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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
Results First Posted : April 23, 2019
Last Update Posted : April 23, 2019
Sponsor:
Collaborator:
Heart and Stroke Foundation of Canada
Information provided by (Responsible Party):
Dina Brooks, Toronto Rehabilitation Institute

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 depressive symptoms and cognition.


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 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).

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Study Type : Observational
Actual Enrollment : 20 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


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.
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.




Primary Outcome Measures :
  1. Functional Walk Test [ Time Frame: Baseline, 3 months, 6 months (Six Minute Walk Distance) ]
    6 minute walk test: the longest distance a person can walk for a duration of 6 minutes

  2. Cardiovascular Fitness (VO2peak) [ Time Frame: Baseline (after the 3 month non-intervention period) and after 6 months of participation. ]
    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.


Secondary Outcome Measures :
  1. Center for Epidemiologic Studies Depression Scale (CES-D). [ Time Frame: Baseline and 3 months (non-intervention period), after 6 months of cardiac rehabilitation participation ]
    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).

  2. Cognition [ Time Frame: Baseline and 3 months (non-intervention period), after 6 months of cardiac rehabilitation participation ]
    Montreal Cognitive Assessment. The MoCA score ranges from 0 to 30 points with a higher score indicating better cognitive function.



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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 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

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
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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
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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

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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
Results First Posted: April 23, 2019
Last Update Posted: April 23, 2019
Last Verified: April 2019

Keywords provided by Dina Brooks, Toronto Rehabilitation Institute:
cardiac rehab

Additional relevant MeSH terms:
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Ischemia
Ischemic Attack, Transient
Pathologic Processes
Brain Ischemia
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases