Physical Rehabilitation for Heart Failure

(REHAB-HFpEF Trial)

Overseen By Michael B Nelson, MS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Wake Forest University Health Sciences

Must be taking: Diuretics, Vasodilators

Disqualifiers: Acute myocardial infarction, Severe valvular disease, Dementia, others

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

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 3

Duration: 12 weeks

880 Participants Needed

Trial Summary

What is the purpose of this trial?

The REHAB-HFpEF trial will determine whether a novel physical rehabilitation intervention will improve the primary outcome of combined all-cause rehospitalizations and mortality and the secondary outcome of major mobility disability during 6-month follow-up in patients hospitalized for heart failure and preserved ejection fraction (HFpEF), which is nearly unique to older persons, and for which there are few treatment options.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. It seems likely that you can continue your heart failure treatments, as the trial focuses on physical rehabilitation.

What data supports the effectiveness of the treatment for heart failure?

Research shows that cardiac rehabilitation, which includes exercise and other supportive therapies, can improve physical capacity, quality of life, and reduce hospitalizations for heart failure patients. It is as effective as medical treatments in improving symptoms and can be beneficial for those not fully helped by medication alone. ^{1 2 3 4 5}

Is physical rehabilitation safe for heart failure patients?

Research shows that exercise-based rehabilitation, including cardiac rehabilitation, is generally safe for heart failure patients and can improve their exercise capacity and quality of life. Supervised settings are particularly effective in ensuring safety and providing benefits. ^{3 6 7 8 9}

How is the Physical Rehabilitation Intervention treatment for heart failure different from other treatments?

The Physical Rehabilitation Intervention for heart failure is unique because it combines exercise training with lifestyle changes and psychological support, aiming to improve physical capacity and quality of life. Unlike standard drug treatments, it focuses on enhancing muscle and heart function through tailored exercise programs, which can be as effective as medication in improving symptoms and reducing hospitalizations. ^{1 3 4 5 10}

Research Team

Dalane W. Kitzman, MD

Principal Investigator

Wake Forest University Health Sciences

Eligibility Criteria

This trial is for older individuals (60+) with heart failure where the heart still pumps well but symptoms like shortness of breath or fatigue have worsened. They must be hospitalized for these issues, able to walk, and not on regular intense exercise programs. Exclusions include recent heart attacks, severe valve disease, certain cardiomyopathies, terminal illnesses other than heart failure, severe kidney disease, dementia without support or very low cognitive scores.

Inclusion Criteria

I am 60 years old or older.

My heart failure is the main reason for my symptoms.

I show at least 2 signs of heart failure, such as swelling, rapid weight gain, or breathing issues.

Exclusion Criteria

I do not have a terminal illness with a life expectancy of less than 1 year.

I have a specific heart condition like pericardial constriction, genetic hypertrophic cardiomyopathy, or amyloidosis.

You have documented dementia, or you score below a certain number on a cognitive assessment test and lack social support.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a novel, progressive, multi-domain rehabilitation and exercise training intervention, including strength, balance, endurance, and mobility training, tailored based on participant performance. The intervention begins during hospitalization and continues 3 times per week in an outpatient setting for 12 weeks.

12 weeks

3 visits per week (outpatient)

Follow-up

Participants are monitored for safety and effectiveness after treatment, with a focus on all-cause rehospitalizations, mortality, and major mobility disability over a 6-month period.

6 months

Treatment Details

Interventions

• Rehabilitation Intervention

Trial Overview The study tests a new physical rehabilitation program aimed at reducing hospital readmissions and mortality in older patients with acute decompensated heart failure who maintain good ejection fraction. It also looks at preventing major mobility disabilities over a six-month period after hospitalization.

Participant Groups

Group I: Rehabilitation Intervention Experimental Treatment 1 Intervention

The Rehabilitation Intervention is a novel, progressive, multi-domain rehabilitation and exercise training intervention. The intervention will include strength, balance, endurance, and mobility training and the specific training exercises will be tailored based on participant performance in each of these domains. The intervention will begin as soon as possible after randomization during the hospitalization and will continue 3 times per week in an outpatient setting for 12 weeks.

Group II: Attention Control Active Control 1 Intervention

Attention control participants are contacted bi-weekly by study staff to maintain contact, collect information regarding health status, clinical events, and physical activity/exercise, and ensure retention; they do not receive any specific exercise recommendations.

Rehabilitation Intervention is already approved in United States for the following indications:

Approved in United States as Physical Rehabilitation Intervention for:

• Heart failure with preserved ejection fraction (HFpEF)

Who Is Running the Clinical Trial?

Wake Forest University Health Sciences

Lead Sponsor

Trials

1,432

Recruited

2,506,000+

National Institute on Aging (NIA)

Collaborator

Trials

1,841

Recruited

28,150,000+

Findings from Research

Cardiac rehabilitation, which includes exercise training and various therapeutic adaptations, is crucial for patients with chronic heart failure and has been shown to improve functional capacity and reduce symptoms.

The program not only enhances physical health but also lowers cardiac morbidity and mortality by improving muscle function, endothelial health, and reducing sympathetic tone, which can help prevent arrhythmias.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Role of rehabilitation in the treatment of chronic heart insufficiency]. Iliou, MC.[2019]

A study involving 200 heart failure patients demonstrated that inpatient rehabilitation significantly improved symptoms, as indicated by better NYHA classifications, and had a low overall mortality rate, with only 4% of patients dying within 12 months after rehabilitation.

The study highlights the effectiveness of multimodal rehabilitation programs in enhancing the quality of life and prognosis for heart failure patients, emphasizing the importance of such interventions following acute events or chronic deterioration.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patients with Heart Failure During and After Inpatient Cardiac Rehabilitation. Schürmann, J., Noack, F., Bethge, S., et al.[2022]

Multidisciplinary disease-management programs, including cardiac rehabilitation, are essential for elderly patients with heart failure, as they help manage multiple co-morbidities and reduce the risk of hospitalization.

Inpatient cardiac rehabilitation shortly after hospitalization for acute heart failure is particularly beneficial, serving as a transition care service that enhances exercise capacity and overall health in vulnerable elderly patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Role and efficacy of cardiac rehabilitation in patients with heart failure. La Rovere, MT., Traversi, E.[2019]

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]

Cardiac rehabilitation significantly benefits heart failure patients by enhancing their physical capacity and quality of life, while also reducing comorbidities and hospitalizations.

Physiotherapy plays a crucial role in cardiac rehabilitation, providing structured and multidisciplinary care that can be delivered both on an outpatient basis and during hospital stays.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Cardiac rehabilitation for heart failure patients]. Agard, O., Cristobal, L., Caffray, M.[2013]

Exercise training is safe and beneficial for patients with heart failure, improving functional capacity, quality of life, and even survival rates, as shown in various studies.

Supervised exercise programs, particularly in cardiac rehabilitation settings, yield the best outcomes due to personalized exercise prescriptions and comprehensive management of patients' health needs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cardiac rehabilitation: a comprehensive program for the management of heart failure. Boudreau, M., Genovese, J.[2019]

Regular exercise training is highly recommended for heart failure patients, supported by strong evidence, yet many patients remain inactive due to various barriers.

Home telerehabilitation is proposed as an effective solution to encourage physical activity among heart failure patients, addressing the limitations of traditional outpatient rehabilitation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

How to do: telerehabilitation in heart failure patients. Piotrowicz, E.[2019]

Exercise-based rehabilitation for heart failure does not significantly affect short-term mortality rates but does reduce hospital admissions and improves health-related quality of life, as shown in a systematic review of 33 trials involving 4740 participants.

There is a trend suggesting that exercise may lower mortality rates in the long term (over one year), and the benefits of exercise training appear consistent across different patient characteristics, including age and severity of heart failure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exercise-based rehabilitation for heart failure. Taylor, RS., Sagar, VA., Davies, EJ., et al.[2023]

A novel high-intensity interval-training rehabilitation program for four patients with chronic heart failure (CHF) led to significant improvements in aerobic capacity and walking distance over 16 weeks, with increases of up to 52% in aerobic capacity and notable improvements in the 6-minute walk test.

No adverse events were reported during the program, suggesting that this rehabilitation approach is safe for patients with CHF, although further randomized clinical trials are needed to confirm its efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Group-based aerobic interval training in patients with chronic heart failure: Norwegian Ullevaal Model. Nilsson, BB., Hellesnes, B., Westheim, A., et al.[2015]

Physical activity is crucial for improving the health and quality of life of heart failure patients, and is strongly recommended by the European Society of Cardiology, yet only 10% of patients participate in cardiac rehabilitation after hospitalization.

The paper highlights the need to address barriers to accessing cardiac rehabilitation and suggests strategies to promote long-term physical activity adherence among heart failure patients, as the benefits of exercise diminish quickly without ongoing activity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Physical activity for patients with heart failure: Position paper from the heart failure (GICC) and cardiac rehabilitation (GERS-P) Working Groups of the French Society of Cardiology. Zores, F., Iliou, MC., Gellen, B., et al.[2020]

References

1. France pubmed.ncbi.nlm.nih.gov

[Role of rehabilitation in the treatment of chronic heart insufficiency]. [2019]

2. New Zealand pubmed.ncbi.nlm.nih.gov

Patients with Heart Failure During and After Inpatient Cardiac Rehabilitation. [2022]

3. Italy pubmed.ncbi.nlm.nih.gov

Role and efficacy of cardiac rehabilitation in patients with heart failure. [2019]

4. France pubmed.ncbi.nlm.nih.gov

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

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

[Cardiac rehabilitation for heart failure patients]. [2013]

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

Cardiac rehabilitation: a comprehensive program for the management of heart failure. [2019]

7. Poland pubmed.ncbi.nlm.nih.gov

How to do: telerehabilitation in heart failure patients. [2019]

8. England pubmed.ncbi.nlm.nih.gov

Exercise-based rehabilitation for heart failure. [2023]

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

Group-based aerobic interval training in patients with chronic heart failure: Norwegian Ullevaal Model. [2015]

10. Netherlands pubmed.ncbi.nlm.nih.gov

Physical activity for patients with heart failure: Position paper from the heart failure (GICC) and cardiac rehabilitation (GERS-P) Working Groups of the French Society of Cardiology. [2020]