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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new physical rehab program to determine if it can reduce hospital visits and improve mobility in people with heart failure with preserved ejection fraction (HFpEF), a condition mainly affecting older adults. The rehab includes exercises for strength, balance, endurance, and mobility, tailored to each individual, and occurs three times a week for 12 weeks. Participants will either receive this exercise program or have regular check-ins without specific exercise advice. The trial seeks participants who have been hospitalized for heart failure treatment and can walk short distances independently, even with a walking aid. As an unphased trial, this study offers a unique opportunity to contribute to research that could enhance the quality of life for those with HFpEF.

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 prior data suggests that this rehabilitation intervention is safe for heart failure patients?

Research has shown that a similar rehabilitation program has been tested in older patients with sudden heart failure. In these studies, participants received the program well, and it improved their physical abilities and quality of life. No major negative side effects were reported. Patients became stronger, improved their balance, and moved more easily without serious issues. This suggests that the rehabilitation treatment in the current trial is likely safe for participants, especially since it is customized to meet individual needs. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike standard heart failure treatments that typically focus on medication and lifestyle changes, the Rehabilitation Intervention offers a comprehensive, personalized exercise program. This innovative approach combines strength, balance, endurance, and mobility training tailored to each participant's capabilities. Researchers are excited about this method because it begins during hospitalization and continues consistently for 12 weeks, potentially enhancing recovery and quality of life beyond what current options provide.

What evidence suggests that this rehabilitation intervention is effective for heart failure?

Research shows that a personalized physical rehab program can benefit older adults with heart failure with preserved ejection fraction (HFpEF). Studies have found that these programs improve physical abilities, reduce frailty, and enhance quality of life. For example, the REHAB-HF trial discovered that a rehab program focusing on strength, balance, endurance, and mobility improved physical function and lowered the chances of hospital readmission. Another study found that frail patients who started rehab early experienced better health outcomes. In this trial, participants will either receive a Rehabilitation Intervention, which includes tailored exercises for strength, balance, endurance, and mobility, or join an Attention Control group that does not receive specific exercise recommendations. Overall, this evidence suggests that a well-structured rehab program can significantly aid recovery and improve well-being in patients with HFpEF. ^{2 3 6 7 8}

Who Is on the Research Team?

Dalane W. Kitzman, MD

Principal Investigator

Wake Forest University Health Sciences

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

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]

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]

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]

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]

Citations

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pubmed.ncbi.nlm.nih.gov

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Relationship of Race With Functional and Clinical Outcomes ...

Conclusions The intervention produced similarly large improvements in physical function and health-related quality of life in both older Black ...

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jamanetwork.com

jamanetwork.com/journals/jamacardiology/fullarticle/2799721

Frailty and Effects of a Multidomain Physical Rehabilitation ...

These findings suggest that frail patients with ADHF may derive greater benefit from early physical rehabilitation intervention.

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Physical Rehabilitation for Older Patients Hospitalized for ...

The REHAB-HF trial examined the effects of an early, transitional, tailored, progressive rehabilitation intervention that included multiple physical-function ...

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jacc.org/doi/10.1016/j.jchf.2021.05.007

Rehabilitation Intervention in Older Patients With Acute ...

The REHAB-HF trial showed that an early multidomain rehabilitation intervention improved physical function, frailty, quality-of-life, and depression in older ...

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rethinkingclinicaltrials.org

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Multi-Domain Rehabilitation for Older Patients With ...

The research team found that the multi-domain cardiac rehabilitation program reduced CV death or CV-related, unplanned hospitalization in their ...

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Rehabilitation Intervention in Older Patients with Acute Heart ...

The REHAB-HF trial showed that an early, multi-domain rehabilitation intervention improved physical function, frailty, quality-of-life, and depression in older ...

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ahajournals.org/doi/10.1161/JAHA.123.030588

Relationship of Race With Functional and Clinical ...

The REHAB‐HF (Rehabilitation Therapy in Older Acute Heart Failure Patients) trial demonstrated that a transitional, tailored, progressive ...

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Physical Rehabilitation for Older Patients With Acute Heart ...

The REHAB-HFpEF trial will determine whether a novel physical rehabilitation intervention will improve the primary outcome of combined all-cause ...