Clinical trial NCT05157932: An Evaluation of the Talk Test for Exercise Prescription for Home-Based Cardiac Rehabilitation
Official title: An Evaluation of the Talk Test as an Effective and Safe Approach for Exercise Prescription for Home-Based Cardiac Rehabilitation: A Pilot RCT
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Coronary Artery Disease
Keywords: Coronary artery disease
Talk test
Cardiopulmonary Exercise test
Cardiac rehabilitation
Lead sponsor: Ottawa Heart Institute Research Corporation
Sponsor class: OTHER
First posted: 2021-12-15
Enrollment: 40
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: 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: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Exercise capacity
timeFrame: from baseline to follow-up at week 12
Secondary outcomes:
measure: Cardiovascular health indicators - Plasma glucose
timeFrame: from baseline to follow-up at week 12
measure: Cardiovascular health indicators - Plasma glucose average
timeFrame: from baseline to follow-up at week 12
measure: Cardiovascular health indicators - Lipid profile
timeFrame: from baseline to follow-up at week 12
measure: Cardiovascular health indicators - Cholesterol HDL
timeFrame: from baseline to follow-up at week 12
measure: Cardiovascular health indicators - Cholesterol LDL
timeFrame: from baseline to follow-up at week 12
measure: Cardiac Rehab safety
timeFrame: from baseline to follow-up at week 12
measure: VO2peak
timeFrame: at baseline
Other outcomes:
measure: Exercise prescription compliance
timeFrame: from baseline to follow-up at week 12
measure: Cardiometabolic health indicators - BMI
timeFrame: from baseline to follow-up at week 12
measure: Cardiometabolic health indicators - Body composition
timeFrame: from baseline to follow-up at week 12
measure: Cardiometabolic health indicators - Cardiometabolic Risk
timeFrame: from baseline to follow-up at week 12
measure: Cardiometabolic health indicators - Blood pressure
timeFrame: from baseline to follow-up at week 12
measure: Gender
timeFrame: from baseline to follow-up at week 12
Locations:
city: Ottawa
country: Canada
facility: University of Ottawa Heart Institute
state: Ontario
Study officials:
affiliation: Ottawa Heart Institute Research Corporation
name: Andrew Pipe, MD
role: STUDY_CHAIR
References: