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

This study is enrolling participants by invitation only.
Sponsor:
Collaborators:
Heart and Stroke Foundation of Canada
Canadian Institutes of Health Research (CIHR)
Canadian Stroke Network
Information provided by (Responsible Party):
Marilyn MacKay-Lyons, Capital District Health Authority, Canada
ClinicalTrials.gov Identifier:
NCT00885456
First received: April 21, 2009
Last updated: August 24, 2012
Last verified: August 2012
  Purpose

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.


Condition Intervention Phase
Transient Ischemic Attack
Non-disabling Stroke
Behavioral: PREVENT program
Behavioral: Usual Care
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Health Services Research
Official Title: Effectiveness of a Program of Rehabilitative Exercise and Education to Avert Vascular Events After Non-disabling Stroke: A Multi-site RCT

Resource links provided by NLM:


Further study details as provided by Capital District Health Authority, Canada:

Primary Outcome Measures:
  • systolic blood pressure (primary vascular risk factor being assessed) [ Time Frame: baseline, post-intervention, 6 months, 12 months ] [ Designated as safety issue: No ]
  • diastolic blood pressure [ Time Frame: baseline, post-intervention, 6 months, 12 months ] [ Designated as safety issue: No ]
  • waist circumference [ Time Frame: baseline, post-intervention, 6 months, 12 months ] [ Designated as safety issue: No ]
  • 12-hour fasting lipid profile [ Time Frame: baseline, post-intervention, 6 months, 12 months ] [ Designated as safety issue: No ]
  • 12-hour fasting glucose/hemoglobin A1C [ Time Frame: baseline, post-intervention, 6 months, 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • exercise capacity [ Time Frame: baseline, post-intervention, 12 months ] [ Designated as safety issue: No ]
  • daily physical activity [ Time Frame: baseline, post-intervention, 6 months, 12 months ] [ Designated as safety issue: No ]
  • walking endurance [ Time Frame: baseline, post-intervention, 6 months, 12 months ] [ Designated as safety issue: No ]
  • cigarette smoking [ Time Frame: baseline, post-intervention, 6 months, 12 months ] [ Designated as safety issue: No ]
  • medication adherence [ Time Frame: baseline, post-intervention, 6 months, 12 months ] [ Designated as safety issue: No ]
  • cognition [ Time Frame: baseline, 12 months ] [ Designated as safety issue: No ]
  • depression [ Time Frame: baseline, post-intervention, 6 months, 12 months ] [ Designated as safety issue: No ]
  • health-related quality of life [ Time Frame: baseline, post-intervention, 6 months, 12 months ] [ Designated as safety issue: No ]
  • health-related goal attainment [ Time Frame: baseline, post-intervention, 6 months, 12 months ] [ Designated as safety issue: No ]
  • direct health costs [ Time Frame: baseline, post-intervention, 6 months, 12 months ] [ Designated as safety issue: No ]
  • secondary vascular events [ Time Frame: baseline, post-intervention, 6 months, 12 months ] [ Designated as safety issue: No ]
  • daily step count [ Time Frame: baseline, post-intervention, 12 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 250
Study Start Date: September 2009
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: PREVENT program
12-week program of exercise and education to induce physiological and behavioral changes needed to reduce vascular risk factors.
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
Active Comparator: Usual Care
Average of three visits to the Neurovascular Clinic for a neurological and health assessment, counseling regarding stroke/TIA and diagnostic test results, and assessment, modification and education of secondary prevention factors
Behavioral: Usual Care
Three or more out-patient visits to the neurovascular clinic for assessment, counseling and referral to appropriate health care professionals.

  Eligibility

Ages Eligible for Study:   17 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00885456

Locations
Canada, Nova Scotia
Halifax Infirmary Site, QEII Health Sciences Centre
Halifax, Nova Scotia, Canada, B3H 3A7
Annapolis Valley Regional Hospital
Kentville, Nova Scotia, Canada, B4N 5E3
Sponsors and Collaborators
Capital District Health Authority, Canada
Heart and Stroke Foundation of Canada
Canadian Institutes of Health Research (CIHR)
Canadian Stroke Network
Investigators
Principal Investigator: Marilyn MacKay-Lyons, PhD Dalhousie University
  More Information

No publications provided by Capital District Health Authority, Canada

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Marilyn MacKay-Lyons, Affiliated Scientist, Capital District Health Authority, Canada
ClinicalTrials.gov Identifier: NCT00885456     History of Changes
Other Study ID Numbers: PREVENT Trial
Study First Received: April 21, 2009
Last Updated: August 24, 2012
Health Authority: Canada: Canadian Institutes of Health Research
Canada: Ethics Review Committee

Keywords provided by Capital District Health Authority, Canada:
stroke
secondary prevention
vascular risk
behavioral change
exercise
lifestyle modification

Additional relevant MeSH terms:
Ischemic Attack, Transient
Ischemia
Brain Ischemia
Stroke
Cerebral Infarction
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Pathologic Processes
Brain Infarction

ClinicalTrials.gov processed this record on August 25, 2014