|
Main
|
|
Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
12 November 2012 |
|
Main ID: |
NCT00929994 |
|
Date of registration:
|
29/06/2009 |
|
Primary sponsor: |
|
|
Public title:
|
Effects of Cardiac Rehabilitation for Individuals With Transient Ischemic Attack
|
|
Scientific title:
|
Effects of Cardiac Rehabilitation for Individuals With Transient Ischemic Attack |
|
Date of first enrolment:
|
March 2010 |
|
Target sample size:
|
40 |
|
Recruitment status: |
Recruiting |
|
URL:
|
http://clinicaltrials.gov/show/NCT00929994 |
|
Study type:
|
Observational |
|
Study design:
|
Observational Model: Cohort, Time Perspective: Prospective
|
|
|
Countries of recruitment
|
|
Canada
| | | | | | | |
|
Contacts
|
|
Name:
|
Dina Brooks, PhD |
|
Address:
|
|
|
Telephone:
|
416-978-1739 |
|
Email:
|
Dina.Brooks@utoronto.ca |
|
Affiliation:
|
|
|
|
Name:
|
Sandra Black, MD |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
Sunnybrook and Women's College Health Centre |
|
|
Name:
|
Dina Brooks, PhD |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
Toronto Rehabilitation Institute |
|
|
Name:
|
Paul Oh, MD |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
Toronto Rehabilitation Institute |
|
|
Name:
|
William E McIllroy, PhD |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
University of Waterloo |
| |
|
Key inclusion & exclusion 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
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
|
|
Health Condition(s) or Problem(s) studied
|
|
Transient Ischemic Attack
|
|
Intervention(s)
|
|
Behavioral: Cardiac Rehabilitation
|
|
Primary Outcome(s)
|
|
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(s)
|
|
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]
|
|
Secondary ID(s)
|
|
Brooks - 001
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|