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

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Coronary Artery Disease
• Intervention / Treatment: Behavioral: Talk test prescription; Behavioral: CPET prescription

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.

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Ottawa, Ontario, Canada, K1Y4W7
      • University of Ottawa Heart Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Talk Test; Virtual Cardiac Rehab + Exercise prescription based on the Talk test.	Behavioral: Talk test prescription; Participants will be enrolled in the virtual cardiac rehab program and receive an exercise prescription based on the Talk test method.
Experimental: Cardiopulmonary Exercise Test; Virtual Cardiac Rehab + Exercise prescription based on the CPET results.	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

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Exercise prescription compliance	Talk Test group: HR will be measured during exercise training using the Polar A370 device. Following each exercise session, participants will record on a Talk Test log if: (1) singing was possible, (2) comfortable conversation, but not singing was possible, or (3) comfortable conversation was not possible. These responses will be coded as "does not comply", "complies" and "exceeds". CPET group: HR will be measured during exercise training using the Polar A370 device. Where participants exercise below, within or above the prescribed HR ranges (64 to 95% HR peak), they will be coded as "does not comply", "complies" and "exceeds". All participants will wear Polar A370 devices during their exercise training sessions. Exercise HRs will be compared between the Talk Test and CPET groups.	from baseline to follow-up at week 12
Cardiometabolic health indicators - BMI	Height (cm) and body mass (kg) will be measured to compute body mass index (kg/m2)	from baseline to follow-up at week 12
Cardiometabolic health indicators - Body composition	Body composition will be measured using Fat mass (%) and fat-free mass (%), using bioelectrical impedance analysis.	from baseline to follow-up at week 12
Cardiometabolic health indicators - Cardiometabolic Risk	will be measured using waist circumference (cm) and will be measured using standardized procedures.	from baseline to follow-up at week 12
Cardiometabolic health indicators - Blood pressure	Resting Systolic (mmHg) and Diastolic (mmHg) blood pressure will be measured in a seated position after a 5-minute rest period on the right arm using an automated, BP monitor (BPTru) that measures 6 times (the first will be discarded and an average of the last 5 measurements will be used for statistical analyses) at 2-minute intervals.	from baseline to follow-up at week 12
Gender	gender and its effect will be assessed during cardiac rehabilitation	from baseline to follow-up at week 12

Collaborators and Investigators

• Sponsor: Ottawa Heart Institute Research Corporation
• Investigators: Study Chair: Andrew Pipe, MD, Ottawa Heart Institute Research Corporation

Study record dates

Study Major Dates

• Study Start (Actual): July 8, 2022
• Primary Completion (Estimated): July 31, 2026
• Study Completion (Estimated): July 31, 2026

Study Registration Dates

• First Submitted: October 8, 2021
• First Submitted That Met QC Criteria: December 1, 2021
• First Posted (Actual): December 15, 2021

Study Record Updates

• Last Update Posted (Actual): March 12, 2026
• Last Update Submitted That Met QC Criteria: March 11, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Coronary artery disease; Cardiac rehabilitation; Talk test; Cardiopulmonary Exercise test
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Heart Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Myocardial Ischemia; Coronary Artery Disease
• Other Study ID Numbers: 20210525-01H

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: it is not yet known if there will be a plan to make IPD available.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No