An Evaluation of the Talk Test for Exercise Prescription for Home-Based Cardiac Rehabilitation

NCT ID: NCT05157932

Last Updated: 2024-01-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-02-08

Study Completion Date

2024-12-31

Brief Summary

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The objectives of this pilot RCT are to examine if the Talk Test is an effective and safe tool as compared with CPET for exercise prescription in patients who have undergone CABG or PCI and enrolled in a home-based CR program with virtual exercise training monitoring.

Detailed Description

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The Talk Test has been shown to be a valid, practical and inexpensive tool for guiding exercise training in patients with CAD. The general premise of the Talk Test is that exercising at or above the ventilatory threshold or lactate threshold does not allow comfortable, conversational speech and thus serves as a means of estimating the cut point between moderate and vigorous intensity exercise. The Talk Test can be used to produce exercise intensities (64 to 95% HR peak i.e. moderate-to-vigorous intensity exercise) within accepted Canadian Association of Cardiovascular Prevention and Rehabilitation (CACPR) guidelines for exercise training, to avoid exertional ischemia, and has been shown to be consistent across various modes of exercise (i.e. walking, jogging, cycling, elliptical trainer and stair stepper).

There is a critical need to evaluate the effectiveness and safety of using the Talk Test as the principal method of exercise prescription in patients with CAD who have undergone CABG or PCI when compared to standard care CPET. Such a trial has wide-scale appeal for CR programs across Canada and beyond. It will directly and positively impact patient care by reducing the need for in-person interactions for CPET, of paramount importance during COVID-19 outbreaks, between patients and CR staff, thus reducing COVID-19 infection risk and concerns of contracting the virus.

Conditions

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Coronary Artery Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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Talk Test

Virtual Cardiac Rehab + Exercise prescription based on the Talk test.

Group Type EXPERIMENTAL

Talk test prescription

Intervention Type BEHAVIORAL

Participants will be enrolled in the virtual cardiac rehab program and receive an exercise prescription based on the Talk test method.

Cardiopulmonary Exercise Test

Virtual Cardiac Rehab + Exercise prescription based on the CPET results.

Group Type EXPERIMENTAL

CPET prescription

Intervention Type BEHAVIORAL

Participants will be enrolled in the virtual cardiac rehab program and receive an exercise prescription based on their CPET results completed at baseline

Interventions

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Talk test prescription

Participants will be enrolled in the virtual cardiac rehab program and receive an exercise prescription based on the Talk test method.

Intervention Type BEHAVIORAL

CPET prescription

Participants will be enrolled in the virtual cardiac rehab program and receive an exercise prescription based on their CPET results completed at baseline

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* recently underwent PCI or CABG (at least 4 weeks but less than 12 weeks post-event or procedure);
* able to perform a CPET;
* at least 40 years of age;
* access to MyChart; and,
* access to email and the internet
* access to a cellphone with broadband internet (4G, LTE, 5G).

Exclusion Criteria

* currently participating in a virtual or on-site CR program;
* ventricular ejection fraction ≤45%;
* unstable angina or established diagnosis of chronic obstructive pulmonary disease, severe mitral or aortic stenosis, or hypertrophic obstructive cardiomyopathy;
* unable to return for 12-week follow-up visits.
Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ottawa Heart Institute Research Corporation

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Andrew Pipe, MD

Role: STUDY_CHAIR

Ottawa Heart Institute Research Corporation

Locations

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University of Ottawa Heart Institute

Ottawa, Ontario, Canada

Site Status RECRUITING

Countries

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Canada

Central Contacts

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Jennifer Reed, PhD

Role: CONTACT

6136967392

Matheus Mistura

Role: CONTACT

6136967000 ext. 15944

Facility Contacts

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Jennifer L Reed, PhD

Role: primary

6136967392 ext. 67392

Matheus Mistura, MSc, BSc

Role: backup

6136967000 ext. 15944

Other Identifiers

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20210525-01H

Identifier Type: -

Identifier Source: org_study_id

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