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Recruiting NCT06179212

Exercise Testing Protocols for Females and Males With CAD

— Observational Coronary Artery Disease

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Exercise Tests.
Who it may be relevant to
Registry conditions: Coronary Artery Disease. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Canada
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

Interventions

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

Primary outcome measures

  • Oxygen Consumption (VO2) [Time frame: Week 1 to week 4 (measured weekly, at every appointment)]
Secondary outcome measures (12)
  • Cardiometabolic health indicators - Blood pressure (BP) [Time frame: Week 1 to week 4 (measured weekly, at every appointment)]
  • Cardiometabolic health indicators - Heart Rate (HR) [Time frame: Week 1 to week 4 (measured weekly, at every appointment)]
  • Cardiometabolic health indicators - Body mass index [Time frame: Week 1 to week 4 (measured weekly, at every appointment)]
  • Cardiometabolic health indicators - Fat mass [Time frame: Week 1 to week 4 (measured weekly, at every appointment)]
  • Cardiometabolic health indicators - Waist circumference [Time frame: Week 1 to week 4 (measured weekly, at every appointment)]
  • Cardiometabolic health indicators - Height [Time frame: Week 1 to week 4 (measured weekly, at every appointment)]
  • Blood Lactate [Time frame: Week 1 to week 4 (measured weekly, at every appointment)]
  • Rating of perceived exertion (RPE) [Time frame: Week 1 to week 4 (measured weekly, at every appointment)]
  • Test duration [Time frame: Week 1 to week 4 (measured weekly, at every appointment)]
  • Reason for test termination [Time frame: Week 1 to week 4 (collected weekly, at every appointment)]
  • Physical activity enjoyment [Time frame: Week 1 to week 4 (collected weekly, at every appointment)]
  • Most enjoyed test [Time frame: Week 4 - collected at the patient's last appointment]

Eligibility criteria

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).

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Case-only

Study locations

Canada · 1 center
  • University of Ottawa Heart Institute — Ottawa

Identifiers

NCT: NCT06179212 · 20230327-01H

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗