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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Talk Test | Experimental | Virtual Cardiac Rehab + Exercise prescription based on the Talk test. |
|
| Cardiopulmonary Exercise Test | Experimental | Virtual Cardiac Rehab + Exercise prescription based on the CPET results. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Talk test prescription | Behavioral | Participants will be enrolled in the virtual cardiac rehab program and receive an exercise prescription based on the Talk test method. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Exercise capacity | will be measured by the Incremental Shuttle Walk Test. | from baseline to follow-up at week 12 |
| 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 |
| 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. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Andrew Pipe, MD | Ottawa Heart Institute Research Corporation | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Ottawa Heart Institute | Ottawa | Ontario | K1Y4W7 | Canada |
it is not yet known if there will be a plan to make IPD available.
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| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| CPET prescription | Behavioral | Participants will be enrolled in the virtual cardiac rehab program and receive an exercise prescription based on their CPET results completed at baseline |
|
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 |
| 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 |
| D001161 |
| Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |