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

Coronary Artery Disease Clinical Trial

— Talk-Test  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05157932
• Other study ID #: 20210525-01H
• Status: Recruiting
• Phase: N/A
• Start date: February 8, 2022
• Est. completion date: December 31, 2024

Study information

• Verified date: January 2024
• Source: Ottawa Heart Institute Research Corporation
• Contact: Jennifer Reed, PhD
• Phone: 6136967392
• Email: jreed[@]ottawaheart.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

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.
• 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

Locations

Country	Name	City	State
Canada	University of Ottawa Heart Institute	Ottawa	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Ottawa Heart Institute Research Corporation

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Other	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
Other	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
Other	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
Other	Gender	gender and its effect will be assessed during cardiac rehabilitation	from baseline to follow-up at week 12
Primary	Exercise capacity	will be measured by the Incremental Shuttle Walk Test.	from baseline to follow-up at week 12
Secondary	Cardiovascular health indicators - Plasma glucose	will be measured by fasting plasma glucose (mmol/L) test	from baseline to follow-up at week 12
Secondary	Cardiovascular health indicators - Plasma glucose average	will be measured using the glycated hemoglobin A1C (%) test	from baseline to follow-up at week 12
Secondary	Cardiovascular health indicators - Lipid profile	will be measured using the triglycerides test	from baseline to follow-up at week 12
Secondary	Cardiovascular health indicators - Cholesterol HDL	will be measured high-density lipoprotein cholesterol.	from baseline to follow-up at week 12
Secondary	Cardiovascular health indicators - Cholesterol LDL	will be measured low-density lipoprotein cholesterol.	from baseline to follow-up at week 12
Secondary	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
Secondary	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