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CompletedNCT00536562CR-TIAUpdated Aug 13, 2019

Cardiac Rehabilitation for TIA Patients

A Phase 3 interventional study of Comprehensive Cardiac Rehabilitation (CR) in TIA (Transient Ischemic Attack), sponsored by London Health Sciences Centre Research Institute and Lawson Research Institute of St. Joseph's. Completed at 2 sites in Canada. Open to participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2019-08-13.

Sponsored by London Health Sciences Centre Research Institute and Lawson Research Institute of St. Joseph's · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
132
Allocation
Randomized
Ages
20 Years and older
Sex
All
01

Study summary

The purpose of this study is to determine, in patients following a TIA, whether a 6-month case-managed exercise based multi-factorial cardiac rehabilitation program (CR), similar to those used in patients following a heart attack, can significantly improve exercise capacity, reduce cholesterol, reduce depression, and improve thinking ability.

Read the detailed description

Similar risk factors predispose patients to both cardiovascular and cerebrovascular events. Two hundred consecutive patients from Stroke Prevention Clinics (SPC) at London Health Sciences Centre and the Ottawa Hospital (100 patients from each site) who have sustained a Transient Ischemic Attack (TIA) or mild non-disabling stroke will participate in a randomized controlled trial in which they will either receive Usual Care (UC) as delivered by the SPC, or enter the existing multi-disciplinary 6-month comprehensive cardiac rehabilitation (CR) intervention at LHSC and Ottawa in addition to receiving UC. This study seeks to determine the benefits of providing a CR program to TIA/mild non-disabling stroke patients.

02

Conditions studied

  • TIA (Transient Ischemic Attack)

Keywords

  • Comprehensive Cardiac Rehabilitation
  • Randomized Controlled Trial
  • TIA (Transient Ischemic Attack)
  • Mild Non-Disabling Stroke
  • Vascular Protection
03

In context

Ischemic Attack, Transient

293 studies on the registry are indexed under Ischemic Attack, Transient; 64 are open to participants now.

This study's enrollment of 132 is below the median of 206 across 164 interventional studies indexed under Ischemic Attack, Transient.

Browse Ischemic Attack, Transient studies →

Lead sponsor

London Health Sciences Centre Research Institute and Lawson Research Institute of St. Joseph's is the lead sponsor of 352 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Documented TIA or mild non-disabling stroke within the previous 3 months.
  • At least one of the following vascular risk factors: hypertension, ischemic heart disease, diabetes mellitus, dyslipidemia or cigarette smoking

Exclusion criteria

Exclusion Criteria:

  • Inability to speak or understand English or provide informed consent.
  • Severe aphasia that renders communication difficult or impossible.
  • Modified Rankin Scale score of greater than or equal to 3.
  • Mini-Mental Status Examination score of less than or equal to 20.
  • Evidence of intracranial hemorrhage confirmed by CT scan or MRI study.
  • Anticipated or recent (\<30 days) carotid endarterectomy, angioplasty and/or stenting.
  • Resides >1 hour travel time from London or Ottawa.
  • Prior participation in a CCR program.
  • Inability to perform expected exercise training of CCR program.
  • Evidence of cardioembolic source for TIA/stroke such as atrial fibrillation, valvular disease, septal defect or left ventricular wall motion abnormality.
  • Participation in another clinical trial that could interfere with the intervention or outcomes of the current study.
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
132 participants (actual)

Study arms

  • No intervention
    Usual Care

    Usual Care as provided through the Stroke Prevention Clinic

  • Active comparator
    Cardiac Rehabilitation

    Usual Care plus Comprehensive Cardiac Rehabilitation Program

    Behavioral: Comprehensive Cardiac Rehabilitation (CR)

Interventions

  • BehavioralComprehensive Cardiac Rehabilitation (CR)

    6-month Comprehensive Cardiac Rehabilitation program consisting of: 1) initial medical assessment by case manager and physician to determine CR strategies; 2) entry exercise stress test; 3) multi-disciplinary assessment and intervention to achieve risk factor targets in nutrition \& psychological services as needed; 4) twice per week supervised exercise training and twice per week home-based exercise following an individualized, progressive prescription; 5) Exit assessment at 6 months.

    Also known as: Cardiac Rehabilitation

06

What researchers measure

Primary outcomes

  1. To determine compared to usual care, whether a 6-month CR strategy results in significant improvements of functional capacity, lipid profile, depression symptoms and cognition.

    Time frame: 6 months

Secondary outcomes

  1. Outcomes include cerebrovascular and cardiovascular events, pre-post changes in physiological, anthropometric and behavioral vascular risk factors, neurocognitive measures, and quality of life.

    Time frame: 6 months

07

Study locations

2 sites
  • London Health Sciences Centre
    London, Ontario N6A 5A5, Canada
  • University of Ottawa Heart Institute
    Ottawa, Ontario K1Y 4W7, Canada
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 13, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00536562
Lead sponsor
London Health Sciences Centre Research Institute and Lawson Research Institute of St. Joseph's
Collaborators
Heart and Stroke Foundation of Ontario
Responsible party
Sponsor
First posted
Sep 28, 2007
Start date
Sep 2007
Primary completion
Jun 15, 2014
Completion
Jun 30, 2018
Last update
Aug 13, 2019

Study contacts

Neville G. Suskin, MBChB, MSc
principal investigator · University of Western Ontario & London Health Sciences Centre

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2019. You cannot join it, but the record below documents what was studied.

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