Exercise Training for Heart Failure

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Texas Southwestern Medical Center

Must not be taking: PDE5 inhibitors

Disqualifiers: Age < 60, BMI > 50, Severe COPD, others

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

Compensation: Varies

Number of Visits: 2

Duration: 16 weeks

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 with preserved ejection fraction (HFpEF) often struggle with exercise and experience shortness of breath. Participants will engage in various exercise programs, such as whole-body workouts or single-leg exercises, to determine which improves exercise capacity. The trial includes individuals with heart failure symptoms, a heart pumping efficiency over 50%, and specific heart function issues. As an unphased trial, it provides a unique opportunity to contribute to the understanding and enhancement of exercise strategies for HFpEF patients.

Do I have to stop taking my current medications for the trial?

The trial protocol does not specify whether you need to stop taking your current medications. However, if you are using PDE5 inhibitors, you cannot participate in the trial.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are using PDE5 inhibitors.

What prior data suggests that these exercise training programs are safe for heart failure patients?

Research shows that exercise is generally safe for most people, including those with heart failure with preserved ejection fraction (HFpEF). Exercise programs, such as training one leg at a time or the whole body, have been studied in other contexts and usually carry few serious risks.

Many people handle exercise well. Some might experience mild soreness or tiredness, but these feelings typically subside as the body adapts to the activity. Following the advice of trainers or medical staff can help reduce any discomfort.

While exercise is not a new treatment, the researchers are exploring new ways to use it here. Any concerns should be discussed with the study team to ensure comfort about joining.

Why are researchers excited about this trial?

Researchers are excited about these exercise training treatments for heart failure with preserved ejection fraction (HFpEF) because they offer a novel approach to tackling exercise intolerance, a common issue in HFpEF patients. Traditional treatments for HFpEF often focus on medications to manage symptoms, but these exercise programs target the root causes of exercise limitations. One approach uses isolated single leg training, which is tailored for patients with either peripheral or central limitations, potentially improving specific areas of weakness. Another approach involves whole body cycle training, aiming to enhance overall cardiovascular fitness and muscle function. These methods could offer a more personalized and effective way to improve quality of life for HFpEF patients.

What evidence suggests that this trial's exercise training programs could be effective for heart failure with preserved ejection fraction (HFpEF)?

Research has shown that exercise can improve well-being in people with heart failure with preserved ejection fraction (HFpEF). This trial will explore different exercise regimens for HFpEF patients. Participants will join one of the study arms, which include single leg exercises or whole body exercises. Studies have found that both types of exercises can help patients perform physical activities with less fatigue and breathlessness. For those with heart-related limitations, whole body exercises might enhance the heart's ability to pump blood effectively. Meanwhile, single leg exercises can target specific muscles to boost overall stamina. This suggests that personalized exercise programs could be useful in managing HFpEF symptoms.

Are You a Good Fit for This Trial?

This trial is for people over 60 with heart failure who still have a decent amount of blood pumped from their heart each beat (ejection fraction > 0.50) and signs of poor relaxation of the heart muscle. They shouldn't be extremely overweight, taking certain drugs for erectile dysfunction, have severe valve disease or lung problems, very poor kidney function, or an inability to undergo MRI scans.

Inclusion Criteria

Your heart's pumping function is too high.

There is clear evidence of problems with how the heart relaxes between beats.

There is clear proof of problems with how your heart relaxes between beats.

Exclusion Criteria

Your body mass index (BMI) is higher than 50.

My kidney function is severely reduced.

I am younger than 60 years old.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Testing

Subjects undergo baseline maximal exercise testing and invasive right heart catheterization to define exercise tolerance and pulmonary and cardiac pressures during exercise

1-2 weeks

1 visit (in-person)

Treatment

Participants are randomized to either whole body cycle exercise or isolated single leg exercise training for 4 months

16 weeks

Regular exercise sessions

Follow-up Testing

Subjects repeat maximal exercise testing and invasive right heart catheterization to assess responses to 4 months of exercise training

1-2 weeks

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Exercise training

Trial Overview The study aims to understand why patients with HFpEF get tired easily during exercise and feel shortness of breath. It will test if specific types of exercise programs can help improve their ability to exercise without getting as tired or breathless.

How Is the Trial Designed?

Group I: Peripheral HFpEF whole body exercise Experimental Treatment 1 Intervention

HFpEF patients who have a peripheral limitation as the cause of the exercise intolerance randomized to whole body cycle training.

Group II: Peripheral HFpEF isolated single leg exercise Experimental Treatment 1 Intervention

HFpEF patients who have a peripheral limitation as the cause of the exercise intolerance randomized to isolated single leg training.

Group III: Central HFpEF whole body exercise Experimental Treatment 1 Intervention

HFpEF patients who have a central limitation as the cause of the exercise intolerance randomized to whole body cycle training.

Group IV: Central HFpEF isolated single leg exercise Experimental Treatment 1 Intervention

HFpEF patients who have a central limitation as the cause of the exercise intolerance randomized to isolated single leg training.

Who Is Running the Clinical Trial?

University of Texas Southwestern Medical Center

Lead Sponsor

Trials

1,102

Recruited

1,077,000+

The University of Texas at Arlington

Collaborator

Trials

48

Recruited

7,300+

University of Texas-Arlington

Collaborator

Trials

5

Recruited

740+

Published Research Related to This Trial

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]

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 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]

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 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 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]

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]

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]

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]

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]

Citations