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NCT Number: NCT06179212

Exercise Testing Protocols for Females and Males With CAD

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.

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Key information

Conditions

Coronary Artery Disease Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Coronary Disease Heart Diseases Myocardial Ischemia Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Exercise Tests

Diagnostic Test

Patients will complete 4 different cardiopulmonary exercise tests in random order.

Primary outcomes

  1. Oxygen Consumption (VO2)

    Time frame: Week 1 to week 4 (measured weekly, at every appointment)

    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).

Secondary outcomes

  1. Cardiometabolic health indicators - Blood pressure (BP)

    Time frame: Week 1 to week 4 (measured weekly, at every appointment)

    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.

  2. Cardiometabolic health indicators - Heart Rate (HR)

    Time frame: Week 1 to week 4 (measured weekly, at every appointment)

    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.

  3. Cardiometabolic health indicators - Body mass index

    Time frame: Week 1 to week 4 (measured weekly, at every appointment)

    Height (cm) and body mass (kg) will be measured to compute body mass index (kg/m2).

  4. Cardiometabolic health indicators - Fat mass

    Time frame: Week 1 to week 4 (measured weekly, at every appointment)

    Fat mass (kg) and fat-free mass (kg) will be measured using bioelectrical impedance.

  5. Cardiometabolic health indicators - Waist circumference

    Time frame: Week 1 to week 4 (measured weekly, at every appointment)

    Waist circumference will be measured using standardized procedures (2 repeated measures using a tape; in centimeters).

  6. Cardiometabolic health indicators - Height

    Time frame: Week 1 to week 4 (measured weekly, at every appointment)

    Height will be measured using standardized procedures (2 repeated measures using a tape; in centimeters).

  7. Blood Lactate

    Time frame: Week 1 to week 4 (measured weekly, at every appointment)

    Blood lactate (mmol/L) will be measured in the last 30s of every test stage throughout the test using a blood lactate analyzer.

  8. Rating of perceived exertion (RPE)

    Time frame: Week 1 to week 4 (measured weekly, at every appointment)

    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.

  9. Test duration

    Time frame: Week 1 to week 4 (measured weekly, at every appointment)

    Measured using portable metabolic system that is connected to a computer. The duration of the test will be recorded.

  10. Reason for test termination

    Time frame: Week 1 to week 4 (collected weekly, at every appointment)

    Reason for test termination will be collected subjectively by asking the patient (i.e., fatigue, muscular limitation, etc.)

  11. Physical activity enjoyment

    Time frame: Week 1 to week 4 (collected weekly, at every appointment)

    This is a subjective questionnaire that measures the extent to which the patient enjoyed participating in the test.

  12. Most enjoyed test

    Time frame: Week 4 - collected at the patient's last appointment

    Using a feedback questionnaire, the test that was most frequently ranked the most enjoyed by patients will be measured

Study contacts

Contact information is provided by the study sponsor or research team.

Jennifer Reed, PhD

CONTACT

[email protected]

613-696-7392

Matheus Mistura, MSc

CONTACT

[email protected]

6136967000 ext. 15944

Sponsors and collaborators

Lead sponsor

Ottawa Heart Institute Research Corporation

Other

Registry information

Official study title

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

Acronym: PACED

Important dates

Study start
2024
Primary completion
2028
Study completion
2030
First posted
Dec 21, 2023
Registry last updated
Mar 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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