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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: October 29, 2014
Last verified: October 2014

April 21, 2009
October 29, 2014
December 2009
December 2015   (final data collection date for primary outcome measure)
  • 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 ]
  • systolic blood pressure [ Time Frame: baseline, 3 months, 6 months, 12 months ] [ Designated as safety issue: No ]
  • diastolic blood pressure [ Time Frame: baseline, 3 months, 6 months, 12 months ] [ Designated as safety issue: No ]
  • waist circumference [ Time Frame: baseline, 3 months, 6 months, 12 months ] [ Designated as safety issue: No ]
  • 12-hour fasting lipid profile [ Time Frame: baseline, 3 months, 6 months, 12 months ] [ Designated as safety issue: No ]
  • 12-hour fasting glucose/hemoglobin A1C [ Time Frame: baseline, 3 months, 6 months, 12 months ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00885456 on ClinicalTrials.gov Archive Site
  • 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 ]
  • exercise capacity [ Time Frame: baseline, 3 months, 12 months ] [ Designated as safety issue: No ]
  • daily physical activity [ Time Frame: baseline, 3 months, 6 months, 12 months ] [ Designated as safety issue: No ]
  • walking endurance [ Time Frame: baseline, 3 months, 6 months, 12 months ] [ Designated as safety issue: No ]
  • cigarette smoking [ Time Frame: baseline, 3 months, 6 months, 12 months ] [ Designated as safety issue: No ]
  • medication adherence [ Time Frame: baseline, 3 months, 6 months, 12 months ] [ Designated as safety issue: No ]
  • cognition [ Time Frame: baseline, 12 months ] [ Designated as safety issue: No ]
  • depression [ Time Frame: baseline, 3 months, 6 months, 12 months ] [ Designated as safety issue: No ]
  • health-related quality of life [ Time Frame: baseline, 3 months, 6 months, 12 months ] [ Designated as safety issue: No ]
  • health-related goal attainment [ Time Frame: baseline, 3 months, 6 months, 12 months ] [ Designated as safety issue: No ]
  • direct health costs [ Time Frame: baseline, 3 months, 6 months, 12 months ] [ Designated as safety issue: No ]
  • secondary vascular events [ Time Frame: baseline, 3 months, 6 months, 12 months ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Program of Rehabilitative Exercise and Education to Avert Vascular Events After Non-disabling Stroke or Transient Ischemic Attack: A Multi-site RCT
Effectiveness of a Program of Rehabilitative Exercise and Education to Avert Vascular Events After Non-disabling Stroke: 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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Health Services Research
  • Transient Ischemic Attack
  • Non-disabling Stroke
  • 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
  • Behavioral: Usual Care
    Three or more out-patient visits to the neurovascular clinic for assessment, counseling and referral to appropriate health care professionals.
  • Experimental: PREVENT program
    12-week program of exercise and education to induce physiological and behavioral changes needed to reduce vascular risk factors.
    Intervention: Behavioral: PREVENT program
  • 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
    Intervention: Behavioral: Usual Care
MacKay-Lyons M, Gubitz G, Giacomantonio N, Wightman H, Marsters D, Thompson K, Blanchard C, Eskes G, Thornton M. 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. BMC Neurol. 2010 Dec 8;10:122. doi: 10.1186/1471-2377-10-122.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Enrolling by invitation
250
December 2015
December 2015   (final data collection date for primary outcome measure)

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.
Both
17 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT00885456
PREVENT Trial
Yes
Marilyn MacKay-Lyons, Capital District Health Authority, Canada
Marilyn MacKay-Lyons
  • Heart and Stroke Foundation of Canada
  • Canadian Institutes of Health Research (CIHR)
  • Canadian Stroke Network
Principal Investigator: Marilyn MacKay-Lyons, PhD Dalhousie University
Capital District Health Authority, Canada
October 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP