Aerobic Exercise for Coronary Artery Disease

(DOSE-EX-CAD Trial)

Overseen By Daniel A Keir, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Western University, Canada

Must not be taking: Insulin

Disqualifiers: Heart failure, Aortic stenosis, Arrhythmias, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 39

105 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment Domain-specific Aerobic Exercise Training for Coronary Artery Disease?

Research shows that high intensity aerobic interval exercise is more effective than moderate intensity exercise in increasing aerobic capacity, which is important for reducing mortality in patients with coronary artery disease. ^{1 2 3 4 5}

Is aerobic exercise safe for people with coronary artery disease?

Aerobic exercise, including high-intensity interval training (HIIT), has shown a relatively low rate of major adverse cardiovascular events for patients with coronary artery disease when done in a controlled setting, like cardiac rehabilitation. However, caution is advised, and it should be done under supervision, especially for those with cardiometabolic diseases. ^{6 7 8 9 10}

How is the treatment 'Domain-specific Aerobic Exercise Training' unique for coronary artery disease?

This treatment is unique because it involves a personalized approach to aerobic exercise, focusing on specific intensity levels tailored to each patient's needs, which can maximize benefits and minimize risks compared to standard exercise routines. ^{1 11 12 13 14}

What is the purpose of 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 is for patients with Coronary Artery Disease (CAD) who have good heart pump function, were recently hospitalized for a heart attack or had procedures like stenting or bypass surgery, and can exercise safely. It's not for those with breathing or bone/muscle problems that stop them from cycling.

Inclusion Criteria

I have CAD, no heart pumping issues, and can exercise safely after a heart attack treatment.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Testing

Physiological, health, and anthropometric assessments at baseline, week 7, and week 14

14 weeks

3 visits (in-person)

Training

Participants undergo personalized domain-based aerobic exercise training 3x per week

12 weeks

36 sessions (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Domain-specific Aerobic Exercise Training

Trial Overview The study tests if personalized aerobic exercise training based on three intensity zones improves fitness more than the 'one-size fits all' method in cardiac rehab. Patients will be divided into groups to train at different intensities and their fitness changes will be compared after 3 months.

Participant Groups

Group I: Moderate-intensity continuous training Experimental Treatment 1 Intervention

\~50 min of constant-power output cycling, 3 x per week at 85% of gas exchange threshold

Group II: High (severe)-intensity interval training Experimental Treatment 1 Intervention

intervals; 4 x 4 min on - 3 min off at 115% of respiratory compensation point (work) and 50-70% gas exchange threshold (recovery)

Group III: Heavy-intensity continuous training Experimental Treatment 1 Intervention

30 min of constant-power output cycling, 3 x per week at 70% of the difference between gas exchange threshold and respiratory compensation point

Who Is Running the Clinical Trial?

Western University, Canada

Lead Sponsor

Trials

270

Recruited

62,500+

Findings from Research

In a study of 21 stable coronary artery disease (CAD) patients, high-intensity aerobic interval exercise (80-90% of VO2peak) resulted in a significant 17.9% increase in peak oxygen uptake (VO2peak) compared to a 7.9% increase with moderate-intensity exercise (50-60% of VO2peak) over 10 weeks.

The findings suggest that high-intensity exercise is more effective than moderate exercise for improving VO2peak in CAD patients, which is important for reducing the risk of cardiovascular disease and mortality.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

High intensity aerobic interval exercise is superior to moderate intensity exercise for increasing aerobic capacity in patients with coronary artery disease. Rognmo, Ø., Hetland, E., Helgerud, J., et al.[2022]

A systematic review of 11 studies involving 156 clinically stable patients with cardiometabolic diseases found that high-intensity interval exercise (HIIE) can lead to adverse responses in about 8% of individuals, indicating a higher risk compared to moderate-intensity exercise.

It is recommended that patients with cardiometabolic diseases who wish to engage in HIIE should be clinically stable, have prior experience with moderate-intensity exercise, and exercise under supervision to ensure safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

What Doesn't Kill You Makes You Fitter: A Systematic Review of High-Intensity Interval Exercise for Patients with Cardiovascular and Metabolic Diseases. Levinger, I., Shaw, CS., Stepto, NK., et al.[2022]

High-intensity interval training (HIIT) is as effective, if not more so, than traditional moderate-intensity continuous training (MICT) for patients with cardiovascular disease, based on a systematic review of 23 studies involving 1117 participants.

The safety profile of HIIT in cardiac rehabilitation is promising, with only one major cardiovascular adverse event reported per 17,083 training sessions, indicating that HIIT can be safely implemented in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

High-Intensity Interval Training for Patients With Cardiovascular Disease-Is It Safe? A Systematic Review. Wewege, MA., Ahn, D., Yu, J., et al.[2021]

This extensive 18-year study involving 50,142 exercise tests in a clinical Chinese population found a very low rate of adverse events, at just 0.6 events per 10,000 tests, indicating that exercise testing is generally safe.

The study highlights that the majority of patients undergoing these tests had existing health conditions, yet the low incidence of serious adverse events suggests improvements in clinical practices over time have enhanced safety during exercise testing.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety of Exercise Testing in the Clinical Chinese Population. Dun, Y., Olson, TP., Ripley-Gonzalez, JW., et al.[2021]

The ADVANCE study aims to evaluate how adverse events (AEs) are reported in exercise oncology trials, which is crucial for assessing the safety of exercise interventions for cancer patients.

By reviewing published trials and using a standardized checklist for reporting AEs, the study seeks to identify gaps in current practices and inform future research on improving the consistency and transparency of AE reporting in this field.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse Events Reporting of Clinical Trials in Exercise Oncology Research (ADVANCE): Protocol for a Scoping Review. Luo, H., Schumacher, O., Galvão, DA., et al.[2022]

Researchers in resistance training studies often lack clear guidance and motivation for thorough adverse event (AE) reporting, which can lead to inconsistent practices.

There is a need for exercise-specific guidelines for AE reporting, as current standards are perceived as not applicable to exercise trials, highlighting the importance of tailored strategies to improve reporting consistency.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Researchers' perspectives on adverse event reporting in resistance training trials: a qualitative study. El-Kotob, R., Pagcanlungan, JR., Craven, BC., et al.[2022]

References

1. New Zealand pubmed.ncbi.nlm.nih.gov

Aerobic Interval vs. Continuous Training in Patients with Coronary Artery Disease or Heart Failure: An Updated Systematic Review and Meta-Analysis with a Focus on Secondary Outcomes. [2019]

2. England pubmed.ncbi.nlm.nih.gov

High intensity aerobic interval exercise is superior to moderate intensity exercise for increasing aerobic capacity in patients with coronary artery disease. [2022]

3. England pubmed.ncbi.nlm.nih.gov

Do Clinical Exercise Tests Permit Exercise Threshold Identification in Patients Referred to Cardiac Rehabilitation? [2023]

4. United States pubmed.ncbi.nlm.nih.gov

Pedometer Feedback Interventions Increase Daily Physical Activity in Phase III Cardiac Rehabilitation Participants. [2021]

5. England pubmed.ncbi.nlm.nih.gov

Long-term effect of rehabilitation in coronary artery disease patients: randomized clinical trial of the impact of exercise volume. [2010]

6. United States pubmed.ncbi.nlm.nih.gov

What Doesn't Kill You Makes You Fitter: A Systematic Review of High-Intensity Interval Exercise for Patients with Cardiovascular and Metabolic Diseases. [2022]

7. England pubmed.ncbi.nlm.nih.gov

High-Intensity Interval Training for Patients With Cardiovascular Disease-Is It Safe? A Systematic Review. [2021]

8. Switzerland pubmed.ncbi.nlm.nih.gov

Safety of Exercise Testing in the Clinical Chinese Population. [2021]

9. Switzerland pubmed.ncbi.nlm.nih.gov

Adverse Events Reporting of Clinical Trials in Exercise Oncology Research (ADVANCE): Protocol for a Scoping Review. [2022]

10. Canada pubmed.ncbi.nlm.nih.gov

Researchers' perspectives on adverse event reporting in resistance training trials: a qualitative study. [2022]

11. United States pubmed.ncbi.nlm.nih.gov

Aerobic exercise intensity assessment and prescription in cardiac rehabilitation: a joint position statement of the European Association for Cardiovascular Prevention and Rehabilitation, the American Association of Cardiovascular and Pulmonary Rehabilitation, and the Canadian Association of Cardiac Rehabilitation. [2022]

12. England pubmed.ncbi.nlm.nih.gov

Aerobic exercise intensity assessment and prescription in cardiac rehabilitation: a joint position statement of the European Association for Cardiovascular Prevention and Rehabilitation, the American Association of Cardiovascular and Pulmonary Rehabilitation and the Canadian Association of Cardiac Rehabilitation. [2022]

13. England pubmed.ncbi.nlm.nih.gov

Aerobic exercise training intensity in patients with chronic heart failure: principles of assessment and prescription. [2022]

14. France pubmed.ncbi.nlm.nih.gov

[Exercise training and rehabilitation techniques in patients with coronary disease]. [2016]