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Effects of Cardiac Rehabilitation for Individuals With Transient Ischemic Attack

This study is currently recruiting participants.
Verified November 2012 by Toronto Rehabilitation Institute
Sponsor:
Collaborator:
Heart and Stroke Foundation of Canada
Information provided by (Responsible Party):
Dina Brooks, Toronto Rehabilitation Institute
ClinicalTrials.gov Identifier:
NCT00929994
First received: June 29, 2009
Last updated: November 6, 2012
Last verified: November 2012
History of Changes
  Purpose

It is hypothesized that the addition of formal cardiac rehabilitation to standard care will result in long-term improvements in cardiovascular fitness and functional capacity in individuals who have suffered a transient ischemic attack (TIA) or minor stroke.

Furthermore, it is proposed that the addition of cardiac rehabilitation will influence stroke risk, physical activity participation, strength, and quality of life.


Condition Intervention
Transient Ischemic Attack
 Behavioral: Cardiac Rehabilitation

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Effects of Cardiac Rehabilitation for Individuals With Transient Ischemic Attack

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Toronto Rehabilitation Institute:

Primary Outcome Measures:
  • Primary outcomes include improvements in cardiovascular fitness, functional capacity, and physical activity levels in individuals with TIA. This will be measured using a cardiopulmonary exercise test and a 6 minute walk test. [ Time Frame: Baseline, 6 months, 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Secondary outcome measures are plasma lipid analysis, questionnaires pertaining to quality of life, physical activity and diet diaries, and results from the Montreal Cognitive Assessment and MRI analysis. [ Time Frame: Baseline, 6 months, 12 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 40
Study Start Date: March 2010
Estimated Study Completion Date: March 2013
Estimated Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Exercise
Participants in this group will participate in Cardiac Rehabilitation, carrying out an exercise program which will last 12 months and combine both resistance and aerobic training.
 Behavioral: Cardiac Rehabilitation
Individualized cardiac rehabilitation for 12 months, including health education sessions, as well as supervised exercise classes which include aerobic and resistance training.

Detailed Description:

A transient ischemic attack (TIA) is defined as an episode of neurological dysfunction caused by focal brain ischemia lasting less than 24 hours. Once an individual has suffered a TIA, preventative measures can be taken to target modifiable risk factors, one of which is physical inactivity. The current proposal focuses on the use of an established model of care (cardiac rehabilitation (CR)) and applies it to those who have suffered a TIA in order to maximize physical activity and minimize risk of future cardiovascular events. This will be a one-group pre/post design study. Participants will undergo measures at baseline, 6 and 12 months (cardiovascular fitness, 6 minute walk test, quality of life, diet, strength, physical activity, and Framingham Profile stroke risk (plasma lipids, blood pressure, medication use)).

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

TIA

Criteria

Inclusion Criteria:

  • Diagnosed with TIA
  • Three months post-TIA
  • Ability to understand the process and instructions for exercise training and provide informed consent

Exclusion Criteria:

  • Resting Blood Pressure greater than 160/100 despite medication
  • Other cardiovascular morbidity which would limit exercise tolerance (heart failure, abnormal BP responses or STsegment depression > 2 mm, symptomatic aortic stenosis, complex arrhythmias)
  • Current and extensive exercise participation
  • Hypertrophic Cardiomyopathy
  • Unstable Angina
  • Orthostatic BP decrease of > 20 mm Hg with symptoms
  • Other musculoskeletal impairments which would limit the participant's ability to walk sufficient durations
  • Pain or other co-morbidities (e.g., unclipped aneurysms, uncontrolled seizures etc.) which would preclude participation
  • Cognitive or behavioural issues that would limit participation in exercise testing and training
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00929994

Contacts
Contact: Dina Brooks, PhD 416-978-1739 Dina.Brooks@utoronto.ca

Locations
Canada, Ontario
Toronto Rehabilitation Institute - Rumsey Center Recruiting
Toronto, Ontario, Canada, M4G 1R7
Principal Investigator: Paul Oh, MD            
Sponsors and Collaborators
Toronto Rehabilitation Institute
Heart and Stroke Foundation of Canada
Investigators
Principal Investigator: Dina Brooks, PhD Toronto Rehabilitation Institute
Principal Investigator: William E McIllroy, PhD University of Waterloo
Principal Investigator: Paul Oh, MD Toronto Rehabilitation Institute
Principal Investigator: Sandra Black, MD Sunnybrook and Women's College Health Centre
  More Information

No publications provided

Responsible Party: Dina Brooks, Professor, Toronto Rehabilitation Institute
ClinicalTrials.gov Identifier: NCT00929994     History of Changes
Other Study ID Numbers: Brooks - 001
Study First Received: June 29, 2009
Last Updated: November 6, 2012
Health Authority: Canada: Ethics Review Committee

Keywords provided by Toronto Rehabilitation Institute:
cardiac rehab

Additional relevant MeSH terms:
Ischemic Attack, Transient
Ischemia
Brain Ischemia
Cerebrovascular Disorders
Brain Diseases
 Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on May 16, 2013