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NCT Number: NCT00885456

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

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.

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Key information

Conditions

Transient Ischemic Attack Behavior Brain Diseases Brain Ischemia Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Ischemic Attack, Transient Motor Activity Nervous System Diseases Non-disabling Stroke Stroke Vascular Diseases

Age range

17 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Halifax Infirmary Site, QEII Health Sciences Centre, Halifax, Nova Scotia, Canada

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

PREVENT Program

Behavioral

12-week program of aerobic/strengthening exercises and education designed to induce physiological and behavioral changes deemed necessary to reduce vascular risk

Usual Care

Behavioral

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

Primary outcomes

  1. systolic blood pressure (primary vascular risk factor being assessed)

    Time frame: baseline, post-intervention, 6 months, 12 months

  2. diastolic blood pressure

    Time frame: baseline, post-intervention, 6 months, 12 months

  3. waist circumference

    Time frame: baseline, post-intervention, 6 months, 12 months

  4. 12-hour fasting lipid profile

    Time frame: baseline, post-intervention, 6 months, 12 months

  5. 12-hour fasting glucose/hemoglobin A1C

    Time frame: baseline, post-intervention, 6 months, 12 months

Secondary outcomes

  1. exercise capacity

    Time frame: baseline, post-intervention, 12 months

  2. daily physical activity

    Time frame: baseline, post-intervention, 6 months, 12 months

  3. walking endurance

    Time frame: baseline, post-intervention, 6 months, 12 months

  4. cigarette smoking

    Time frame: baseline, post-intervention, 6 months, 12 months

  5. medication adherence

    Time frame: baseline, post-intervention, 6 months, 12 months

  6. cognition

    Time frame: baseline, 12 months

  7. depression

    Time frame: baseline, post-intervention, 6 months, 12 months

  8. health-related quality of life

    Time frame: baseline, post-intervention, 6 months, 12 months

  9. health-related goal attainment

    Time frame: baseline, post-intervention, 6 months, 12 months

  10. direct health costs

    Time frame: baseline, post-intervention, 6 months, 12 months

  11. secondary vascular events

    Time frame: baseline, post-intervention, 6 months, 12 months

  12. daily step count

    Time frame: baseline, post-intervention, 12 months

Sponsors and collaborators

Lead sponsor

Marilyn MacKay-Lyons

Other

Collaborators

  • Canadian Institutes of Health Research (CIHR)
  • Canadian Stroke Network
  • Heart and Stroke Foundation of Canada

Registry information

Official study title

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

Acronym: PREVENT

Important dates

Study start
2011
Primary completion
2017
Study completion
2017
First posted
Apr 22, 2009
Registry last updated
Mar 23, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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