University of Ottawa Heart Institute
Ottawa, Ontario, K1Y4W7, Canada
NCT Number: NCT05157932
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.
This study is active but is not currently recruiting participants.
Notify Me40 year and older
All sexes
Interventional
Not applicable
Ottawa, Ontario, K1Y4W7, Canada
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Participants will be enrolled in the virtual cardiac rehab program and receive an exercise prescription based on the Talk test method.
Participants will be enrolled in the virtual cardiac rehab program and receive an exercise prescription based on their CPET results completed at baseline
Time frame: from baseline to follow-up at week 12
will be measured by the Incremental Shuttle Walk Test.
Time frame: from baseline to follow-up at week 12
will be measured by fasting plasma glucose (mmol/L) test
Time frame: from baseline to follow-up at week 12
will be measured using the glycated hemoglobin A1C (%) test
Time frame: from baseline to follow-up at week 12
will be measured using the triglycerides test
Time frame: from baseline to follow-up at week 12
will be measured high-density lipoprotein cholesterol.
Time frame: from baseline to follow-up at week 12
will be measured low-density lipoprotein cholesterol.
Time frame: from baseline to follow-up at week 12
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.
Time frame: at baseline
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.
Time frame: from baseline to follow-up at week 12
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.
Time frame: from baseline to follow-up at week 12
Height (cm) and body mass (kg) will be measured to compute body mass index (kg/m2)
Time frame: from baseline to follow-up at week 12
Body composition will be measured using Fat mass (%) and fat-free mass (%), using bioelectrical impedance analysis.
Time frame: from baseline to follow-up at week 12
will be measured using waist circumference (cm) and will be measured using standardized procedures.
Time frame: from baseline to follow-up at week 12
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.
Time frame: from baseline to follow-up at week 12
gender and its effect will be assessed during cardiac rehabilitation
Ottawa Heart Institute Research Corporation
Other
An Evaluation of the Talk Test as an Effective and Safe Approach for Exercise Prescription for Home-Based Cardiac Rehabilitation: A Pilot RCT
Acronym: Talk-Test
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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