Exercise Training for Heart Failure

Overseen By Robyn Bryde, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Mayo Clinic

Disqualifiers: Obesity, Hypertension, Diabetes, 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: 31

Duration: 10 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether exercise therapy, also known as Exercise Training, can improve heart function, overall health, and quality of life for individuals with pulmonary hypertension caused by heart failure. Participants will either join a supervised exercise program for 10 weeks or continue with their usual medical care while undergoing exercise testing. The trial seeks individuals with stable heart failure for over three months and a heart condition affecting pumping efficiency (LVEF < 40%). As an unphased trial, it offers participants the chance to contribute to valuable research that could enhance treatment options for heart failure.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it requires that your condition and medications have been stable for more than 3 months.

What prior data suggests that exercise training is safe for patients with pulmonary hypertension caused by heart failure?

Research has shown that exercise is generally safe for people with heart failure. In one study, out of more than 300 exercise sessions, only one resulted in a minor issue, specifically a brief fainting spell. Other studies have found that exercise not only improves heart function and increases exercise capacity but also enhances the quality of life for those with heart failure. To date, exercise has been well-received, with very few negative incidents reported. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about exercise training for heart failure because it offers a non-pharmaceutical approach that can complement standard medications like ACE inhibitors, beta-blockers, and diuretics. Unlike these drugs, exercise training aims to improve cardiovascular health by enhancing heart function and overall fitness directly through physical activity. This method not only targets symptoms but also empowers patients to actively participate in their own health management, potentially leading to better quality of life and reduced hospitalizations. Plus, it can provide benefits in a relatively short period, as the study involves just 10 weeks of supervised sessions.

What evidence suggests that exercise training might be an effective treatment for heart failure?

Research has shown that exercise can greatly benefit people with heart failure. In this trial, participants in the exercise training arm will undergo supervised exercise sessions. Studies have found that these sessions can improve heart function and increase exercise endurance. As a result, patients can remain active for longer periods. Exercise also eases daily activities, enhancing overall quality of life, and may reduce the likelihood of hospitalization. Overall, exercise offers a promising approach to managing heart failure symptoms effectively. ^{1 2 3 6 7}

Who Is on the Research Team?

Bryan Taylor, PhD

Principal Investigator

Mayo Clinic

Are You a Good Fit for This Trial?

This trial is for heart failure patients with reduced heart function (LVEF < 40%) who've been stable for over 3 months and can exercise on a bike or treadmill. It's not for those in the most severe stage of heart failure, pregnant women, individuals with certain other health issues like severe obesity or uncontrolled diabetes, or conditions that limit exercise.

Inclusion Criteria

My health condition has been stable for over 3 months.

My heart condition allows me to perform daily activities with slight to moderate limitations.

Your heart's pumping function is very weak.

Exclusion Criteria

I have a condition that limits my ability to exercise.

Pregnant or nursing women

I have conditions like severe obesity, uncontrolled high blood pressure, type 2 diabetes, or severe COPD.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Exercise Testing

Participants undergo exercise testing to assess baseline cardiopulmonary function

1 week

1 visit (in-person)

Treatment

Participants are randomized to either 10 weeks of supervised exercise training or continue standard medical care

10 weeks

30 visits (in-person) for exercise group

Follow-up

Participants are monitored for changes in pulmonary and cardiac function after the intervention

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Exercise Training

Trial Overview The study is testing if regular exercise can improve how well the heart works, overall health, and life quality in people with pulmonary hypertension due to heart failure. Participants will follow an exercise program using bikes or treadmills.

How Is the Trial Designed?

Group I: Exercise Training Experimental Treatment 1 Intervention

Two sets of exercise testing (before and after) 10 weeks of supervised exercise training (3 sessions per week) at Mayo Clinic Florida.

Group II: Control Groups Active Control 1 Intervention

Two sets of exercise testing while continuing with standard medical care in between.

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials

3,427

Recruited

3,221,000+

Florida Heart Research Institute

Collaborator

Trials

3

Recruited

220+

Published Research Related to This Trial

A 12-week concurrent exercise training program combining aerobic and resistance exercises significantly improved functional capacity and muscular strength in 95 male patients with chronic heart failure, compared to traditional aerobic training alone.

Patients in the concurrent training group experienced greater improvements in quality of life and lower body strength, with no reported side effects leading to discontinuation of the training program.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of Concurrent, Within-Session, Aerobic and Resistance Exercise Training on Functional Capacity and Muscle Performance in Elderly Male Patients with Chronic Heart Failure. Volterrani, M., Caminiti, G., Perrone, MA., et al.[2023]

Recent studies have demonstrated that regular exercise is safe and beneficial for patients with chronic heart failure, contradicting earlier beliefs that it could be harmful.

Exercise training significantly improves exercise capacity, quality of life, and reduces symptoms and hospitalization rates in heart failure patients, making it a crucial part of their treatment plan.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Exercise in heart failure - additional effect to medication?]. Seebach, R., Hensler, D., Christle, JW., et al.[2011]

A study involving 80 patients with chronic heart failure showed that a structured endurance training program was safe, with no reported adverse events, and led to significant improvements in exercise time and quality of life.

The training increased the anaerobic threshold and decreased the ventilatory equivalent for carbon dioxide during submaximal exercise, indicating enhanced exercise capacity, although it did not significantly improve peak oxygen consumption.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and effects of physical training in chronic heart failure. Results of the Chronic Heart Failure and Graded Exercise study (CHANGE) Wielenga, RP., Huisveld, IA., Bol, E., et al.[2007]

Exercise training is safe for patients with chronic heart failure (CHF) and has been shown to improve exercise capacity, which is crucial given the debilitating symptoms associated with the condition.

The review of controlled clinical trials suggests that exercise training may also lead to improvements in the underlying pathophysiological changes of CHF, potentially reducing morbidity and mortality rates.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exercise training in heart failure. Coats, AJ.[2020]

Exercise training is a safe and effective treatment for patients with heart failure, significantly improving their quality of life and functioning, yet it is underutilized despite being a guideline-recommended intervention.

A tailored exercise program that considers individual patient preferences and physiological capabilities is crucial for success, highlighting the need to overcome barriers related to patient access, physician awareness, and insurance coverage.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exercise And Heart Failure: Advancing Knowledge And Improving Care. Alvarez, P., Hannawi, B., Guha, A.[2018]

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]

Exercise training is safe and beneficial for patients with heart failure, improving functional capacity, quality of life, and even survival rates, as shown in various studies.

Supervised exercise programs, particularly in cardiac rehabilitation settings, yield the best outcomes due to personalized exercise prescriptions and comprehensive management of patients' health needs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cardiac rehabilitation: a comprehensive program for the management of heart failure. Boudreau, M., Genovese, J.[2019]

Supervised exercise training and individual physical activity are strongly recommended for all patients with heart failure, starting in the hospital after stabilization and continuing in rehabilitation programs post-discharge.

These exercise programs, which include endurance, resistance, and respiratory training, not only help improve physical fitness but also aim to enhance health literacy for better long-term adherence to physical activity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Exercise Training and Physical Activity in Patients with Heart Failure]. Wilhelm, M.[2018]

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]

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]

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]

Physical exercise is a crucial therapy for chronic heart failure, significantly improving exercise capacity, quality of life, and reducing hospitalizations, yet it is underutilized in clinical practice despite strong evidence from meta-analyses.

Both moderate continuous endurance training and interval training are safe and effective for chronic heart failure patients, and combining endurance with resistance training can enhance benefits, emphasizing the importance of tailored exercise regimens and monitoring.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Exercise training as a key component of heart failure therapy]. Dörr, M., Halle, M.[2018]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6396064/

Exercise Training and Heart Failure: A Review of the Literature Exercise training and cardiac rehabilitation have demonstrated numerous benefits for people with CHF, including improved exercise capacity and QoL.

2. ahajournals.org ahajournals.org/doi/10.1161/CIRCRESAHA.124.325533

Exercise Training in Heart Failure: Clinical Benefits and ... This review examines clinical benefits of exercise training across HF subtypes, focusing on clinical trials with key outcomes including mortality, ...

3. nature.com nature.com/articles/s41598-024-82608-z

Effects of exercise based cardiac rehabilitation delivery ... Our analysis identifies HCR (AE + RE) as the most effective intervention for improving quality of life (MLHFQ), exercise capacity (6MWT), and reducing hospital ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11985756/

Exercise interventions for patients with heart failure Studies have shown (4, 5) that exercise rehabilitation can improve cardiac function, enhance exercise tolerance, and improve quality of life.

5. jacc.org jacc.org/doi/10.1016/j.jacc.2021.01.030

Cardiac Rehabilitation for Patients With Heart Failure In patients with HF, combined endurance-resistance exercise programs significantly improve submaximal exercise capacity, muscle strength, and QOL (2,3). Both ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9358945/

Efficacy and safety of different modes of exercise-based ... The purpose of this study is to find out the relative efficacy and safety of different modes of CR delivery for individuals with HF using a network meta- ...

7. frontiersin.org frontiersin.org/journals/sports-and-active-living/articles/10.3389/fspor.2025.1557887/full

Exercise interventions for patients with heart failure Studies have shown (4, 5) that exercise rehabilitation can improve cardiac function, enhance exercise tolerance, and improve quality of life.