Events After Non-Disabling Stroke or Transient Ischemic Attack (PREVENT Trial): A Randomized Controlled Trial.
   MacKay-Lyons M, Gubitz G, Phillips S, Giacomantonio N, et al · · 2022 · cited 13× · PMID 34788569 · DOI 10.1177/15459683211060345