Effects of Cardiac Rehabilitation for Individuals With Transient Ischemic Attack

This study has been completed.

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 11, 2015

Last verified: November 2015

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:

MedlinePlus related topics: Cardiac Rehabilitation Exercise and Physical Fitness Rehabilitation Transient Ischemic Attack

U.S. FDA Resources

Further study details as provided by Dina Brooks, 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 ]

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 ]


Enrollment:	21
Study Start Date:	March 2010
Study Completion Date:	November 2014
Primary Completion Date:	November 2014 (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 6 months and combine both resistance and aerobic training.	Behavioral: Cardiac Rehabilitation Individualized cardiac rehabilitation for 6 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 to 100 Years (Adult, Senior)
Sexes Eligible for Study:	All
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00929994

Locations


Canada, Ontario
Toronto Rehabilitation Institute - Rumsey Center
Toronto, Ontario, Canada, M4G 1R7

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


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 11, 2015

Keywords provided by Dina Brooks, Toronto Rehabilitation Institute:


cardiac rehab

Additional relevant MeSH terms:


Ischemia Ischemic Attack, Transient Pathologic Processes Brain Ischemia Cerebrovascular Disorders	Brain Diseases Central Nervous System Diseases Nervous System Diseases Vascular Diseases Cardiovascular Diseases

ClinicalTrials.gov processed this record on August 23, 2017

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