Clinical trial NCT06179212: Exercise Testing Protocols for Females and Males With CAD
Official title: Comparing VO2 Peak Values of Exercise Testing Protocols for Females and Males With CAD
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Coronary Artery Disease
Lead sponsor: Ottawa Heart Institute Research Corporation
Sponsor class: OTHER
First posted: 2023-12-21
Enrollment: 54
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Adults older than 18 years of age and have been diagnosed with CAD.

Brief summary: 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, the investigators will find out:

1. 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,
2. if enjoyment affects the duration of the test, and
3. how different exercise test protocols will provide different results of maximal oxygen used by the participant's body during the exercise test.


Eligibility criteria: Inclusion Criteria:

1. 18 years and older;
2. previous CAD diagnosis by a physician;
3. can perform a CPET until volitional exhaustion;
4. are able to self-ambulate on a treadmill;
5. are at least 8 weeks post cardiovascular event or procedure (i.e., percutaneous coronary intervention (PCI), coronary artery bypass graft (CABG)); and,
6. are able to provide written informed consent.

Exclusion Criteria:

1. cannot speak, read, write, or understand English or French;
2. currently not enrolled in a CR program;
3. 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);
4. have heart failure with an ejection fraction \<45% (indication of possible cardiomyopathy);6
5. 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);
6. has an ICD;
7. is pregnant (sustained vigorous exercise in pregnant women may induce fetal bradycardia)
8. is unable to complete submaximal exercise testing (i.e., treadmill, due to musculoskeletal limitations).

Primary outcomes:
measure: Oxygen Consumption (VO2)
timeFrame: Week 1 to week 4 (measured weekly, at every appointment)
Secondary outcomes:
measure: Cardiometabolic health indicators - Blood pressure (BP)
timeFrame: Week 1 to week 4 (measured weekly, at every appointment)
measure: Cardiometabolic health indicators - Heart Rate (HR)
timeFrame: Week 1 to week 4 (measured weekly, at every appointment)
measure: Cardiometabolic health indicators - Body mass index
timeFrame: Week 1 to week 4 (measured weekly, at every appointment)
measure: Cardiometabolic health indicators - Fat mass
timeFrame: Week 1 to week 4 (measured weekly, at every appointment)
measure: Cardiometabolic health indicators - Waist circumference
timeFrame: Week 1 to week 4 (measured weekly, at every appointment)
measure: Cardiometabolic health indicators - Height
timeFrame: Week 1 to week 4 (measured weekly, at every appointment)
measure: Blood Lactate
timeFrame: Week 1 to week 4 (measured weekly, at every appointment)
measure: Rating of perceived exertion (RPE)
timeFrame: Week 1 to week 4 (measured weekly, at every appointment)
measure: Test duration
timeFrame: Week 1 to week 4 (measured weekly, at every appointment)
measure: Reason for test termination
timeFrame: Week 1 to week 4 (collected weekly, at every appointment)
measure: Physical activity enjoyment
timeFrame: Week 1 to week 4 (collected weekly, at every appointment)
measure: Most enjoyed test
timeFrame: Week 4 - collected at the patient's last appointment
Other outcomes:
Locations:
Study officials:
affiliation: Ottawa Heart Institute Research Corporation
name: Jennifer Reed, PhD
role: PRINCIPAL_INVESTIGATOR
References: