- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00929994
Effects of Cardiac Rehabilitation for Individuals With Transient Ischemic Attack
April 20, 2019 updated by: Dina Brooks, Toronto Rehabilitation Institute
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 depressive symptoms and cognition.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 with a 3 month non-intervention period.
Participants will undergo measures at baseline and 3 months (non intervention period) then after 6 months of cardiac rehabilitation (cardiovascular fitness, 6 minute walk test, cognition, and depressive symptoms).
Study Type
Observational
Enrollment (Actual)
20
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Ontario
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Toronto, Ontario, Canada, M4G 1R7
- Toronto Rehabilitation Institute - Rumsey Center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 100 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
TIA
Description
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 participants 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Exercise
Following a 3 month non intervention period, participants will participate in Cardiac Rehabilitation, carrying out an exercise program which will last 6 months and combine both resistance and aerobic training.
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Individualized cardiac rehabilitation for 6 months, including health education sessions, as well as supervised exercise classes which include aerobic and resistance training.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Functional Walk Test
Time Frame: Baseline, 3 months, 6 months (Six Minute Walk Distance)
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6 minute walk test: the longest distance a person can walk for a duration of 6 minutes
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Baseline, 3 months, 6 months (Six Minute Walk Distance)
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Cardiovascular Fitness (VO2peak)
Time Frame: Baseline (after the 3 month non-intervention period) and after 6 months of participation.
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To measure cardiovascular fitness, a stress test on either an upright cycle ergometer (Ergoselect 200P, Germany), or a treadmill (same modality pre- and post-training) was performed depending on patient balance and comfort.
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Baseline (after the 3 month non-intervention period) and after 6 months of participation.
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Center for Epidemiologic Studies Depression Scale (CES-D).
Time Frame: Baseline and 3 months (non-intervention period), after 6 months of cardiac rehabilitation participation
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Depressive symptoms using the validated Center for Epidemiologic Studies Depression Scale (CES-D).
This is a score from a 20 item questionnaire with minimum value of 0 and maximum value of 60 with higher numbers indicated greater depressive symptoms (worse).
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Baseline and 3 months (non-intervention period), after 6 months of cardiac rehabilitation participation
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Cognition
Time Frame: Baseline and 3 months (non-intervention period), after 6 months of cardiac rehabilitation participation
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Montreal Cognitive Assessment.
The MoCA score ranges from 0 to 30 points with a higher score indicating better cognitive function.
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Baseline and 3 months (non-intervention period), after 6 months of cardiac rehabilitation participation
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
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
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2010
Primary Completion (Actual)
November 1, 2014
Study Completion (Actual)
November 1, 2014
Study Registration Dates
First Submitted
June 29, 2009
First Submitted That Met QC Criteria
June 29, 2009
First Posted (Estimate)
June 30, 2009
Study Record Updates
Last Update Posted (Actual)
April 23, 2019
Last Update Submitted That Met QC Criteria
April 20, 2019
Last Verified
April 1, 2019
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Brooks - 001
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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