Transient Ischemic Attack Clinical Trial
Official title:
Effects of Cardiac Rehabilitation for Individuals With Transient Ischemic Attack
NCT number | NCT00929994 |
Other study ID # | Brooks - 001 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | March 2010 |
Est. completion date | November 2014 |
Verified date | April 2019 |
Source | Toronto Rehabilitation Institute |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 20 |
Est. completion date | November 2014 |
Est. primary completion date | November 2014 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 100 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Canada | Toronto Rehabilitation Institute - Rumsey Center | Toronto | Ontario |
Lead Sponsor | Collaborator |
---|---|
Toronto Rehabilitation Institute | Heart and Stroke Foundation of Canada |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Functional Walk Test | 6 minute walk test: the longest distance a person can walk for a duration of 6 minutes | Baseline, 3 months, 6 months (Six Minute Walk Distance) | |
Primary | Cardiovascular Fitness (VO2peak) | 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. | Baseline (after the 3 month non-intervention period) and after 6 months of participation. | |
Secondary | Center for Epidemiologic Studies Depression Scale (CES-D). | 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). | Baseline and 3 months (non-intervention period), after 6 months of cardiac rehabilitation participation | |
Secondary | Cognition | Montreal Cognitive Assessment. The MoCA score ranges from 0 to 30 points with a higher score indicating better cognitive function. | Baseline and 3 months (non-intervention period), after 6 months of cardiac rehabilitation participation |
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