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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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
• Email: jreed@ottawaheart.ca
• Phone: 613-696-7392

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.