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

40 Participants Needed

Trial Summary

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 data supports the effectiveness of the treatment Exercise Training for Heart Failure?

Research shows that regular exercise training can safely improve exercise tolerance, quality of life, and reduce symptoms in heart failure patients. It is a recommended treatment that can enhance health outcomes when tailored to individual needs and performed consistently. ^{1 2 3 4 5}

Is exercise training safe for heart failure patients?

Exercise training is generally considered safe for heart failure patients when done under supervision and with proper evaluation. Studies have shown that it can improve fitness and quality of life, and it is recommended in current guidelines for heart failure management. ^{6 7 8 9 10}

How is exercise training different from other treatments for heart failure?

Exercise training for heart failure is unique because it combines physical activity with lifestyle changes to improve heart function and quality of life. Unlike medications or surgeries, it involves regular aerobic and resistance exercises tailored to each patient's ability, which can enhance exercise capacity, reduce symptoms, and potentially lower hospitalization rates. ^{2 5 9 11 12}

What is the purpose of this trial?

This research study is being done to find out if exercise therapy can help improve the heart function, overall health, and quality of life of patients with pulmonary hypertension caused by heart failure.

Research Team

Bryan Taylor, PhD

Principal Investigator

Mayo Clinic

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

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]

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 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]

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]

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]

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]

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 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]

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]

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]

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]

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 training in heart failure. [2019]

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

Exercise And Heart Failure: Advancing Knowledge And Improving Care. [2018]

4. Germany pubmed.ncbi.nlm.nih.gov

[Exercise training as a key component of heart failure therapy]. [2018]

5. France pubmed.ncbi.nlm.nih.gov

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

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

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

7. England 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) [2007]

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

Cardiac rehabilitation: a comprehensive program for the management of heart failure. [2019]

9. England pubmed.ncbi.nlm.nih.gov

Exercise training in heart failure. [2020]

10. Switzerland pubmed.ncbi.nlm.nih.gov

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

11. Switzerland 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. [2023]

12. Germany pubmed.ncbi.nlm.nih.gov

[Exercise in heart failure - additional effect to medication?]. [2011]