Exercise Testing Protocols for Females and Males With CAD
ConditionCoronary Artery Disease
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorOttawa Heart Institute Research Corporation
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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;
Disqualifiers
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
Trial population
Adults older than 18 years of age and have been diagnosed with CAD.
Trial design
Design model
Case-only
Time perspective
Prospective
Treatments tested in this trial
Exercise Tests
Diagnostic testPatients will complete 4 different cardiopulmonary exercise tests in random order.
Treatment groups
54 Participants
are divided into 1 treatment groupGroup A: CPETs1 intervention
Trial outcomes
Primary outcomes
1
Oxygen Consumption (VO2)
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).
Time frame
Week 1 to week 4 (measured weekly, at every appointment)Secondary outcomes
1
Cardiometabolic health indicators - Blood pressure (BP)
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.
Time frame
Week 1 to week 4 (measured weekly, at every appointment)2
Cardiometabolic health indicators - Heart Rate (HR)
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.
Time frame
Week 1 to week 4 (measured weekly, at every appointment)3
Cardiometabolic health indicators - Body mass index
Height (cm) and body mass (kg) will be measured to compute body mass index (kg/m2).
Time frame
Week 1 to week 4 (measured weekly, at every appointment)4
Cardiometabolic health indicators - Fat mass
Fat mass (kg) and fat-free mass (kg) will be measured using bioelectrical impedance.
Time frame
Week 1 to week 4 (measured weekly, at every appointment)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov