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Effects of Cardiac Rehabilitation for Individuals With Transient Ischemic Attack

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ClinicalTrials.gov Identifier: NCT00929994
Recruitment Status : Completed
First Posted : June 30, 2009
Last Update Posted : November 13, 2015
Sponsor:
Collaborator:
Heart and Stroke Foundation of Canada
Information provided by (Responsible Party):
Dina Brooks, Toronto Rehabilitation Institute

Study Description
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Brief Summary:

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 or disease Intervention/treatment
Transient Ischemic Attack Behavioral: Cardiac Rehabilitation

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)).

Study Design
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Study Type : Observational
Actual Enrollment : 21 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Effects of Cardiac Rehabilitation for Individuals With Transient Ischemic Attack
Study Start Date : March 2010
Actual Primary Completion Date : November 2014
Actual Study Completion Date : November 2014

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
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.


Outcome Measures
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Primary Outcome Measures :
  1. 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 :
  1. 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 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
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Responsible Party: Dina Brooks, Professor, Toronto Rehabilitation Institute
ClinicalTrials.gov Identifier: NCT00929994     History of Changes
Other Study ID Numbers: Brooks - 001
First Posted: June 30, 2009    Key Record Dates
Last Update Posted: November 13, 2015
Last Verified: November 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