Exercise Testing Protocols for Females and Males With CAD

NCT ID: NCT06179212

Last Updated: 2024-05-07

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 54 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-05-21
• Study Completion Date: 2024-11-20

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.

Conditions

Coronary Artery Disease

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Study Groups

CPETs

Patients will perform all 4 maximal cardiopulmonary exercise tests in randomized order. The protocols they will perform are: Modified Bruce, modified Naughton, modified Balke and the UOHI Slow Ramp.

Exercise Tests

Intervention Type: DIAGNOSTIC_TEST

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

Interventions

Exercise Tests

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

Intervention Type: DIAGNOSTIC_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).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ottawa Heart Institute Research Corporation

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jennifer Reed, PhD

Role: PRINCIPAL_INVESTIGATOR

Ottawa Heart Institute Research Corporation

Central Contacts

Jennifer Reed, PhD

Role: CONTACT

jreed@ottawaheart.ca

613-696-7392

Matheus Mistura, MSc

Role: CONTACT

mmistura@ottawaheart.ca

6136967000 ext. 15944

Other Identifiers

20230327-01H

Identifier Type: -

Identifier Source: org_study_id