Home-Based Cardiac Rehabilitation for Heart Failure

(MOBILE HEART Trial)

Overseen By Bassim El-Sabawi, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Vanderbilt University Medical Center

Disqualifiers: Stage D heart failure, NYHA class IV, Congenital heart disease, Pregnancy, others

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

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

100 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new method for people with heart failure to conduct cardiac rehabilitation at home using a custom app and digital tools. Researchers aim to determine if this home-based program can improve physical activity, quality of life, and other health outcomes compared to usual care. Participants will be divided into two groups: one will follow standard care, while the other will use the app-based home rehabilitation program. This trial suits those with heart failure who have been hospitalized or recently visited a cardiologist and are receiving ongoing care at VUMC. As an unphased trial, this study offers participants the chance to contribute to innovative research that could transform cardiac rehabilitation.

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 study team or your doctor.

What prior data suggests that this home-based cardiac rehabilitation is safe for heart failure patients?

Research shows that home-based cardiac rehabilitation (HBCR) offers a safe option for people with heart problems. Studies have found HBCR to be as safe as traditional programs conducted at medical centers. For individuals with heart conditions like heart failure or those who have had a heart attack, HBCR can improve heart health without added risks.

A review of studies found that both HBCR and center-based programs safely support recovery and enhance health in people with heart diseases, including those who have experienced a heart attack or undergone heart procedures.

For those considering joining a trial with HBCR, evidence suggests it is a safe and well-tolerated choice. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about home-based cardiac rehabilitation for heart failure because it offers a convenient alternative to traditional, center-based programs. Unlike standard rehabilitation, which requires patients to travel to a facility, this approach uses a mobile app and video calls with an exercise physiologist, allowing patients to engage in rehabilitation from the comfort of their homes. This method not only increases accessibility for those who may have transportation difficulties or busy schedules, but it also provides personalized support and guidance tailored to the patient's progress. By incorporating technology and remote monitoring, this approach aims to improve adherence and outcomes in heart failure management.

What evidence suggests that this trial's home-based cardiac rehabilitation could be effective for heart failure?

Research has shown that cardiac rehabilitation exercises at home can be effective for people with heart failure. In this trial, participants in the home-based cardiac rehabilitation arm will use mobile health tools like apps and have periodic video calls with exercise physiologists. Studies have demonstrated that these home-based programs can increase activity levels and improve quality of life. For instance, patients with heart failure who participated in home-based rehab reported better health outcomes than those who did not. One study found that using health apps and having regular video calls with health professionals helped manage heart failure. Overall, home-based rehab offers a promising option for those unable to attend sessions in person. ^{2 3 5 6 7}

Who Is on the Research Team?

Brian R. Lindman, MD

Principal Investigator

Vanderbilt University Medical Center

Are You a Good Fit for This Trial?

This trial is for individuals with heart failure who are unable to participate in center-based cardiac rehabilitation. Participants must have access to a smartphone or tablet and be willing to use an app and digital tools as part of the intervention.

Inclusion Criteria

Randomized Controlled Trial: Willingness to continue and participate in the study visits and other study activities required for the RCT

I have heart failure, was hospitalized for it within the last year, and see a doctor at VUMC.

Exclusion Criteria

Randomized Controlled Trial: Non-adherence to wearing the Actigraph activity tracker during the roll-in phase for a minimum of 4 compliant days, unable to complete the baseline study visit within 4 weeks of the completion of the roll-in actigraphy assessment

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Roll-in

Participants undergo a brief roll-in period before randomization

1 week

Treatment

Participants receive either standard care or home-based cardiac rehabilitation using a mobile health intervention

12 weeks

Periodic video calls with exercise physiologist

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Home-Based Cardiac Rehabilitation

Trial Overview The study is testing a home-based cardiac rehabilitation (HBCR) program delivered through an app against usual care without this program. It aims to improve physical activity, quality of life, and reduce clinical events by focusing on key health behaviors.

How Is the Trial Designed?

Group I: Home-based cardiac rehabilitation mobile health intervention Experimental Treatment 1 Intervention

Home-based cardiac rehabilitation with mobile application and periodic video calls with exercise physiologist + AHA Life's Essential 8 sheets.

Group II: Control Active Control 1 Intervention

Standard of care course for an individual not participating in center based cardiac rehabilitation. AHA Life's Essential 8 Fact Sheets are provided to promote healthy living.

Home-Based Cardiac Rehabilitation is already approved in European Union, United States, Canada for the following indications:

Approved in European Union as Cardiac Rehabilitation for:

• Coronary artery disease
• Heart failure
• Post-myocardial infarction rehabilitation
• Post-percutaneous coronary intervention rehabilitation
• Post-coronary artery bypass grafting rehabilitation

Approved in United States as Cardiac Rehabilitation for:

• Coronary artery disease
• Heart failure
• Post-myocardial infarction rehabilitation
• Post-percutaneous coronary intervention rehabilitation
• Post-coronary artery bypass grafting rehabilitation

Approved in Canada as Cardiac Rehabilitation for:

• Coronary artery disease
• Heart failure
• Post-myocardial infarction rehabilitation
• Post-percutaneous coronary intervention rehabilitation
• Post-coronary artery bypass grafting rehabilitation

Who Is Running the Clinical Trial?

Vanderbilt University Medical Center

Lead Sponsor

Trials

922

Recruited

939,000+

Published Research Related to This Trial

A review of 139 randomized controlled trials involving 18,670 participants found that exercise-based cardiac rehabilitation (ExCR) significantly improves exercise capacity and health-related quality of life (HRQoL) across various delivery modes, including centre-based, home-based, and technology-enabled programs.

Centre-based ExCR specifically showed the most substantial benefits, reducing heart failure-related hospitalizations and mortality risks, highlighting its importance in managing heart failure outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of exercise-based cardiac rehabilitation delivery modes on exercise capacity and health-related quality of life in heart failure: a systematic review and network meta-analysis. Tegegne, TK., Rawstorn, JC., Nourse, RA., et al.[2022]

The Veterans Affairs home-based cardiac rehabilitation (HBCR) program showed significant improvements in various health metrics among 923 veterans, including increased exercise capacity, reduced depression, and better eating habits, with no reported safety issues.

With a completion rate of 62%, the HBCR program was well-received by participants, indicating it is an effective and safe alternative to traditional site-based cardiac rehabilitation, especially for patients with complex health needs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Home-Based Cardiac Rehabilitation: EXPERIENCE FROM THE VETERANS AFFAIRS. Drwal, KR., Wakefield, BJ., Forman, DE., et al.[2023]

Cardiac rehabilitation (CR) is effective in reducing morbidity and mortality in patients with cardiovascular disease, but participation rates in the U.S. are low, highlighting the need for new delivery methods like home-based CR (HBCR).

Evidence suggests that HBCR can achieve similar clinical outcomes to traditional center-based CR, making it a viable option for low- to moderate-risk patients who cannot attend in-person programs, though further research is needed to strengthen its evidence base for diverse patient groups.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Home-Based Cardiac Rehabilitation: A Scientific Statement From the American Association of Cardiovascular and Pulmonary Rehabilitation, the American Heart Association, and the American College of Cardiology. Thomas, RJ., Beatty, AL., Beckie, TM., et al.[2022]

Both home-based cardiac rehabilitation (HBCR) and center-based cardiac rehabilitation (CBCR) significantly improved cardiovascular risk factors such as low-density lipoprotein levels, eating habits, and psychological status in a study of 72 patients over 6 months.

While both programs enhanced exercise duration and metabolic equivalents, CBCR showed slightly better improvements, suggesting that both types of rehabilitation can effectively modify patient lifestyles, even though smoking rates increased in both groups.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Effect of Home-Based Cardiac Rehabilitation on Cardiovascular Risk Factors Management. Kim, C., Lee, SH.[2023]

Patients with heart failure (HF) who completed home-based cardiac rehabilitation (HBCR) had a significantly lower risk of all-cause mortality and hospitalizations compared to those who did not attend HBCR, with an adjusted hazard ratio of 0.32.

Both heart failure with reduced ejection fraction (HFrEF) and preserved ejection fraction (HFpEF) patients showed similar improvements in health outcomes after completing HBCR, making it a beneficial option for those unable to attend traditional center-based rehabilitation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Home Based Cardiac Rehabilitation Participation Among Patients With Heart Failure. Hammad Jafri, S., Qureshi, R., Ho, TTT., et al.[2023]

Real-time monitoring of exercise intensity, electrocardiography, and shortness of breath during home-based cardiac rehabilitation (HBCR) can effectively manage heart failure patients, especially after hospital discharge.

HBCR allows for frequent disease monitoring and timely medication adjustments, which is particularly beneficial during situations like the COVID-19 pandemic when traditional in-person visits may be limited.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Disease management using home-based cardiac rehabilitation for patients with heart failure. Miura, H., Shimada, Y., Fukui, N., et al.[2023]

Home-based cardiac rehabilitation (HBCR) is shown to have a very low incidence of adverse events, with only one severe adverse event reported among 808 participants, translating to a rate of 1 per 23,823 patient-hours of exercise.

No deaths or hospitalizations were linked to HBCR, suggesting it is a safe option for patients, including those in high-risk groups, encouraging them to engage in regular physical activity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety of home-based cardiac rehabilitation: A systematic review. Stefanakis, M., Batalik, L., Antoniou, V., et al.[2022]

A review of 11 randomized controlled trials on home-based cardiac rehabilitation (HBCR) for heart failure patients showed that most studies had medium to high alignment with the core standards set by the European Society of Cardiology and the British Association for Cardiac Prevention and Rehabilitation.

While initial assessments and rapid identification of patients were well addressed, there is a significant need for improvement in managing lifestyle risk factors and focusing on long-term outcomes in HBCR programs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Examining the effectiveness of home-based cardiac rehabilitation programs for heart failure patients with reduced ejection fraction: a critical review. Darvishzadehdaledari, S., Harrison, A., Gholami, F., et al.[2023]

Citations

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Effectiveness of home-based cardiac rehabilitation ... We found several clinical trials evaluating the effects of phase II mHealth HBCR in patients with coronary heart disease and heart failure.

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/41064565/

Effectiveness of home-based cardiac rehabilitation ... Effectiveness of home-based cardiac rehabilitation programs on health outcomes of persons with heart failure: An umbrella review · Authors.

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Rehabilitation at Home Using Mobile Health for Older ... Early Cardiac Rehabilitation and Heart Failure Recovery. JAMA Network ... Effectiveness of home-based cardiac telerehabilitation as an ...

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Association of Home‐Based Cardiac Rehabilitation With ... Cardiac rehabilitation participation rates and outcomes for patients with heart failure. J Cardiopulm Rehabil Prev. 2018;38:38–42. https ...

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Long-term effects of 3-month home-based cardiac ... Long-term effects of 3-month home-based cardiac rehabilitation using information and communication technology for heart failure with physical ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39150858/

A Dual-Modality Home-Based Cardiac Rehabilitation ... Background: Cardiac rehabilitation (CR) is a safe, effective intervention for individuals with cardiovascular disease (CVD). However, a majority ...

7. sciencedirect.com sciencedirect.com/science/article/pii/S0147956322000978

Safety of home-based cardiac rehabilitation: A systematic ... In patients with CVD (acute myocardial infarction, cardiac revascularization, or heart failure), HBCR and CBCR appear to be equally safe models for improving ...