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

Transient Ischemic Attack Clinical Trial

— PREVENT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00885456
• Other study ID #: PREVENT Trial
• Status: Completed
• Phase: Phase 2
• First received: April 21, 2009
• Last updated: March 21, 2018
• Start date: October 30, 2011
• Est. completion date: June 30, 2017

Study information

• Verified date: March 2018
• Source: Nova Scotia Health Authority
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 187
• Est. completion date: June 30, 2017
• Est. primary completion date: June 30, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 17 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Ischemia
• Ischemic Attack, Transient
• Non-disabling Stroke
• Stroke
• Transient Ischemic Attack

Intervention

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
• Usual Care
Three or more out-patient visits to the neurovascular clinic for assessment, counseling and referral to appropriate health care professionals.

Locations

Country	Name	City	State
Canada	Halifax Infirmary Site, QEII Health Sciences Centre	Halifax	Nova Scotia
Canada	Annapolis Valley Regional Hospital	Kentville	Nova Scotia

Sponsors (4)

Lead Sponsor	Collaborator
Marilyn MacKay-Lyons	Canadian Institutes of Health Research (CIHR), Canadian Stroke Network, Heart and Stroke Foundation of Canada

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	systolic blood pressure (primary vascular risk factor being assessed)		baseline, post-intervention, 6 months, 12 months
Primary	diastolic blood pressure		baseline, post-intervention, 6 months, 12 months
Primary	waist circumference		baseline, post-intervention, 6 months, 12 months
Primary	12-hour fasting lipid profile		baseline, post-intervention, 6 months, 12 months
Primary	12-hour fasting glucose/hemoglobin A1C		baseline, post-intervention, 6 months, 12 months
Secondary	exercise capacity		baseline, post-intervention, 12 months
Secondary	daily physical activity		baseline, post-intervention, 6 months, 12 months
Secondary	walking endurance		baseline, post-intervention, 6 months, 12 months
Secondary	cigarette smoking		baseline, post-intervention, 6 months, 12 months
Secondary	medication adherence		baseline, post-intervention, 6 months, 12 months
Secondary	cognition		baseline, 12 months
Secondary	depression		baseline, post-intervention, 6 months, 12 months
Secondary	health-related quality of life		baseline, post-intervention, 6 months, 12 months
Secondary	health-related goal attainment		baseline, post-intervention, 6 months, 12 months
Secondary	direct health costs		baseline, post-intervention, 6 months, 12 months
Secondary	secondary vascular events		baseline, post-intervention, 6 months, 12 months
Secondary	daily step count		baseline, post-intervention, 12 months