Comparing four treadmill exercise protocols in women and men with coronary artery disease

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

This project tests four treadmill exercise tests to see if women and men with coronary artery disease reach different peak oxygen use (VO2 peak).

Quick facts

• Study type: Observational
• Enrollment: 54 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Ottawa Heart Institute Research Corporation (Academic / other)
• Locations: 1 site (Ottawa, Ontario)
• Trial ID: NCT06179212 on ClinicalTrials.gov

What this trial studies

Researchers will have people with physician-diagnosed coronary artery disease complete four treadmill cardiopulmonary exercise tests — modified Balke, modified Bruce, modified Naughton, and the University of Ottawa Heart Institute Slow Ramp — to compare VO2 peak between females and males. Each protocol differs by stage duration and incremental changes in speed and incline, and tests are done to volitional exhaustion with breath-by-breath gas analysis. Eligible participants are adults at least eight weeks post cardiac event or procedure, able to walk on a treadmill and perform maximal exercise, and fluent in English or French. The observational study is conducted at a single center, the University of Ottawa Heart Institute.

Who should consider this trial

Good fit: Ideal candidates are adults with physician-diagnosed coronary artery disease who are at least eight weeks post cardiac event or procedure, can safely perform maximal treadmill exercise, and can read English or French.

Not a fit: Patients with ejection fraction below 45%, uncontrolled arrhythmias, peripheral artery disease, severe valvular disease (including severe aortic stenosis), cardiomyopathy, SCAD, COPD, inability to walk on a treadmill, or those within eight weeks of a cardiac event are unlikely to benefit or be eligible.

Why it matters

Potential benefit: If successful, results could help clinicians choose the treadmill protocol that most accurately measures peak oxygen use for women and men with CAD, improving individualized exercise testing and rehabilitation prescriptions.

How similar studies have performed: Standard treadmill cardiopulmonary exercise protocols are well-established, but direct head-to-head comparisons of these four protocols specifically to examine sex differences in VO2 peak among people with CAD are limited, making this a relatively novel comparison.

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).

Where this trial is running

Ottawa, Ontario

• University of Ottawa Heart Institute — Ottawa, Ontario, Canada (Recruiting)

Study contacts

• Principal investigator: Jennifer Reed, PhD — Ottawa Heart Institute Research Corporation
• Study coordinator: Jennifer Reed, PhD

Conditions Coronary Artery Disease