Coronary Artery DiseaseDOSE-EX-CADNCT06143332
Domain-specific Aerobic Exercise Training in Coronary Artery Disease
A study testing Aerobic exercise training in people with Coronary Artery Disease, run by Western University, Canada at 1 site in Canada.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- Aerobic exercise training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 105 participants
- Where
- 1 siteCanada
- Study dates
- 1 Nov 2024to Mar 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
The University of Western Ontario
London, Ontario, N6A3K7
Daniel Keir, 519-661-2111, dkeir@uwo.ca
About this study
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.
Read the detailed description
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.
- Conditions
- Coronary Artery Disease
- Being tested
- Aerobic exercise training
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aerobic exercise trainingOther
Aerobic exercise training on a cycle ergometer
| Study group | Role | What they receive |
|---|---|---|
| Moderate-intensity continuous training | Experimental | ~50 min of constant-power output cycling, 3 x per week at 85% of gas exchange threshold Receives: Other: Aerobic exercise training |
| Heavy-intensity continuous training | Experimental | 30 min of constant-power output cycling, 3 x per week at 70% of the difference between gas exchange threshold and respiratory compensation point Receives: Other: Aerobic exercise training |
| High (severe)-intensity interval training | Experimental | intervals; 4 x 4 min on - 3 min off at 115% of respiratory compensation point (work) and 50-70% gas exchange threshold (recovery) Receives: Other: Aerobic exercise training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peak oxygen uptake
Post-training peak oxygen uptake achieved during a symptom-limited incremental exercise test to task failure
Measured: baseline (week 0) and week 14
Secondary outcomes (3)
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
Measured: week 14
Gas exchange threshold
Post-training power output associated with the gas exchange threshold.
Measured: baseline (week 0) and week 14
Respiratory compensation point
Post-training power output associated with the respiratory compensation point.
Measured: baseline (week 0) and week 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2023
- Study start1 Nov 2024
- Primary completionAug 2027 (estimated)
- Study completionMar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- More trials run by Western University, CanadaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 105 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Western University, Canada
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Daniel Keir, Western University, Canada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06143332
- Sponsor's protocol ID
- 123930
- Acronym
- DOSE-EX-CAD
- Status last verified
- Aug 2026
- First submitted
- 8 Nov 2023
- Last updated
- 27 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Domain-specific Aerobic Exercise Training in Coronary Artery Disease
- ClinicalTrials.gov ID
- NCT06143332
- Acronym / sponsor ID
- DOSE-EX-CAD / 123930
- Conditions
- Coronary Artery Disease
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 105 participants (estimated)
- Lead sponsor
- Western University, CanadaUniversity, hospital or other
- Study start
- 1 Nov 2024 (actual)
- Primary completion
- Aug 2027 (estimated)
- Study completion
- Mar 2028 (estimated)
- First posted
- 22 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Moderate-intensity continuous training | Experimental | Other: Aerobic exercise training~50 min of constant-power output cycling, 3 x per week at 85% of gas exchange threshold |
| Heavy-intensity continuous training | Experimental | Other: Aerobic exercise training30 min of constant-power output cycling, 3 x per week at 70% of the difference between gas exchange threshold and respiratory compensation point |
| High (severe)-intensity interval training | Experimental | Other: Aerobic exercise trainingintervals; 4 x 4 min on - 3 min off at 115% of respiratory compensation point (work) and 50-70% gas exchange threshold (recovery) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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..
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Aerobic exercise trainingAerobic exercise training on a cycle ergometer | Other | Heavy-intensity continuous training, High (severe)-intensity interval training, Moderate-intensity continuous training |
Primary outcome
Peak oxygen uptake
Time frame: baseline (week 0) and week 14
Post-training peak oxygen uptake achieved during a symptom-limited incremental exercise test to task failure
3 secondary outcomes
Positive responders
Time frame: week 14
Gas exchange threshold
Time frame: baseline (week 0) and week 14
Respiratory compensation point
Time frame: baseline (week 0) and week 14
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aerobic exercise training in people with Coronary Artery Disease, run by Western University, Canada at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Daniel A Keir, PhD (519-661-2111, dkeir@uwo.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Peak oxygen uptake (time frame: baseline (week 0) and week 14). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Aug 2026.