An interventional study of Aerobic exercise training in Coronary Artery Disease, sponsored by Western University, Canada. Recruiting at 1 site in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-27.
Sponsored by Western University, Canada · Not applicable, Interventional, and Prevention
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.
105 patients with coronary artery disease will randomized at a ratio of 1:1:1 to three months of personalized domain-based and work-matched training in the: 1) moderate-; 2) heavy-; and 3) severe-intensity domains. Age and sex-balance between groups will be achieved by stratified-block randomization
After randomization, the protocol is split in two. The "Testing" portion includes physiological, health, and anthropometric assessments acquired at baseline (i.e., week 0) and at weeks 7 and 14. The "Training" portion includes aerobic exercise training 3x per week on a cycle ergometer
Testing
Testing at weeks 0, 7, and 14 will be identical and completed over two days (Days 1 and 2).
On Day 1, blood will be drawn and analysed for resting plasma glucose, cholesterol, and lipid profiles. Next, participants will perform a "step-ramp-step" test that includes in series: a 6-min constant work rate bout at a low-intensity exercise (i.e., \~25 W) followed by a symptom-limited ramp-incremental test (\~5-15 W·min-1); and, after 30 min of recovery, a 12-min constant-work rate bout of heavy-intensity exercise (i.e., above gas exchange threshold [GET] but below the respiratory compensation point [RCP], \~40% of peak power output). This protocol will provide measures of cardiorespiratory fitness (V̇O2peak, GET, RCP) and be used to identify and establish the work rate ranges associated with the moderate, heavy, and severe-intensity domains. Throughout the exercise protocol, participants will wear a 12-lead ECG and facemask from which respired gas fractions, flows, and volumes will be measured. Week 7 tests will be used to adjust training intensity.
Day 2 experiments will run 48-96 hours later. First, participants' body composition will be measured by Dual X-ray Absorptiometry. Next, participants will perform a step-incremental cycle test at 3 individual-specific work rates within each of the moderate-, heavy-, and severe-intensity domains. After a 4 min 10 W baseline, participants will complete 10 min of constant-work rate exercise at 85%GET (i.e., moderate), then 10 min of constant-work rate at 70% of the difference between GET and RCP (i.e., heavy), and then cycle for as long as they can at 115%RCP (i.e., severe; \~4-6 minutes). At select time points during the protocol, arterialized-venous blood will be sampled from a heated dorsal hand vein and immediately analyzed for blood gas and metabolite concentration using a blood gas analyzer. After each blood draw, participants' cardiac output (Q̇) will be measured non-invasively by open-circuit acetylene breathing. Following exercise, participants will be rested supine in a reclining chair and undergo carbon monoxide rebreathing to measure hemoglobin mass and calculate intravascular volumes.
Training
Total training duration is 12 weeks (weeks 1-6 and 8-13). All aerobic exercise training will be conducted at Western University. Gas exchange measurements obtained from the "Testing" Day 1 will be used to identify each patients' target training work rate(s). Exercise prescription for the 3 groups will be work-matched (i.e., equal in kJ) relative to moderate-intensity training and prescribed as follows: i) moderate (constant work rate for 50 min at 85%GET; MOD); ii) heavy (constant work rate for 25-35 min at ∆70; HVY); and iii) severe (intervals; 4 x 4 min on at 115% RCP - 3 min off at 50-70%GET; HIIT). After the training target is established, patients will train 3x per week on cycle ergometer in groups as large as 5.
Analyses
An ANCOVA with sex and baseline fitness as covariates will be used to compare post-training outcome variables of the RCT. The primary outcome measure is V̇O2peak; secondary outcomes measures include V̇O2 at GET and RCP; and tertiary outcome measures include: fasting blood lipids and glucose, adiposity, hematological variables, and submaximal and maximal alveolar and deadspace ventilation, Q̇, stroke volume, and a-vO2diff. Initial primary analysis will be according to randomization, regardless of adherence, for those who complete post-testing (intent-to-treat). However, to assess physiological effects of training intensities, a per-protocol analysis will be used in those who meet training adherence criteria.
4,857 studies on the registry are indexed under Coronary Artery Disease; 890 are open to participants now.
This study's planned enrollment of 105 is below the median of 124 across 3,006 interventional studies indexed under Coronary Artery Disease.
Browse Coronary Artery Disease studies →Western University, Canada is the lead sponsor of 224 studies on the registry; 56 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
LVEF (left ventricular ejection fraction)
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
\~50 min of constant-power output cycling, 3 x per week at 85% of gas exchange threshold
Other: Aerobic exercise training
30 min of constant-power output cycling, 3 x per week at 70% of the difference between gas exchange threshold and respiratory compensation point
Other: Aerobic exercise training
intervals; 4 x 4 min on - 3 min off at 115% of respiratory compensation point (work) and 50-70% gas exchange threshold (recovery)
Other: Aerobic exercise training
Aerobic exercise training on a cycle ergometer
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 14
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 14
Gas exchange threshold
Post-training power output associated with the gas exchange threshold.
Time frame: baseline (week 0) and week 14
Respiratory compensation point
Post-training power output associated with the respiratory compensation point.
Time frame: baseline (week 0) and week 14
Cardiac output
Post-training submaximal and maximal cardiac output measured by open-circuit acetylene breathing.
Time frame: baseline (week 0) and week 14
Stroke volume
Post-training submaximal and maximal stroke volume.
Time frame: baseline (week 0) and week 14
Arterio-venous oxygen difference
Post-training submaximal and maximal arterio-venous oxygen difference.
Time frame: baseline (week 0) and week 14
Hemoglobin mass
Post-training hemoglobin mass measured by CO rebreathing.
Time frame: baseline (week 0) and week 14
Fasting blood lipids
Post-training LDL, HDL, and total cholesterol and triglycerides
Time frame: baseline (week 0) and week 14
Body fat percentage
Post-training body fat percentage measured by dual x-ray absorptiometry.
Time frame: baseline (week 0) and week 14
Started Nov 2024 (actual). Primary completion is estimated for Aug 2027, 33 months after the start.
Of 753 non-industry interventional studies with no phase under Coronary Artery Disease, half reached primary completion within 33 months of starting (the median), counting those still running; a quarter within 15 and three quarters within 53. This study's planned 33 months is close to that.
Counting every sponsor, half of 930 studies reached it within 30 months; a quarter within 15 and three quarters within 50.
How these figures are worked out, and which studies are left out of them.
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