Coronary Artery Disease
Conditions
Keywords
Coronary artery disease, Talk test, Cardiopulmonary Exercise test, Cardiac rehabilitation
Brief 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.
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.
Interventions
BEHAVIORALTalk test prescription
Participants will be enrolled in the virtual cardiac rehab program and receive an exercise prescription based on the Talk test method.
BEHAVIORALCPET prescription
Participants will be enrolled in the virtual cardiac rehab program and receive an exercise prescription based on their CPET results completed at baseline
Sponsors
Ottawa Heart Institute Research Corporation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Exercise capacity | from baseline to follow-up at week 12 | will be measured by the Incremental Shuttle Walk Test. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cardiovascular health indicators - Plasma glucose | from baseline to follow-up at week 12 | will be measured by fasting plasma glucose (mmol/L) test |
| Cardiovascular health indicators - Plasma glucose average | from baseline to follow-up at week 12 | will be measured using the glycated hemoglobin A1C (%) test |
| Cardiovascular health indicators - Lipid profile | from baseline to follow-up at week 12 | will be measured using the triglycerides test |
| Cardiovascular health indicators - Cholesterol HDL | from baseline to follow-up at week 12 | will be measured high-density lipoprotein cholesterol. |
| Cardiovascular health indicators - Cholesterol LDL | from baseline to follow-up at week 12 | will be measured low-density lipoprotein cholesterol. |
| Cardiac Rehab safety | 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. |
| VO2peak | 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. |
Countries
Canada
Contacts
STUDY_CHAIRAndrew Pipe, MD
Ottawa Heart Institute Research Corporation
Outcome results
None listed