Exercise Training for Heart Failure

Overseen By P Jon White, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: VA Office of Research and Development

Must not be taking: Hormone replacement therapy

Disqualifiers: Prior EF <50%, NYHA Class IV, others

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

Compensation: Varies

Number of Visits: 3

35 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to understand why individuals with heart failure, specifically with preserved ejection fraction (a condition where the heart pumps normally but remains stiff), struggle with exercise. The study will compare muscle blood flow and exercise capacity in these patients before and after an 8-week exercise training program. Participants will engage in supervised leg exercises three times a week. Ideal candidates are those diagnosed with heart failure that affects daily activity levels and have been informed that their heart still pumps well despite the condition. As an unphased trial, this study offers participants the chance to contribute to valuable research that could enhance exercise strategies for heart failure patients.

Will I have to stop taking my current medications?

The trial protocol does not specify whether you need to stop taking your current medications. However, it does mention that heart failure must be stabilized on optimized pharmacotherapy, which suggests that you may need to continue certain medications.

What prior data suggests that this exercise training is safe for patients with HFpEF?

Research has shown that exercise is generally safe for people with heart failure. Many studies have found that with proper evaluation, patients can exercise without issues. For those with heart failure and preserved ejection fraction (HFpEF), exercise has been linked to better physical function and heart health. It also improves exercise ability and enhances quality of life.

Previous research designed exercise programs to be safe and manageable. These programs usually include supervised sessions with gradual increases in intensity, ensuring the exercise is well-tolerated. Although most studies have been short, the results are promising, indicating that exercise safely helps manage heart failure symptoms. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Most treatments for heart failure with preserved ejection fraction (HFpEF) focus on managing symptoms with medications like diuretics, beta-blockers, or ACE inhibitors. However, this exercise training is different because it directly enhances cardiovascular fitness and muscle function through a supervised, tailored program. What's exciting is the program's adaptability, adjusting exercise intensity based on each patient's progress, potentially leading to significant improvements in their daily quality of life. Researchers are keen to see if this method can offer a complementary approach to traditional medication, providing holistic benefits for those with HFpEF.

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

Research shows that exercise can greatly benefit people with heart failure with preserved ejection fraction (HFpEF). Studies have found that exercise enables these patients to engage in more physical activities without fatigue or breathlessness. It also enhances their overall quality of life. These improvements occur because exercise helps the heart and muscles function more efficiently together. Overall, exercise offers a promising approach to managing HFpEF symptoms. ^{1 3 4 5 6}

Who Is on the Research Team?

Kanokwan Bunsawat, PhD

Principal Investigator

VA Salt Lake City Health Care System, Salt Lake City, UT

Are You a Good Fit for This Trial?

This trial is for adults with heart failure who can consent, have a specific type of heart failure (HFpEF) where the heart pumps well but is stiff, and show certain blood markers. It's not for those with severe heart issues, orthopedic limits that prevent exercise, women on hormone therapy, smokers, or pregnant women.

Inclusion Criteria

My heart condition limits my physical activity but I can still perform light tasks.

Plasma Brain Natriuretic Peptide (BNP) >200 pg/mL or NT-proBNP 400 pg/mL at enrollment

Left Ventricular Ejection Fraction (LVEF) > 50%

Exclusion Criteria

My heart failure is severe and cannot be managed with medication.

My heart failure is not due to a major untreated valve problem, except for a specific type of leaky heart valve caused by heart muscle weakness.

I have a heart condition such as acute coronary syndrome, infiltrative cardiomyopathy, or myocarditis.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Cross-sectional Comparison

Cross-sectional comparison of patients with HFpEF and healthy controls

Not specified

Exercise Training

Patients with HFpEF undergo 8 weeks of supervised knee extensor exercise training

8 weeks

3 visits per week (in-person)

Follow-up

Participants are monitored for changes in exercise tolerance and muscle blood flow

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Exercise training

Trial Overview The study looks at how well patients with HFpEF respond to an 8-week exercise program compared to healthy people. The focus is on understanding why these patients struggle with exercise by measuring changes in muscle blood flow.

How Is the Trial Designed?

Group I: Exercise training Experimental Treatment 1 Intervention

Patients with HFpEF will participate in the 8 weeks of supervised, two-legged, knee extensor exercise training for 3 days per week. Each exercise session will involve a 5-min warm-up and a 5-min cool-down, and exercise intensity will range between 40%-90% of maximal work rate. Maximal work rate will be re-assessed every two weeks.

Who Is Running the Clinical Trial?

VA Office of Research and Development

Lead Sponsor

Trials

1,691

Recruited

3,759,000+

Published Research Related to This Trial

In a study of 48 male patients with stable heart failure, those who engaged in continuous physical training for 6 months showed significant improvements in exercise tolerance and left ventricular (LV) ejection fraction compared to those who did not train.

The training group also experienced notable enhancements in both regional systolic and diastolic myocardial function, indicating that regular physical activity is beneficial for heart failure rehabilitation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Effects of continuous physical training on exercise tolerance and left ventricular myocardial function in patients with heart failure]. Deljanin-Ilić, M., Ilić, S., Stoickov, V.[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]

The HF-ACTION trial aims to determine if exercise training can reduce all-cause mortality and hospitalization in patients with heart failure, involving 36 supervised sessions followed by home-based exercise over a 4-year period.

Exercise training is a low-cost and accessible intervention that may improve health outcomes for heart failure patients, with various physiological and quality-of-life measures being assessed throughout the study.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Heart failure and a controlled trial investigating outcomes of exercise training (HF-ACTION): design and rationale. Whellan, DJ., O'Connor, CM., Lee, KL., et al.[2007]

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]

Exercise training is a safe and effective therapy for heart failure patients, improving their exercise tolerance and symptoms without worsening cardiac function.

Smaller studies suggest that exercise training may also reduce mortality and morbidity in heart failure patients, highlighting the importance of proper medical review and referral to cardiac rehabilitation programs, especially for those with severe heart failure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

...that exercise training is safe, useful and effective therapy and does not worsen cardiac function in heart failure? Estrella-Holder, E.[2011]

Exercise training significantly enhances cardiorespiratory function, functional status, and psychosocial well-being in heart failure patients, which is crucial since exercise tolerance is linked to their overall health outcomes.

While the direct impact of exercise training on morbidity and mortality in heart failure patients remains unclear, it appears to improve quality of life, suggesting that even small gains can lead to a more fulfilling life for these individuals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exercise training in heart failure: inpatient and outpatient considerations. Cahalin, LP.[2019]

Physical training significantly improves exercise tolerance in chronic heart failure patients, with a 13% increase in peak oxygen consumption and a 17% increase in exercise duration, without significant side effects.

A combined exercise program of cycle ergometer and calisthenics is more effective than cycling alone, and the benefits of training are consistent across different patient demographics and settings, indicating that a tailored home-based approach is both safe and beneficial.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Experience from controlled trials of physical training in chronic heart failure. Protocol and patient factors in effectiveness in the improvement in exercise tolerance. European Heart Failure Training Group. [2022]

A supervised exercise training program for 12 patients with heart failure was found to be feasible and safe, with no cardiovascular events occurring during the training year.

Participants showed improvements in quality of life and reductions in NT-proBNP levels, indicating a potential decrease in heart failure severity, while also experiencing a slight increase in left ventricular ejection fraction (LVEF).

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Establishing a cardiac training group for patients with heart failure: the "HIP-in-Würzburg" study. Güder, G., Wilkesmann, J., Scholz, N., et al.[2022]

Regular exercise training significantly improves quality of life and survival rates in both healthy individuals and patients with cardiovascular diseases, including those with stable heart failure.

In patients with heart failure classified as NYHA functional classes II and III, exercise training alleviates symptoms, enhances exercise capacity, and may reduce hospitalizations and mortality, highlighting its importance as a recommended treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exercise training in chronic heart failure: mechanisms and therapies. Piepoli, MF.[2022]

Exercise training is safe and effective for individuals with heart failure (HF), improving functional capacity, oxygen consumption, and quality of life, regardless of age.

Physical therapists should implement tailored exercise programs that include aerobic, resistance, and inspiratory muscle training, while closely monitoring patients to maximize benefits and ensure safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

ExPAAC proceedings: Exercise training for individuals with heart failure. Norman, JF.[2012]

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]

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. ahajournals.org ahajournals.org/doi/10.1161/CIR.0000000000001122

Supervised Exercise Training for Chronic Heart Failure ... Many studies have demonstrated improvements in physical function with exercise training in patients with HFpEF and have shown favorable cardiac ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4792111/

Exercise Training in Patients with Heart Failure and Preserved ... Exercise training has been shown to be effective in improving cardiorespiratory fitness (CRF) in patients with systolic heart failure.

5. nature.com nature.com/articles/s41591-024-03342-7

Combined endurance and resistance exercise training in ... In this multicenter, randomized trial, we evaluated the effects of combined endurance and resistance training over 12 months in patients with HFpEF.

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/17960476/

Exercise training in patients with heart failure Studies have demonstrated that exercise training can be performed safely in appropriately evaluated HF patients.