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

U

University of Ottawa Heart Institute

Status

Enrolling

Conditions

Coronary Artery Disease

Treatments

Behavioral: Talk test prescription
Behavioral: CPET prescription

Study type

Interventional

Funder types

Other

Identifiers

NCT05157932
20210525-01H

Details and patient eligibility

About

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.

Full description

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.

Enrollment

40 estimated patients

Sex

All

Ages

40+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Other

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

40 participants in 2 patient groups

Talk Test
Experimental group
Description:
Virtual Cardiac Rehab + Exercise prescription based on the Talk test.
Treatment:
Behavioral: Talk test prescription
Cardiopulmonary Exercise Test
Experimental group
Description:
Virtual Cardiac Rehab + Exercise prescription based on the CPET results.
Treatment:
Behavioral: CPET prescription

Trial contacts and locations

1

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Central trial contact

Jennifer Reed, PhD; Matheus Mistura

Data sourced from clinicaltrials.gov

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