Exercise Training for Heart Disease

(EXCEED2 Trial)

Overseen By Matheus Mistura, MSc

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Ottawa Heart Institute Research Corporation

Disqualifiers: Heart failure, Angina, COPD, others

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

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 24

Duration: 12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines how two types of exercise training affect women with heart disease. The goal is to determine which type—high-intensity intervals or steady moderate exercise—improves exercise capacity more. Participants will exercise virtually twice a week for 12 weeks and report on their quality of life and health. Women who have undergone heart disease treatments or events at least four weeks ago and who aren't currently exercising regularly might be a good fit. As an unphased trial, this study offers a unique opportunity for participants to contribute to valuable research that could enhance exercise recommendations for women with heart disease.

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 these exercise training methods are safe for women with coronary heart disease?

Research has shown that both high-intensity interval training (HIIT) and moderate-intensity continuous training (MICT) are safe for people with heart disease. HIIT carries a low risk of major heart problems for those with coronary artery disease and can quickly enhance heart and lung fitness. Studies also indicate that patients tolerate HIIT well.

Similarly, MICT is safe and effective for individuals with coronary heart disease. Moderate exercise poses a low risk of heart issues and helps reduce the chances of heart disease and death.

Previous studies confirm that both exercise methods are safe for people with heart disease. They are often used in cardiac rehabilitation, a program designed to help heart patients improve their health. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about exercise training for heart disease because it offers a unique approach compared to traditional treatments like medications and lifestyle changes. High-intensity interval training (HIIT) introduces short bursts of intense effort, which could enhance cardiovascular fitness more efficiently than moderate-intensity continuous exercise. On the other hand, moderate-intensity continuous exercise provides a steady, sustained workout that may be easier for some patients to maintain. Both methods emphasize personalized heart rate targets, potentially leading to better patient outcomes and more tailored heart disease management.

What evidence suggests that this trial's exercise training treatments could be effective for heart disease?

This trial will compare two exercise interventions for heart disease: high-intensity interval training (HIIT) and moderate-intensity continuous exercise training (MICT). Research has shown that HIIT can be as effective, or even better, than MICT for improving fitness in people with coronary heart disease. Specifically, HIIT greatly improves heart health and boosts overall fitness, with a low rate of major heart-related issues. Meanwhile, MICT also provides similar benefits for quality of life and mental health as HIIT. Both exercise types can lower the risk of heart disease and enhance overall health. ^{1 2 3 4 5}

Who Is on the Research Team?

Jennifer Reed, PhD

Principal Investigator

Ottawa Heart Institute Research Corporation

Are You a Good Fit for This Trial?

This trial is for women with coronary heart disease (CHD) who are interested in participating in a virtual exercise program. The study requires participants to train twice a week for 12 weeks, but specific inclusion and exclusion criteria details were not provided.

Inclusion Criteria

I am a woman who had a heart procedure or event at least 4 weeks ago.

Patient is able to perform a symptom limited CPET

I can read and understand English or French.

Exclusion Criteria

Patient currently participating in routine exercise training (>2x/week)

I have an irregular heartbeat that is not under control.

I am unable to sign a consent form.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are randomized into either virtual HIIT or MICT and exercise twice a week for 12 weeks

12 weeks

24 virtual sessions

Follow-up

Participants are monitored for changes in health measures and exercise capacity

14 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Exercise Training

Trial Overview The study is testing the effectiveness of two different virtual exercise programs: high-intensity interval training (HIIT) and moderate-to-vigorous intensity continuous training (MICT). Women will be randomly assigned to one of these programs to see which is better at improving exercise capacity and heart health.

How Is the Trial Designed?

Group I: standard care + moderate-intensity continuous exercise training Experimental Treatment 1 Intervention

2 days/week Warm-up: 60-70% peak HR - 10min Training: 70-85% peak HR - 35min Cool-down: 60-70% peak HR - 15min

Group II: standard care + high-intensity interval training Experimental Treatment 1 Intervention

2 days/week Warm-up: 60-70% peak HR - 10min Training: 85-95% peak HR - 25 minutes (4x4-minutes of high-intensity intervals interspersed with 3 minutes of low-intensity intervals) Cool-down: 60-70% peak HR - 10min

Who Is Running the Clinical Trial?

Ottawa Heart Institute Research Corporation

Lead Sponsor

Trials

200

Recruited

95,800+

Published Research Related to This Trial

Cardiac rehabilitation programs are essential for patients with cardiovascular disease, focusing on exercise training to improve both physical and mental health, while also reducing the risk of future heart events.

The ideal exercise regimen for stable cardiac patients includes a mix of aerobic training, arm exercises, strength training, and flexibility exercises, which together help stabilize or reverse atherosclerosis and enhance overall recovery post-myocardial infarction.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exercise following myocardial infarction. Current recommendations. Leon, AS.[2018]

In a study involving 25,420 patients undergoing cardiac rehabilitation, the rate of severe cardiovascular events during exercise training was very low, with only 20 serious events reported, indicating a high level of safety for patients participating in these programs.

The study found that the event rate was 1 per 49,565 patient-hours of exercise training, and there were no fatal complications or emergency defibrillations, suggesting that supervised exercise training is a safe practice for cardiac rehabilitation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety of exercise training for cardiac patients: results of the French registry of complications during cardiac rehabilitation. Pavy, B., Iliou, MC., Meurin, P., et al.[2022]

Participants with chronic health conditions expressed that adverse events (AEs) from resistance training (RT) significantly impact their willingness to engage in future exercise, highlighting the importance of understanding both the risks and benefits of RT.

The study identified that personal experiences, health conditions, and the environment in which RT occurs influence perceptions of safety and participation, suggesting that better communication about the risks of AEs is essential to encourage RT among individuals with chronic health issues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exploring participants' perspectives on adverse events due to resistance training: a qualitative study. El-Kotob, R., Pagcanlungan, JR., Craven, BC., et al.[2023]

Dynamic, nonisometric exercise training can enhance physical endurance and reduce cardiac workload during submaximal exertion in both individuals with coronary artery disease and healthy individuals, suggesting broad applicability of this training method.

Effective exercise regimens should involve training at 70-85% of maximal heart rate for at least 15-20 minutes, three times a week, and should be tailored to individual patient needs, ideally within medically supervised programs to ensure safety and efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exercise training in coronary artery disease. Laslett, L., Paumer, L., Amsterdam, EA.[2007]

Regular exercise training is highly recommended for heart failure patients, supported by strong evidence, yet many patients remain inactive due to various barriers.

Home telerehabilitation is proposed as an effective solution to encourage physical activity among heart failure patients, addressing the limitations of traditional outpatient rehabilitation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

How to do: telerehabilitation in heart failure patients. Piotrowicz, E.[2019]

In a 1.5-year study involving 274 male veterans with cardiovascular disease risk factors, only one serious adverse event (atrial fibrillation) occurred, indicating that a progressive walking program can be safely recommended for high-risk individuals.

While minor musculoskeletal issues were common, over half of the reported adverse events were unrelated to the exercise program, highlighting the need for strategies to help individuals with chronic illnesses safely resume physical activity after any health setbacks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse events among high-risk participants in a home-based walking study: a descriptive study. Goodrich, DE., Larkin, AR., Lowery, JC., et al.[2022]

Cardiac rehabilitation, which includes exercise training and various therapeutic adaptations, is crucial for patients with chronic heart failure and has been shown to improve functional capacity and reduce symptoms.

The program not only enhances physical health but also lowers cardiac morbidity and mortality by improving muscle function, endothelial health, and reducing sympathetic tone, which can help prevent arrhythmias.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Role of rehabilitation in the treatment of chronic heart insufficiency]. Iliou, MC.[2019]

Recent studies indicate that regular exercise training is safe and effective for patients with stable Class II and III heart failure, improving exercise tolerance and quality of life.

Moderate physical activity, such as 30 to 60 minutes of walking or cycling 3 to 5 days a week, can help reverse some muscle abnormalities and reduce stress on the heart, but more research is needed to fully understand its impact on long-term health outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exercise training in heart failure. Afzal, A., Brawner, CA., Keteyian, SJ.[2019]

A diverse exercise training regimen for heart disease patients, incorporating various activities for both arms and legs, can lead to significant cardiovascular benefits.

Understanding the different physiological responses to various forms of exercise allows for safer and more effective training, resulting in improved muscular endurance, strength, and reduced ischemia, ultimately enhancing the quality of life for these patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Types of exercise. Arm-leg and static-dynamic. Balady, GJ.[2007]

Exercise training significantly helps in preventing and modifying cardiovascular diseases and reducing mortality, highlighting its importance in patient care.

Patients with acute cardiovascular conditions benefit from structured cardiac rehabilitation programs, while those with chronic conditions should engage in lifelong home-based exercise routines that include aerobic, resistance, flexibility, and balance activities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exercise in cardiovascular diseases. Perez-Terzic, CM.[2022]

Regular exercise significantly benefits patients with heart disease by improving exercise tolerance, controlling risk factors, and potentially influencing the progression of coronary artery disease.

Patients should follow physician-guided exercise plans that include dynamic endurance activities and moderate-intensity circuit weight training, with a recommended duration of 2 to 3 hours per week, while high-risk patients should exercise at lower intensities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Heart patient and sports]. Niederhauser, HU.[2008]

Exercise training is effective and safe for heart failure (HF) patients, improving their fitness levels and symptoms, and may even reduce mortality and morbidity.

The review supports prescribing exercise training for patients with NYHA functional classes II-III and suggests that stable NYHA IV patients who are asymptomatic at rest could also benefit from training.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exercise training in patients with heart failure: clinical outcomes, safety, and indications. McKelvie, RS.[2021]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6760312/

High-Intensity Interval Training in Cardiac Rehabilitation - PMC HIIT has been found to be as effective, if not superior, to MICT with respect to improving clinical outcomes for older patients with CVD.

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. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/36753063/

High-intensity interval training in cardiac rehabilitation Conclusions: In stable CAD, low-volume HIIT improved cardiorespiratory fitness more than MISS by a clinically meaningful margin. Low-volume HIIT ...

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S016752731732346X

Effects of high-intensity interval versus continuous exercise ... High intensity interval training resulted in a significantly increase in HRR at the first and second minute of the recovery phase (15,44 ± 7,04 ...

5. 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 ...