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

Trial Summary

What is the purpose of this trial?

This study is trying to find out whether performing a hybrid aerobic-resistance exercise training program (titled PRIME: Peripheral Remodeling via Intermittent Muscular Exercise) results in better health outcomes than the traditional exercise training program (called COMBO) that is used in individuals with heart failure with reduced ejection fraction (HFrEF). Participants will be randomized (like the flip of a coin) to either PRIME (investigational) or the traditional exercise program (standard of care).

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 data supports the effectiveness of the treatment COMBO, Traditional Exercise Training Program, Standard of Care Exercise Program, PRIME, Peripheral Remodeling via Intermittent Muscular Exercise for heart failure?

Research shows that exercise training is safe and improves health status and exercise capacity in heart failure patients, helping to reduce abnormal changes in the body caused by the condition. Additionally, peripheral muscle training can lead to significant muscle adaptation with minimal stress on the heart, which may benefit heart failure patients who cannot engage in traditional exercise. ^{1 2 3 4 5}

Is exercise training safe for people with heart failure?

Exercise training is generally safe for people with heart failure, as studies have shown it improves health status and exercise capacity, and reduces some of the negative effects of heart failure. ^{2 6 7 8 9}

How does the exercise program for heart failure differ from other treatments?

This exercise program for heart failure is unique because it combines moderate-intensity aerobic and resistance training, and includes a preliminary phase called Peripheral Remodeling through Intermittent Muscular Exercise (PRIME) to enhance aerobic capacity and muscle strength more effectively than traditional exercise programs. ^{7 10 11 12 13}

Research Team

Jason Allen, PhD

Principal Investigator

University of Virginia

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

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]

References

1. Sweden pubmed.ncbi.nlm.nih.gov

Adaptation to peripheral muscle training. [2008]

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

Role and benefits of exercise in the management of patients with heart failure. [2021]

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

Exercise physiology in cardiovascular diseases. [2019]

4. Netherlands pubmed.ncbi.nlm.nih.gov

Intermittent versus continuous exercise training in chronic heart failure: a meta-analysis. [2022]

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

[Physical rehabilitation of patients suffering from chronic heart failure]. [2019]

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

Impaired Exercise Tolerance in Heart Failure: Role of Skeletal Muscle Morphology and Function. [2022]

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

PRIME-HF: Novel Exercise for Older Patients with Heart Failure. A Pilot Randomized Controlled Study. [2023]

8. Italy pubmed.ncbi.nlm.nih.gov

Exercise and heart failure. [2007]

9. Germany 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. [2021]

10. Germany pubmed.ncbi.nlm.nih.gov

[Special aspects of physical training during the rehabilitation stage of coronary patients]. [2007]

11. Japan pubmed.ncbi.nlm.nih.gov

[Exercise training improves activities of daily living in elderly patients with congestive heart failure]. [2019]

12. Japan pubmed.ncbi.nlm.nih.gov

Effects of machine-assisted cycling on exercise capacity and endothelial function in elderly patients with heart failure. [2019]

13. Brazil pubmed.ncbi.nlm.nih.gov

Benefits of exercise training in the treatment of heart failure: study with a control group. [2022]