Cardiac Rehabilitation for TIA Patients

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.

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Key information

Conditions

TIA (Transient Ischemic Attack) Brain Diseases Brain Ischemia Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Ischemic Attack, Transient Nervous System Diseases Vascular Diseases

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

London Health Sciences Centre, London, Ontario, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Comprehensive Cardiac Rehabilitation (CR)

Behavioral

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 names: Cardiac Rehabilitation

Primary outcomes

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

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

Sponsors and collaborators

Lead sponsor

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

Other

Collaborators

Heart and Stroke Foundation of Ontario

Registry information

Official study title

Comprehensive Cardiac Rehabilitation Programming For Patients Following Transient Ischemic Attack

Acronym: CR-TIA

Important dates

Study start: 2007
Primary completion: 2014
Study completion: 2018
First posted: Sep 28, 2007
Registry last updated: Aug 13, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed