Effects of Cardiac Rehabilitation for Individuals With Transient Ischemic Attack

April 20, 2019 updated by: Dina Brooks, Toronto Rehabilitation Institute

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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).

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
20

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M4G 1R7
        • Toronto Rehabilitation Institute - Rumsey Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 100 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

TIA

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
Baseline, 3 months, 6 months (Six Minute Walk Distance)
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.
Baseline (after the 3 month non-intervention period) and after 6 months of participation.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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).
Baseline and 3 months (non-intervention period), after 6 months of cardiac rehabilitation participation
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.
Baseline and 3 months (non-intervention period), after 6 months of cardiac rehabilitation participation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Toronto Rehabilitation Institute

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Heart and Stroke Foundation of Canada

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2010

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 1, 2014

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 1, 2014

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 29, 2009

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 29, 2009

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 30, 2009

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 23, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 20, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Brooks - 001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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