Cardiac Rehabilitation for TIA Patients

Phase 3

Completed

• Conditions: TIA (Transient Ischemic Attack)
• Interventions: Behavioral: Comprehensive Cardiac Rehabilitation (CR)

• Registration Number: NCT00536562
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2007-09
• Study First Submitted: 2007-09-27
• Study First Submitted QC: 2007-09-27
• Study First Posted: 2007-09-28
• Primary Completion: 2014-06-15
• Study Completion: 2018-06-30
• Status Verified: 2019-08
• Last Update Submitted: 2019-08-12
• Last Update Posted: 2019-08-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 132

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cardiac Rehabilitation	Comprehensive Cardiac Rehabilitation (CR)	Usual Care plus Comprehensive Cardiac Rehabilitation Program

Primary Outcome Measures

Name	Time	Method
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.	6 months

Secondary Outcome Measures

Name	Time	Method
Outcomes include cerebrovascular and cardiovascular events, pre-post changes in physiological, anthropometric and behavioral vascular risk factors, neurocognitive measures, and quality of life.	6 months

Trial Locations

Locations (2)

London Health Sciences Centre; 🇨🇦 London, Ontario, Canada

University of Ottawa Heart Institute; 🇨🇦 Ottawa, Ontario, Canada