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

172 Participants Needed

Trial Summary

What is the purpose of this trial?

This study will compare the effects of two different types of training on exercise capacity in women with coronary heart disease (CHD). Participants will be randomized into either the virtual high-intensity interval training (HIIT) or the virtual moderate-to-vigorous intensity continuous training (MICT). After randomization, patients will exercise twice a week, for 12 weeks. The sessions will be conducted virtually. Patients will undergo a maximal exercise test, cardiometabolic indicators (height (cm), body mass (kg), body composition (%), waist circumference (cm) and, resting blood pressure) and complete questionnaires about quality of life, mental health, self-determined motivation, self-efficacy and enjoyment.

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 Exercise Training, Cardiac Rehabilitation, Physical Therapy, Exercise Intervention for heart disease?

Research shows that regular exercise training can improve heart health by enhancing exercise tolerance, reducing stress on the heart, and improving quality of life for heart disease patients. Exercise is recommended as a key part of cardiac rehabilitation, helping to prevent further heart issues and improve overall cardiovascular health. ^{1 2 3 4 5}

Is exercise training safe for people with heart disease?

Exercise training, including cardiac rehabilitation, is generally safe for heart disease patients when done under medical supervision. Studies show that it can be performed safely, especially when guidelines are followed, and it may even reduce mortality and improve quality of life. ^{6 7 8 9 10}

How does exercise training differ from other treatments for heart disease?

Exercise training, as part of cardiac rehabilitation, is unique because it combines physical activity with behavioral and psychosocial interventions to improve heart function and quality of life. Unlike medications, it focuses on enhancing physical endurance, reducing symptoms, and improving psychological well-being through a personalized exercise regimen. ^{11 12 13 14 15}

Research Team

Jennifer Reed, PhD

Principal Investigator

Ottawa Heart Institute Research Corporation

Eligibility Criteria

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 can read and understand English or French.

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

Exclusion Criteria

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

I have severe heart or lung conditions.

I am not willing to be assigned randomly to high-intensity or moderate-intensity exercise.

Timeline

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

References

1. Poland pubmed.ncbi.nlm.nih.gov

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

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

Exercise in cardiovascular diseases. [2022]

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

Exercise training in heart failure. [2019]

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

Physical Training and Cardiac Rehabilitation in Heart Failure Patients. [2018]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Exercise and cardiovascular diseases. [2016]

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

Safety of exercise training for cardiac patients: results of the French registry of complications during cardiac rehabilitation. [2022]

7. Switzerland pubmed.ncbi.nlm.nih.gov

[Heart patient and sports]. [2008]

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

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

9. Canada pubmed.ncbi.nlm.nih.gov

Exploring participants' perspectives on adverse events due to resistance training: a qualitative study. [2023]

10. England pubmed.ncbi.nlm.nih.gov

Adverse events among high-risk participants in a home-based walking study: a descriptive study. [2022]

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

The role of exercise therapy in patients with impaired ventricular function and chronic heart failure. [2007]

12. France pubmed.ncbi.nlm.nih.gov

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

13. Netherlands pubmed.ncbi.nlm.nih.gov

Exercise training in coronary artery disease. [2007]

14. Netherlands pubmed.ncbi.nlm.nih.gov

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

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

Exercise following myocardial infarction. Current recommendations. [2018]