Cardiac Rehabilitation for TIA Patients (CR-TIA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00536562
Recruitment Status : Active, not recruiting
First Posted : September 28, 2007
Last Update Posted : August 28, 2017
Heart and Stroke Foundation of Ontario
Information provided by (Responsible Party):
Lawson Health Research Institute

Brief 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.

Condition or disease Intervention/treatment Phase
TIA (Transient Ischemic Attack) Behavioral: Comprehensive Cardiac Rehabilitation (CR) Phase 3

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Comprehensive Cardiac Rehabilitation Programming For Patients Following Transient Ischemic Attack
Study Start Date : September 2007
Actual Primary Completion Date : June 15, 2014
Estimated Study Completion Date : June 2018

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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)
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.
Other Name: Cardiac Rehabilitation

Primary Outcome Measures :
  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 Outcome Measures :
  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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   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:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00536562

Canada, Ontario
London Health Sciences Centre
London, Ontario, Canada, N6A 5A5
University of Ottawa Heart Institute
Ottawa, Ontario, Canada, K1Y 4W7
Sponsors and Collaborators
Lawson Health Research Institute
Heart and Stroke Foundation of Ontario
Principal Investigator: Neville G. Suskin, MBChB, MSc University of Western Ontario & London Health Sciences Centre

Responsible Party: Lawson Health Research Institute Identifier: NCT00536562     History of Changes
Other Study ID Numbers: R-07-251
First Posted: September 28, 2007    Key Record Dates
Last Update Posted: August 28, 2017
Last Verified: March 2017

Keywords provided by Lawson Health Research Institute:
Comprehensive Cardiac Rehabilitation
Randomized Controlled Trial
TIA (Transient Ischemic Attack)
Mild Non-Disabling Stroke
Vascular Protection

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