Exercise Program for Heart Failure

Overseen By Ben Stephenson

Age: 65+

Sex: Any

Trial Phase: Academic

Sponsor: University of Virginia

Disqualifiers: Uncontrolled diabetes, Severe aortic stenosis, others

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

Compensation: Varies

Number of Visits: Unknown

92 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a new exercise program, combining aerobic and resistance training, can improve health outcomes for people with heart failure with reduced ejection fraction (HFrEF) more effectively than the current standard exercise routine. Participants will be randomly assigned to one of two groups: one will try the new program (COMBO), and the other will continue with the traditional routine (PRIME). Suitable candidates have heart failure with specific characteristics, such as an ejection fraction under 45% and some limitations in daily activities.

As an unphased trial, this study provides participants the chance to contribute to innovative research that could enhance exercise strategies for heart failure.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this exercise program is safe for individuals with heart failure?

Research has shown that exercise programs like PRIME and COMBO are safe for people with heart failure. In a study of the COMBO program, heart failure patients completed over 60,000 hours of exercise without any exercise-related deaths, indicating the program is well-tolerated.

For PRIME, early studies suggest that older patients with chronic heart failure can manage the exercise routine. Although detailed information on side effects for PRIME remains limited, its testing in trials suggests reasonable safety. Both programs aim to improve health through supervised exercise, which is generally safe. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the exercise programs COMBO and PRIME for heart failure because they offer a new approach to managing the condition. Unlike standard treatments that primarily focus on medications and lifestyle changes, these programs incorporate structured exercise regimens. The PRIME + COMBO approach starts with personalized training followed by progressive whole-body exercises, potentially offering enhanced cardiovascular benefits. Additionally, the COMBO-only program emphasizes continued progressive aerobic and resistance training, which might provide sustained improvements in heart function. These innovative exercise strategies could complement existing therapies and offer a more active way to improve heart health.

What evidence suggests that this trial's exercise programs could be effective for heart failure?

Research shows that exercise programs like the COMBO program, which participants in this trial may receive, can help people with heart failure by improving exercise capacity and enhancing quality of life. Studies have found that it can also improve heart function and reduce hospital visits. The PRIME program, another treatment option in this trial, focuses on a special type of exercise called peripheral remodeling. Early results suggest that PRIME might improve aerobic capacity, which is important for heart health. Both programs aim to support people with heart failure, but PRIME may offer unique benefits in how the body uses oxygen during exercise. ^{1 6 7 8 9}

Who Is on the Research Team?

Jason Allen, PhD

Principal Investigator

University of Virginia

Are You a Good Fit for This Trial?

This trial is for individuals over 65 with heart failure and reduced ejection fraction (HFrEF), specifically those who can communicate well, have cardiologist approval, and a hemoglobin level of at least 10.0 g/dL. It's not for people with uncontrolled diabetes, recent heart attacks or embolism, severe valve disease needing surgery, new atrial fibrillation, worsening symptoms in the past few days, significant ischemia during low exercise levels, or certain other acute conditions.

Inclusion Criteria

My cardiologist has approved my participation after reviewing my medical records and examining me.

I can understand and communicate about the study, and I can legally consent.

Your hemoglobin level must be at least 10.0 grams per deciliter.

Exclusion Criteria

I have not had a blood clot in the last 6 weeks.

I have severe narrowing of my aortic valve.

I need surgery for a heart valve problem causing backflow.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Phase 1: Treatment

Participants undergo 4 weeks of either PRIME or COMBO exercise training

4 weeks

Phase 2: Treatment

All participants undergo 8 weeks of progressive whole-body COMBO training

8 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

What Are the Treatments Tested in This Trial?

Interventions

• COMBO
• PRIME

Trial Overview The study compares a novel exercise program called PRIME against the traditional COMBO exercise regimen to see which one leads to better health outcomes for older patients with HFrEF. Participants will be randomly assigned to either the investigational PRIME program or the standard COMBO training.

How Is the Trial Designed?

Group I: PRIME + COMBO Experimental Treatment 2 Interventions

PRIME training (Phase 1), followed by 8 weeks of progressive whole-body COMBO training.

Group II: COMBO only Experimental Treatment 1 Intervention

4 weeks of standard progressive whole-body aerobic plus resistance training (COMBO) followed by 8 weeks continued COMBO training.

Who Is Running the Clinical Trial?

University of Virginia

Lead Sponsor

Trials

802

Recruited

1,342,000+

National Institute on Aging (NIA)

Collaborator

Trials

1,841

Recruited

28,150,000+

National Institutes of Health (NIH)

Collaborator

Trials

2,896

Recruited

8,053,000+

Published Research Related to This Trial

Patients with heart failure, both HFrEF and HFpEF, experience significant reductions in type I muscle fibers and oxidative enzymes, leading to impaired exercise metabolism and intolerance.

Exercise training can improve skeletal muscle function and exercise tolerance in HFrEF patients, while adjunctive strategies like nutritional supplementation show potential but are still in early research stages.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impaired Exercise Tolerance in Heart Failure: Role of Skeletal Muscle Morphology and Function. Tucker, WJ., Haykowsky, MJ., Seo, Y., et al.[2022]

Exercise training is safe for patients with heart failure and leads to significant improvements in health status and exercise capacity, while also helping to reduce abnormal heart function associated with the condition.

The benefits of exercise training, including a modest reduction in clinical events, are linked to the amount of exercise performed, highlighting the need for future research to determine the best exercise strategies for different patient groups.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Role and benefits of exercise in the management of patients with heart failure. Keteyian, SJ., Fleg, JL., Brawner, CA., et al.[2021]

Recent studies have established effective exercise testing protocols for patients with peripheral arterial disease and congestive heart failure, leading to significant improvements in exercise performance and quality of life.

The improvements in exercise capacity are primarily due to adaptations in skeletal muscle metabolism rather than increases in heart function or blood flow, highlighting the importance of targeted exercise training in these patient populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exercise physiology in cardiovascular diseases. Hiatt, WR.[2019]

Heart failure can lead to problems in peripheral circulation and skeletal muscle, which negatively affect a patient's ability to exercise.

Exercise training has been shown to provide benefits for various heart failure patients, suggesting that physical activity can be an important part of their treatment plan.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exercise and heart failure. Piña, IL., Daoud, S.[2007]

Aerobic exercise training (AET) significantly increased microRNA-1 expression and improved skeletal muscle regeneration in patients with chronic heart failure with reduced ejection fraction (HFrEF), leading to enhanced muscle cross-sectional area and better functional capacity.

Both AET and inspiratory muscle training (IMT) improved leg blood flow and quality of life, but only AET affected microRNA-1 and related pathways, indicating that AET is more effective for addressing skeletal muscle issues in HFrEF patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of aerobic and inspiratory training on skeletal muscle microRNA-1 and downstream-associated pathways in patients with heart failure. Antunes-Correa, LM., Trevizan, PF., Bacurau, AVN., et al.[2021]

A four-week exercise rehabilitation program for myocardial infarction patients with moderate-to-severe left-ventricular dysfunction showed no deterioration in heart function, with some patients even experiencing slight improvements in ejection fraction (EF) during rest and exercise.

While some patients with a resting EF less than 30% developed complications, those with normal pulmonary wedge pressure (PWP) managed to complete the program without issues, suggesting that careful monitoring and individualized training can be safe and beneficial for patients with severe heart dysfunction.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Special aspects of physical training during the rehabilitation stage of coronary patients]. Claus, J., Eisenriegler, E., Grodzinski, E., et al.[2007]

Rehabilitation for heart failure has been shown to effectively improve peripheral vascular and muscular abnormalities, demonstrating both efficacy and excellent tolerance in patients.

Exercise rehabilitation can enhance functional outcomes and quality of life, proving to be as effective as medical treatments for patients with left ventricular systolic dysfunction who have not fully responded to medication.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Physical rehabilitation of patients suffering from chronic heart failure]. Cohen Solal, A., Beauvais, F., Tabet, JY.[2019]

In a study involving 19 older adults with heart failure, the Peripheral Remodeling through Intermittent Muscular Exercise (PRIME) program significantly improved aerobic capacity (VO2peak) after 8 weeks, while the combined moderate-intensity aerobic and resistance training (COMBO) showed minimal change.

Both PRIME and COMBO improved muscle strength, but only PRIME led to clinically significant enhancements in aerobic capacity, suggesting it may be a more effective exercise option for older patients with heart failure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

PRIME-HF: Novel Exercise for Older Patients with Heart Failure. A Pilot Randomized Controlled Study. Giuliano, C., Levinger, I., Vogrin, S., et al.[2023]

A structured exercise training program for 12 elderly patients with congestive heart failure led to significant improvements in cardiac function, including an increase in ejection fraction and a decrease in brain natriuretic peptide levels, indicating better heart health.

The exercise program also enhanced skeletal muscle strength and mobility, as evidenced by increased quadriceps power and walking distance, which contributed to improved daily living activities and reduced care needs for these patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Exercise training improves activities of daily living in elderly patients with congestive heart failure]. Arahata, K., Uchiyama, S., Fujita, H., et al.[2019]

In a study of 27 elderly heart failure patients, both machine-assisted cycling and conventional exercise training improved exercise capacity equally, as measured by the 6-minute walk distance after 2 weeks.

Machine-assisted cycling showed a potential benefit in enhancing endothelial function, particularly in patients aged 80 and younger, suggesting it may be a more effective option for improving vascular health in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of machine-assisted cycling on exercise capacity and endothelial function in elderly patients with heart failure. Ozasa, N., Morimoto, T., Bao, B., et al.[2019]

A 3-month exercise training program significantly improved the distance walked by patients with stable systolic chronic heart failure, increasing from 615 meters to 970 meters, indicating enhanced physical capacity.

The exercise group showed a significant difference in double product (a measure of cardiac workload) compared to the control group, suggesting that exercise training can positively impact heart function in heart failure patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Benefits of exercise training in the treatment of heart failure: study with a control group. Silva, MS., Bocchi, EA., Guimaraes, GV., et al.[2022]

A 6-week dynamic exercise program focusing on individual muscle groups led to significant increases in quadriceps strength and muscle fiber area in 10 healthy subjects, while maintaining low heart stress levels.

This 'peripheral' training approach may be beneficial for patients with heart conditions, as it allows for muscle adaptation without the high central circulatory demands of traditional exercise, although its effects on cardiac patients still need to be explored.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adaptation to peripheral muscle training. Gaffney, FA., Grimby, G., Danneskiold-Samsøe, B., et al.[2008]

A meta-analysis of 446 heart failure patients showed that combined strength and intermittent aerobic training significantly improved peak VO2 compared to intermittent aerobic training alone, indicating a more effective approach for enhancing cardiovascular fitness.

Intermittent exercise training was found to be more beneficial than continuous exercise training, with a notable increase in peak VO2, suggesting that this type of training could be a preferred method for improving exercise capacity in heart failure patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intermittent versus continuous exercise training in chronic heart failure: a meta-analysis. Smart, NA., Dieberg, G., Giallauria, F.[2022]

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 ... Studies of patients with both HFrEF and HFpEF have demonstrated a consistent improvement in cardiorespiratory fitness, as measured by peak VO2, ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT05609097

PRIME HFrEF: Novel Exercise for Older Patients With Heart ... The objective of this study is to determine whether PRIME exercise training can outperform traditional (COMBO) exercise training to improve outcomes in HFrEF ...

4. jamanetwork.com jamanetwork.com/journals/jama/fullarticle/183708

Efficacy and Safety of Exercise Training in Patients With ... These studies also suggested that exercise training might improve survival and decrease heart failure hospitalizations. Two meta-analyses ...

5. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0146280624003931

Impact of exercise training on clinical outcomes and quality ... Exercise training is a beneficial intervention for CHF patients, improving health-related quality of life and reducing hospitalization.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3629752/

Exercise training in chronic heart failure - PubMed Central - NIH In their systematic review Smart and Marwick reported no exercise-related deaths during over 60,000 h of exercise training by HF patients [Smart and Marwick, ...

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

Supervised Exercise Training for Chronic Heart Failure ... This scientific statement critically examines the currently available literature on the effects of exercise-based therapies for chronic stable HFpEF.

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC2916661/

HF-ACTION Randomized Controlled Trial - PubMed Central Objective. To test the efficacy and safety of exercise training among patients with heart failure.

9. ahajournals.org ahajournals.org/doi/10.1161/circheartfailure.113.001420

Exercise Training as Therapy for Heart Failure | Circulation Exercise training improves exercise intolerance and QOL in patients with chronic stable HFrEF, and has become an accepted adjunct therapy for these patients.