Cardiac Rehabilitation for TIA Patients

NCT00536562 | Completed Phase 3 DMC

• 1 other identifier: R-07-251
• Study Type: interventional
• Target: 132
• Locations: 1 country
• Sites: 2

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.

Conditions

TIA (Transient Ischemic Attack)

Keywords

Comprehensive Cardiac Rehabilitation; Randomized Controlled Trial; TIA (Transient Ischemic Attack); Mild Non-Disabling Stroke; Vascular Protection

Outcome Measures

Primary Outcomes (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.

  6 months

Secondary Outcomes (1)

• 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

Study Arms (2)

Usual Care

NO INTERVENTION

Usual Care as provided through the Stroke Prevention Clinic

Cardiac Rehabilitation

ACTIVE COMPARATOR

Usual Care plus Comprehensive Cardiac Rehabilitation Program

Behavioral: Comprehensive Cardiac Rehabilitation (CR)

Interventions

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.

Also known as: Cardiac Rehabilitation

Cardiac Rehabilitation

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's: lead
• Heart and Stroke Foundation of Ontario: collaborator

Study Sites (2)

London Health Sciences Centre

London, Ontario, N6A 5A5, Canada

Location

University of Ottawa Heart Institute

Ottawa, Ontario, K1Y 4W7, Canada

Location

MeSH Terms

Conditions

Ischemic Attack, Transient

Interventions

Cardiac Rehabilitation

Condition Hierarchy (Ancestors)

Brain Ischemia; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Neville G. Suskin, MBChB, MSc

  University of Western Ontario & London Health Sciences Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 27, 2007
• First Posted: September 28, 2007
• Study Start: September 1, 2007
• Primary Completion: June 15, 2014
• Study Completion: June 30, 2018
• Last Updated: August 13, 2019

Record last verified: 2019-08

Locations

CA (2)