Domain-specific Aerobic Exercise Training in Coronary Artery Disease
ConditionCoronary Artery Disease
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorWestern University, Canada
About this trial
Exercise training in cardiac rehabilitation (rehab) is a key part of managing a patient with heart disease. It has been shown that cardiac patients who increase their aerobic ("cardio") fitness by exercise training live longer, have better quality of life, and stay out of hospitals more than patients who do not improve their aerobic fitness. The more a patient improves their aerobic fitness the greater the benefit. But it has been shown that more than half of patients do not improve their aerobic fitness even after participating in cardiac rehab. This may be related to how hard patients are asked to train (their training "intensity"). The way intensity is chosen in current programs is commonly based on a "one-size fits all" method that may not consider that different patients have different abilities. There are more personalized methods to determine training intensity that exist, but these have never been used in cardiac rehab. One method divides intensity into three zones (zone 1 = moderate intensity; zone 2 = heavy intensity; zone 3 = very high intensity) that are based on when an individuals' biological responses to exercise change. The purpose of this study is to see if this approach gives better results in terms of changes in aerobic fitness and if training in the different zones makes a difference. Three groups of patients will be asked to train for 3 months in one of the three intensity zones. Aerobic fitness before and after exercise training will be compared to see which intensity zone results in the largest change.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients with CAD who do not have any identified left ventricular dysfunction (i.e., left ventricular ejection fraction [LVEF] <50%) and who: were discharged from the hospital following admission for acute coronary syndrome (i.e., ST-elevation or non ST-elevation myocardial infarction, addressed with PCI or CABG, as documented by their attending physician; referred to St. Joseph's CRSP Program; completed a CPET at the St. Joseph's CRSP Program (as routine screening for cardiac rehabilitation) and have been cleared to exercise in a structured format (i.e., do not exhibit any contraindications to maximal exercise); without: respiratory or musculoskeletal issues that would prohibit them from cycling exercise.
Disqualifiers
Those who have: diagnosed heart failure, severe aortic stenosis, congenital coronary abnormality, 2-3° atrioventricular block, major arrhythmias such as atrial fibrillation (including paroxysmal), or are scheduled to undergo PCI or CABG surgery within 2 months following hospital discharge; are using insulin for diabetes; diagnosed with respiratory disease; or musculoskeletal issues that prohibit cycling exercise; and/or are unable to provide informed consent..
Trial design
Design model
Parallel
Treatments tested in this trial
Aerobic exercise training
Other interventionAerobic exercise training on a cycle ergometer
Treatment groups
105 Participants
are divided into 3 treatment groupsGroup A: Moderate-intensity continuous trainingExperimental treatment 1 intervention
Group B: Heavy-intensity continuous trainingExperimental treatment 1 intervention
Group C: High (severe)-intensity interval trainingExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Peak oxygen uptake
Post-training peak oxygen uptake achieved during a symptom-limited incremental exercise test to task failure
Time frame
baseline (week 0) and week 14Secondary outcomes
1
Positive responders
The frequency of "positive" responders to exercise training in each exercise intensity domain-specific training group will be quantified and compared. Responsiveness will be determined by previously established CAD-specific minimal reliable changes for peak oxygen uptake
Time frame
week 142
Gas exchange threshold
Post-training power output associated with the gas exchange threshold.
Time frame
baseline (week 0) and week 143
Respiratory compensation point
Post-training power output associated with the respiratory compensation point.
Time frame
baseline (week 0) and week 14Other outcomes
1
Cardiac output
Post-training submaximal and maximal cardiac output measured by open-circuit acetylene breathing.
Time frame
baseline (week 0) and week 142
Stroke volume
Post-training submaximal and maximal stroke volume.
Time frame
baseline (week 0) and week 143
Arterio-venous oxygen difference
Post-training submaximal and maximal arterio-venous oxygen difference.
Time frame
baseline (week 0) and week 144
Hemoglobin mass
Post-training hemoglobin mass measured by CO rebreathing.
Time frame
baseline (week 0) and week 14Sponsors and contacts
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Source ClinicalTrials.gov