Cardiac Rehabilitation for TIA Patients

NCT ID: NCT00536562

Last Updated: 2019-08-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

132 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-09-30

Study Completion Date

2018-06-30

Brief Summary

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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

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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.

Conditions

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TIA (Transient Ischemic Attack)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Usual Care

Usual Care as provided through the Stroke Prevention Clinic

Group Type NO_INTERVENTION

No interventions assigned to this group

Cardiac Rehabilitation

Usual Care plus Comprehensive Cardiac Rehabilitation Program

Group Type ACTIVE_COMPARATOR

Comprehensive Cardiac Rehabilitation (CR)

Intervention Type 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.

Interventions

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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.

Intervention Type BEHAVIORAL

Other Intervention Names

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Cardiac Rehabilitation

Eligibility Criteria

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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.
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Heart and Stroke Foundation of Ontario

OTHER

Sponsor Role collaborator

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

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Neville G. Suskin, MBChB, MSc

Role: PRINCIPAL_INVESTIGATOR

University of Western Ontario & London Health Sciences Centre

Locations

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London Health Sciences Centre

London, Ontario, Canada

Site Status

University of Ottawa Heart Institute

Ottawa, Ontario, Canada

Site Status

Countries

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Canada

Other Identifiers

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R-07-251

Identifier Type: -

Identifier Source: org_study_id

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