Exercise Testing Protocols for Females and Males With CAD

Study Overview
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Brief Summary
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The aim of this study is to determine if the test that allows males to achieve a higher VO2 (a measure of oxygen use during exercise) is different for females. The purpose of this study is to test 4 different exercise testing protocols to compare measured oxygen consumption in females and males with CAD (disease caused by the buildup of plaque in the artery walls which can lead to insufficient amounts of blood, nutrients and oxygen being supplied to the heart). The 4 exercise tests that will be completed on the treadmill are the modified Balke, modified Bruce, modified Naughton and University of Ottawa Heart Institute Slow Ramp protocols. Each test has a different stage duration (the amount of time that the test remains at a pre-determined speed and incline), and incremental increase in speed and incline. The main purpose of this study is to compare VO2 peak (the maximal amount of oxygen utilized during the exercise test) of females and males with CAD in 4 different exercise protocols. For example, we will find out: which exercise protocol is more likely to achieve a higher peak V̇O2 in females and which protocol is more likely to achieve a higher peak V̇O2 in males, if enjoyment affects the duration of the test, and how different exercise test protocols will provide different results of maximal oxygen used by your body during the exercise test.

Official Title
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Comparing VO2 Peak Values of Exercise Testing Protocols for Females and Males With CAD

Conditions
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Coronary Artery Disease

Intervention / Treatment
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* Diagnostic Test: Exercise Tests


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18 years and older; previous CAD diagnosis by a physician; can perform a CPET until volitional exhaustion; are able to self-ambulate on a treadmill; are at least 8 weeks post cardiovascular event or procedure (i.e., percutaneous coronary intervention (PCI), coronary artery bypass graft (CABG)); and, are able to provide written informed consent. Exclusion Criteria: cannot speak, read, write, or understand English or French; currently not enrolled in a CR program; have recently changed (or planning to change) PA levels within the previous 4 weeks (as this may impact the ability to compare outcomes between exercise testing protocols); have heart failure with an ejection fraction <45% (indication of possible cardiomyopathy);6 have an arrythmia (relative contraindication for exercise testing),6 peripheral artery disease, valvular disease, severe aortic stenosis, cardiomyopathy, SCAD and/or COPD (contraindications for maximal exercise testing); has an ICD; is pregnant (sustained vigorous exercise in pregnant women may induce fetal bradycardia) is unable to complete submaximal exercise testing (i.e., treadmill, due to musculoskeletal limitations).

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| CPETs<br>Patients will perform all 4 maximal cardiopulmonary exercise tests in randomized order. The protocols they will perform are: Modified Bruce, modified Naughton, modified Balke and the UOHI Slow Ramp. | Diagnostic Test: Exercise Tests<br>* Patients will complete 4 different cardiopulmonary exercise tests in random order.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Oxygen Consumption (VO2) | V̇O2 will be measured continuously throughout the treadmill CPET. Peak V̇O2, defined as the highest V̇O2 value that is achieved over a 20-s period during the last minute of the CPET. V̇O2 will be measured throughout each test by a metabolic system (Parvo Medics TrueOne 2400). | Week 1 to week 4 (measured weekly, at every appointment) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cardiometabolic health indicators - Blood pressure (BP) | Resting BP (mmHg) will be measured from a seated position using an automated BP monitor. BP will be measured manually using a BP cuff every 2 stages throughout the CPET using an automated BP monitor. Recovery BP will be measured after the completion of the test from a seated position using the automated BP monitor. | Week 1 to week 4 (measured weekly, at every appointment) | 
| Cardiometabolic health indicators - Heart Rate (HR) | Heart rate will be measured from a seated position using an automated BP monitor. HR will be measured continuously throughout the CPET using a 4-lead electrocardiogram connected to a metabolic system. Recovery HR will be measured after the completion of the test from a seated position using the automated BP monitor. | Week 1 to week 4 (measured weekly, at every appointment) | 
| Cardiometabolic health indicators - Body mass index | Height (cm) and body mass (kg) will be measured to compute body mass index (kg/m2). | Week 1 to week 4 (measured weekly, at every appointment) | 
| Cardiometabolic health indicators - Fat mass | Fat mass (kg) and fat-free mass (kg) will be measured using bioelectrical impedance. | Week 1 to week 4 (measured weekly, at every appointment) | 
| Cardiometabolic health indicators - Waist circumference | Waist circumference will be measured using standardized procedures (2 repeated measures using a tape; in centimeters). | Week 1 to week 4 (measured weekly, at every appointment) | 
| Cardiometabolic health indicators - Height | Height will be measured using standardized procedures (2 repeated measures using a tape; in centimeters). | Week 1 to week 4 (measured weekly, at every appointment) | 
| Blood Lactate | Blood lactate (mmol/L) will be measured in the last 30s of every test stage throughout the test using a blood lactate analyzer. | Week 1 to week 4 (measured weekly, at every appointment) | 
| Rating of perceived exertion | Measured at the end of every stage using the validated Borg 6-20 RPE scale. This scale measures how physically exerted an individual feels | Week 1 to week 4 (measured weekly, at every appointment) | 
| Test duration | Measured using portable metabolic system that is connected to a computer. The duration of the test will be recorded. | Week 1 to week 4 (measured weekly, at every appointment) | 
| Reason for test termination | Reason for test termination will be collected subjectively by asking the patient (i.e., fatigue, muscular limitation, etc.) | Week 1 to week 4 (collected weekly, at every appointment) | 
| Physical activity enjoyment | This is a subjective questionnaire that measures the extent to which the patient enjoyed participating in the test. | Week 1 to week 4 (collected weekly, at every appointment) | 
| Most enjoyed test | Using a feedback questionnaire, the test that was most frequently ranked the most enjoyed by patients will be measured | Week 4 - collected at the patient's last appointment |