NCT00885456

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
187

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Oct 2011

Longer than P75 for phase_2

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 21, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 22, 2009

Completed
2.5 years until next milestone

Study Start

First participant enrolled

October 30, 2011

Completed
5.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2017

Completed
Last Updated

March 23, 2018

Status Verified

March 1, 2018

Enrollment Period

5.7 years

First QC Date

April 21, 2009

Last Update Submit

March 21, 2018

Conditions

Transient Ischemic AttackNon-disabling Stroke

Keywords

strokesecondary preventionvascular riskbehavioral changeexerciselifestyle modification

Outcome Measures

Primary Outcomes (5)

  • systolic blood pressure (primary vascular risk factor being assessed)

    baseline, post-intervention, 6 months, 12 months

  • diastolic blood pressure

    baseline, post-intervention, 6 months, 12 months

  • waist circumference

    baseline, post-intervention, 6 months, 12 months

  • 12-hour fasting lipid profile

    baseline, post-intervention, 6 months, 12 months

  • 12-hour fasting glucose/hemoglobin A1C

    baseline, post-intervention, 6 months, 12 months

Secondary Outcomes (12)

  • exercise capacity

    baseline, post-intervention, 12 months

  • daily physical activity

    baseline, post-intervention, 6 months, 12 months

  • walking endurance

    baseline, post-intervention, 6 months, 12 months

  • cigarette smoking

    baseline, post-intervention, 6 months, 12 months

  • medication adherence

    baseline, post-intervention, 6 months, 12 months

  • +7 more secondary outcomes

Study Arms (2)

PREVENT program

EXPERIMENTAL

12-week program of exercise and education to induce physiological and behavioral changes needed to reduce vascular risk factors.

Behavioral: PREVENT program

Usual Care

ACTIVE COMPARATOR

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

Interventions

PREVENT programBEHAVIORAL

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

PREVENT program
Usual CareBEHAVIORAL

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

Usual Care

Eligibility Criteria

Age17 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Halifax Infirmary Site, QEII Health Sciences Centre

Halifax, Nova Scotia, B3H 3A7, Canada

Location

Annapolis Valley Regional Hospital

Kentville, Nova Scotia, B4N 5E3, Canada

Location

Related Publications (2)

  • MacKay-Lyons M, Gubitz G, Phillips S, Giacomantonio N, Firth W, Thompson K, Theriault C, Wightman H, Slipp S, Marsters D, Eskes G, Peacock F, Blanchard C, Dewolfe J. Program of Rehabilitative Exercise and Education to Avert Vascular Events After Non-Disabling Stroke or Transient Ischemic Attack (PREVENT Trial): A Randomized Controlled Trial. Neurorehabil Neural Repair. 2022 Feb;36(2):119-130. doi: 10.1177/15459683211060345. Epub 2021 Nov 17.

    PMID: 34788569DERIVED

  • 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.

    PMID: 21143864DERIVED

MeSH Terms

Conditions

Ischemic Attack, TransientStrokeMotor Activity

Condition Hierarchy (Ancestors)

Brain IschemiaCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesBehavior

Study Officials

  • Marilyn MacKay-Lyons, PhD

    Dalhousie University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Affiliated Scientist

Study Record Dates

First Submitted

April 21, 2009

First Posted

April 22, 2009

Study Start

October 30, 2011

Primary Completion

June 30, 2017

Study Completion

June 30, 2017

Last Updated

March 23, 2018

Record last verified: 2018-03

Locations

CA(2)