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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00885456
Other study ID # PREVENT Trial
Secondary ID
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
Health authority
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.

Study Design


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
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