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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how varying levels of aerobic exercise can help individuals with coronary artery disease improve heart health. Participants will train at one of three intensity levels—moderate, heavy, or high—to determine which level most effectively boosts aerobic fitness. The trial aims to discover whether personalized exercise plans outperform a one-size-fits-all approach. Suitable candidates have coronary artery disease, have been hospitalized for heart issues, and can perform cycling exercises without respiratory or joint problems. As an unphased trial, this study provides a unique opportunity to contribute to innovative exercise strategies that could enhance heart health for many.

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 prior data suggests that this exercise training method is safe for cardiac rehabilitation?

Research shows that aerobic exercise is generally safe for people with coronary artery disease. High-intensity interval training (HIIT) rarely causes serious heart problems when performed in cardiac rehab settings. Studies indicate it can improve heart health by lowering blood pressure and increasing blood flow.

Moderate-intensity continuous training (MICT) is also considered safe. Research shows that both HIIT and MICT carry a low risk of causing heart issues and can enhance heart and lung fitness.

While there isn't as much information specifically on heavy-intensity continuous training, similar programs have demonstrated safety for heart patients. Available studies suggest these exercise programs are safe and can help improve fitness levels in people with heart conditions. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these aerobic exercise trainings for coronary artery disease because they offer a fresh approach to heart health that goes beyond medication and surgery. Unlike the standard treatments like medications, stents, or bypass surgery, these exercise regimens focus on using the body’s natural ability to improve heart function and resilience. The high-intensity interval training, for instance, pushes the heart in short bursts, potentially boosting cardiovascular fitness more efficiently. Meanwhile, the moderate and heavy-intensity continuous trainings provide sustained exercise that could enhance heart endurance and overall health. These innovative exercise protocols could offer a complementary or alternative strategy to traditional treatments, promoting long-term heart health and reducing reliance on medications.

What evidence suggests that this exercise training method is effective for improving aerobic fitness in coronary artery disease?

This trial will compare different aerobic exercise regimens for coronary artery disease. Research has shown that high-intensity interval training (HIIT), one of the regimens in this trial, can greatly improve heart function and exercise capacity in people with coronary artery disease. Studies have found that HIIT often surpasses moderate-intensity continuous training (MICT), another regimen in this trial, in enhancing oxygen use during exercise and heart recovery after activity. However, MICT is associated with a significant reduction in resting heart rate, which benefits heart health. While heavy-intensity continuous training, also being tested in this trial, has not been studied as extensively, similar exercises have improved overall fitness and quality of life. These findings suggest that personalized exercise programs might be more effective for people with heart disease. ^{2 4 6 7 8}

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9203221/

The Effects of High-Intensity Interval Training on Exercise ... High-intensity interval training is an effective therapy for improving peak VO 2 values in patients with CAD.

2. ahajournals.org ahajournals.org/doi/10.1161/JAHA.118.009305

High‐Intensity Interval Training for Patients With ... HIIT has shown a relatively low rate of major adverse cardiovascular events for patients with coronary artery disease or heart failure when applied within CR ...

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1877065724000629

Review Effects of high-intensity interval training on ... Moderate- to high-quality evidence supported that HIIT is superior to MICT in improving VO 2 peak for CAD.

4. jamanetwork.com jamanetwork.com/journals/jamacardiology/fullarticle/2769884

Short-term and Long-term Feasibility, Safety, and Efficacy ... Findings In this randomized clinical trial including 93 participants, cardiorespiratory fitness significantly improved by 10% with HIIT compared ...

5. nature.com nature.com/articles/s41598-022-21655-w

Feasibility and impact of whole-body high-intensity interval ... Twelve weeks of low-volume whole-body HIIT increased cardiorespiratory capacity and improved quality of life in patients with stable CAD compared to standard ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10749735/

Improving Health Outcomes in Coronary Artery Disease ... In conclusion, this RCT showed that both 6-week HIIT and MICT programs were safe and effective to promote beneficial effects on the patient's ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12027975/

Narrative Review of High-Intensity Interval Training: Positive ... Results: HIIT significantly improved vascular function, evidenced by reductions in systolic and diastolic blood pressure and enhanced flow- ...

8. sciencedirect.com sciencedirect.com/science/article/pii/S0147956323002844

Physiological and psychological outcomes of high intensity ... HIIT has been shown to be both safe and effective for improving cardiovascular fitness in both coronary artery disease and HF patients. Objectives. To provide a ...