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

Trial Summary

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 data supports the effectiveness of this treatment for heart failure?

Research shows that exercise training is safe and beneficial for heart failure patients, improving their heart and lung function, overall health, and quality of life. While it may not directly reduce death rates, it helps patients feel better and live more actively. ^{1 2 3 4 5}

Is exercise training safe for people with heart failure?

Yes, exercise training is generally considered safe for people with heart failure when they are properly evaluated and monitored. Studies have shown that it can be safely performed and is recommended as part of the treatment for stable heart failure patients. ^{1 6 7 8 9}

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

Exercise training is unique because it improves heart failure symptoms by enhancing exercise capacity and quality of life without worsening heart function. Unlike medications, it involves physical activity like aerobic and resistance exercises, which help the heart and muscles adapt positively, reducing the risk of hospitalization and possibly mortality. ^{1 4 10 11 12}

What is the purpose of this trial?

Heart failure with preserved ejection (HFpEF) disproportionately affects Veterans and is the number one reason for hospital discharge in the VA Health Care System. Exercise intolerance is a common complication experienced by patients with HFpEF, perpetuating physical inactivity and accelerating disease progression. This research proposal aims to elucidate mechanisms responsible for inadequate skeletal muscle blood flow and exercise intolerance in patients with HFpEF compared with healthy controls as well as following 8 weeks of exercise training in patients with HFpEF only.

Research Team

Kanokwan Bunsawat, PhD

Principal Investigator

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

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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]

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]

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]

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]

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]

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]

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 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]

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]

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]

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]

References

1. 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]

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

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

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

Heart failure and a controlled trial investigating outcomes of exercise training (HF-ACTION): design and rationale. [2007]

4. Canada pubmed.ncbi.nlm.nih.gov

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

5. England 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]

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

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

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

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

8. Switzerland pubmed.ncbi.nlm.nih.gov

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

9. Germany pubmed.ncbi.nlm.nih.gov

Establishing a cardiac training group for patients with heart failure: the "HIP-in-Würzburg" study. [2022]

10. 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]

11. Serbia pubmed.ncbi.nlm.nih.gov

[Effects of continuous physical training on exercise tolerance and left ventricular myocardial function in patients with heart failure]. [2019]

12. Netherlands pubmed.ncbi.nlm.nih.gov

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