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

Trial Summary

What is the purpose of this trial?

The vast majority of individuals with heart failure do not participate in center based cardiac rehabilitation (CBCR). While steps to increase utilization of CBCR are important, many individuals will still not participate for a variety of reasons. This pilot randomized controlled trial is evaluating a home-based cardiac rehabilitation (HBCR) intervention delivered using a custom app and digital tools in patients with heart failure. After a brief roll-in period, participants are randomized to one of two groups: (1) control or (2) HBCR mobile health intervention. The intervention targets key health behaviors and includes traditional cardiac rehabilitation components. The study will assess the effect of the intervention on physical activity, quality of life, clinical events, and other outcomes.

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 data supports the effectiveness of the treatment Home-Based Cardiac Rehabilitation for Heart Failure?

Home-Based Cardiac Rehabilitation (HBCR) has been shown to be beneficial for patients with cardiovascular disease, and studies suggest it can manage cardiovascular risk factors effectively. While specific outcomes for heart failure patients are not fully known, HBCR has been successfully used in other countries and may offer similar benefits to traditional center-based programs. ^{1 2 3 4 5}

Is home-based cardiac rehabilitation safe for humans?

The safety of home-based cardiac rehabilitation (HBCR) is not well-documented, but it is considered a reasonable option for clinically stable low- to moderate-risk patients who cannot attend traditional programs. More research is needed to fully understand its safety across different patient groups. ^{1 3 4 5 6}

How is the home-based cardiac rehabilitation treatment different from other treatments for heart failure?

Home-based cardiac rehabilitation (HBCR) is unique because it allows patients to participate in rehabilitation from their own homes, which can increase participation rates compared to traditional center-based programs. It also offers real-time monitoring of exercise and health status, which can help manage heart failure more effectively, especially during times when in-person visits are challenging, like during the COVID-19 pandemic. ^{1 4 5 7 8}

Research Team

Brian R. Lindman, MD

Principal Investigator

Vanderbilt University Medical Center

Eligibility Criteria

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

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

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

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

References

1. Netherlands pubmed.ncbi.nlm.nih.gov

Home Based Cardiac Rehabilitation Participation Among Patients With Heart Failure. [2023]

2. Korea (South) pubmed.ncbi.nlm.nih.gov

The Effect of Home-Based Cardiac Rehabilitation on Cardiovascular Risk Factors Management. [2023]

3. United States 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. [2022]

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

Home-Based Cardiac Rehabilitation: EXPERIENCE FROM THE VETERANS AFFAIRS. [2023]

5. Japan pubmed.ncbi.nlm.nih.gov

Disease management using home-based cardiac rehabilitation for patients with heart failure. [2023]

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

Safety of home-based cardiac rehabilitation: A systematic review. [2022]

7. England 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. [2023]

8. England 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. [2022]