Overview

This trial is active, not recruiting.

Condition tia (transient ischemic attack)
Treatment comprehensive cardiac rehabilitation (cr)
Phase phase 3
Sponsor Lawson Health Research Institute
Collaborator Heart and Stroke Foundation of Ontario
Start date September 2007
End date June 2014
Trial size 200 participants
Trial identifier NCT00536562, R-07-251

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking single blind (outcomes assessor)
Primary purpose treatment
Arm
(No Intervention)
Usual Care as provided through the Stroke Prevention Clinic
(Active Comparator)
Usual Care plus Comprehensive Cardiac Rehabilitation Program
comprehensive cardiac rehabilitation (cr) Cardiac Rehabilitation
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.

Primary Outcomes

Measure
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

Measure
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

Eligibility Criteria

Male or female participants at least 20 years old.

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.

Additional Information

Official title Comprehensive Cardiac Rehabilitation Programming For Patients Following Transient Ischemic Attack
Principal investigator Neville G. Suskin, MBChB, MSc
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.
Trial information was received from ClinicalTrials.gov and was last updated in March 2014.
Information provided to ClinicalTrials.gov by Lawson Health Research Institute.