Effects of Cardiac Rehabilitation for Individuals With Transient Ischemic Attack

Transient Ischemic Attack Clinical Trial

Official title:

Effects of Cardiac Rehabilitation for Individuals With Transient Ischemic Attack

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00929994
• Other study ID #: Brooks - 001
• Status: Completed
• Start date: March 2010
• Est. completion date: November 2014

Study information

• Verified date: April 2019
• Source: Toronto Rehabilitation Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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).

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Ischemia
• Ischemic Attack, Transient
• Transient Ischemic Attack

Intervention

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.

Locations

Country	Name	City	State
Canada	Toronto Rehabilitation Institute - Rumsey Center	Toronto	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
Toronto Rehabilitation Institute	Heart and Stroke Foundation of Canada

Country where clinical trial is conducted

Canada, 

Outcome

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