Effects of Cardiac Rehabilitation for Individuals With Transient Ischemic Attack
This study has been completed.
Sponsor:
Toronto Rehabilitation Institute
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
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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:
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 ]
| 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) |
| 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
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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
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 |
| Health Authority: | Canada: Ethics Review Committee |
Keywords provided by 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 September 30, 2016