Exercise Testing Protocols for Females and Males With CAD

Coronary Artery Disease Clinical Trial

— PACED  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06179212
• Other study ID #: 20230327-01H
• Status: Not yet recruiting
• Start date: May 21, 2024
• Est. completion date: November 20, 2024

Study information

• Verified date: May 2024
• Source: Ottawa Heart Institute Research Corporation
• Contact: Jennifer Reed, PhD
• Phone: 613-696-7392
• Email: jreed[@]ottawaheart.ca
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 54
• Est. completion date: November 20, 2024
• Est. primary completion date: November 20, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Coronary Artery Disease

Intervention

Diagnostic Test:
• Exercise Tests
Patients will complete 4 different cardiopulmonary exercise tests in random order.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Ottawa Heart Institute Research Corporation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Oxygen Consumption (VO2)	V?O2 will be measured continuously throughout the treadmill CPET. Peak V?O2, defined as the highest V?O2 value that is achieved over a 20-s period during the last minute of the CPET. V?O2 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	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	Rating of perceived exertion (RPE)	Measured at the end of every stage using the validated Borg 6-20 rating of perceived exertion scale. This scale measures how physically exerted an individual feels. 6 is complete rest (i.e., no exertion, ex: sitting in a chair not moving and relaxed), 20 is perceived maximal exertion of effort. These values are perceived measures of effort and will increase as the exercise test progresses and gets harder for the patient.	Week 1 to week 4 (measured weekly, at every appointment)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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