Coronary Artery Disease Clinical Trial
— Talk-TestOfficial title:
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.
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. |
Country | Name | City | State |
---|---|---|---|
Canada | University of Ottawa Heart Institute | Ottawa | Ontario |
Lead Sponsor | Collaborator |
---|---|
Ottawa Heart Institute Research Corporation |
Canada,
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 |
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