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

Study Overview
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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.

Official Title
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An Evaluation of the Talk Test as an Effective and Safe Approach for Exercise Prescription for Home-Based Cardiac Rehabilitation: A Pilot RCT

Conditions
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Coronary Artery Disease

Intervention / Treatment
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* Behavioral: Talk test prescription
* Behavioral: CPET prescription


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Talk Test<br>Virtual Cardiac Rehab + Exercise prescription based on the Talk test. | Behavioral: Talk test prescription<br>* Participants will be enrolled in the virtual cardiac rehab program and receive an exercise prescription based on the Talk test method.<br>|
| Experimental: Cardiopulmonary Exercise Test<br>Virtual Cardiac Rehab + Exercise prescription based on the CPET results. | Behavioral: CPET prescription<br>* Participants will be enrolled in the virtual cardiac rehab program and receive an exercise prescription based on their CPET results completed at baseline<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Exercise capacity | will be measured by the Incremental Shuttle Walk Test. | from baseline to follow-up at week 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cardiovascular health indicators - Plasma glucose | will be measured by fasting plasma glucose (mmol/L) test | from baseline to follow-up at week 12 | 
| Cardiovascular health indicators - Plasma glucose average | will be measured using the glycated hemoglobin A1C (%) test | from baseline to follow-up at week 12 | 
| Cardiovascular health indicators - Lipid profile | will be measured using the triglycerides test | from baseline to follow-up at week 12 | 
| Cardiovascular health indicators - Cholesterol HDL | will be measured high-density lipoprotein cholesterol. | from baseline to follow-up at week 12 | 
| Cardiovascular health indicators - Cholesterol LDL | will be measured low-density lipoprotein cholesterol. | from baseline to follow-up at week 12 | 
| Cardiac Rehab safety | meticulously track all mild, moderate, and severe symptoms and adverse events throughout this study. Symptoms may include tightness in chest, leg tightness/pain, dizziness, lightheaded, foot cramping, and heart palpitations. | from baseline to follow-up at week 12 | 
| VO2peak | will be measured using a gold standard symptom-limited CPET on an electronically braked cycle ergometer (alternatively it will be administered on a treadmill or another aerobic equipment). Gas exchange (VO2 in mL/kg/min) and heart rate will be monitored continuously. The highest 20-s interval average of VO2 and HR will be considered the peak VO2 and HR values. | at baseline | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Coronary artery disease, Talk test, Cardiopulmonary Exercise test, Cardiac rehabilitation