Cardiac Rehabilitation for TIA Patients

TIA (Transient Ischemic Attack) Clinical Trial

— CR-TIA  

Official title:

Comprehensive Cardiac Rehabilitation Programming For Patients Following Transient Ischemic Attack

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00536562
• Other study ID #: R-07-251
• Status: Completed
• Phase: Phase 3
• Start date: September 2007
• Est. completion date: June 30, 2018

Study information

• Verified date: August 2019
• Source: Lawson Health Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 132
• Est. completion date: June 30, 2018
• Est. primary completion date: June 15, 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Ischemia
• Ischemic Attack, Transient
• TIA (Transient Ischemic Attack)

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
Canada	London Health Sciences Centre	London	Ontario
Canada	University of Ottawa Heart Institute	Ottawa	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
Lawson Health Research Institute	Heart and Stroke Foundation of Ontario

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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 include cerebrovascular and cardiovascular events, pre-post changes in physiological, anthropometric and behavioral vascular risk factors, neurocognitive measures, and quality of life.		6 months