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OpenTrials
Completed

NCT Number: NCT00929994

Effects of Cardiac Rehabilitation for Individuals With Transient Ischemic Attack

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.

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Key information

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Toronto Rehabilitation Institute - Rumsey Center

Toronto, Ontario, M4G 1R7, Canada

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cardiac rehabilitation

Behavioral

Individualized cardiac rehabilitation for 6 months, including health education sessions, as well as supervised exercise classes which include aerobic and resistance training.

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Toronto Rehabilitation Institute

Other

Collaborators

  • Heart and Stroke Foundation of Canada

Registry information

Important dates

Study start
2010
Primary completion
2014
Study completion
2014
First posted
Jun 30, 2009
Registry last updated
Apr 23, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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