Mobile Health Exercise Regimen for Heart Valve Disease

(HOMERUNHITTER Trial)

Overseen By Caleb Hayes, MPH

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Vanderbilt University Medical Center

Disqualifiers: Stroke, Pacemaker, Neuropsychiatric limitations, 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: 12-24 weeks

375 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to assist individuals who have undergone transcatheter heart valve interventions (a procedure to repair heart valves without open-heart surgery) in improving their heart health at home. It evaluates a home-based cardiac rehabilitation program using a mobile app to promote healthy behaviors and monitor progress. Participants are divided into groups to receive either a standard care guide, a hands-off app-based program, or an interactive app-based program with video support. The study examines how these methods affect physical activity, quality of life, and health outcomes. Individuals who have had a heart valve procedure through the leg and do not plan to join a traditional rehab program might be suitable candidates for this trial. As an unphased trial, this study provides a unique opportunity to explore innovative rehabilitation methods for enhanced heart health.

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 mobile health exercise regimen is safe for heart valve disease patients?

Research has shown that home-based cardiac rehabilitation (HBCR) is generally safe for people with heart conditions. Studies have found a very low risk of unwanted side effects during HBCR, allowing most people to participate in these programs at home without major issues.

Some research suggests that people who engage in HBCR may have fewer hospital visits compared to those attending center-based programs. This indicates that HBCR not only aids recovery but also promotes long-term health.

Overall, evidence supports that most patients tolerate HBCR well, which might reassure anyone considering joining a trial involving this type of home-based program. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Mobile Health Exercise Regimen for Heart Valve Disease because it offers a new way to do cardiac rehabilitation from home. Unlike traditional cardiac rehab, which often requires visits to a medical center, this approach uses a mobile app to guide patients through their exercises. The "HBCR interactive" group adds an extra layer of support with video calls from exercise physiologists, which could make rehab more personalized and engaging. Both approaches aim to make cardiac rehab more accessible and convenient, potentially leading to better outcomes for patients who can't easily access traditional rehab programs.

What evidence suggests that this trial's treatments could be effective for heart valve disease?

Research has shown that cardiac rehabilitation exercises at home can be as effective as attending a rehab center for people with heart disease. In this trial, participants will be assigned to different approaches to home-based cardiac rehabilitation (HBCR). One group will follow the HBCR hands-off approach, using a mobile application and AHA Life's Essential 8 sheets. Another group will participate in the HBCR interactive approach, which includes periodic video calls with an exercise physiologist in addition to the mobile application and AHA Life's Essential 8 sheets. Studies have found that home-based rehab can improve physical fitness and help people adhere to their exercise routines better than not doing rehab at all. Many who choose home-based rehab report greater satisfaction and are more likely to maintain their exercises. Some research even suggests that mobile apps and digital tools can enhance the effectiveness of home-based rehab. Overall, home-based rehab appears to be a good option for those who can't or don't want to attend a rehab center. ^{3 6 7 8 9}

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 heart valve disease patients who've had a transcatheter heart valve intervention via the leg. They must be able to use an activity tracker, not planning on joining center-based rehab, and capable of using digital tools without physical or mental limitations that would interfere.

Inclusion Criteria

I have had a heart valve procedure without open surgery.

Exclusion Criteria

Treating provider or site PI indicates that participation in the study would be unsafe

I had a stroke during or right after my heart valve procedure.

I can walk on my own but may use a cane.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Roll-in

Brief roll-in period before randomization

1-2 weeks

Treatment

Participants receive home-based cardiac rehabilitation using a mobile app, randomized to either hands-off or interactive delivery for 12 or 24 weeks

12-24 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

24-30 months

What Are the Treatments Tested in This Trial?

Interventions

• Home-Based Cardiac Rehabilitation

Trial Overview The study tests a home-based cardiac rehab program delivered through an app and digital tools after heart valve surgery. Participants are randomly assigned to control, hands-off mobile health intervention, or interactive mobile health intervention for either 12 or 24 weeks.

How Is the Trial Designed?

Group I: HBCR interactive 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: HBCR hands-off Experimental Treatment 1 Intervention

Home-based cardiac rehabilitation with mobile application + AHA Life's Essential 8 sheets.

Group III: 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+

Wake Forest University Health Sciences

Collaborator

Trials

1,432

Recruited

2,506,000+

Morristown Medical Center

Collaborator

Trials

3

Recruited

820+

Piedmont Healthcare

Collaborator

Trials

23

Recruited

5,700+

Inova Fairfax Hospital

Collaborator

Trials

12

Recruited

7,700+

Chattanooga-Hamilton County Hospital Authority

Collaborator

Trials

4

Recruited

640+

Medical University of South Carolina

Collaborator

Trials

994

Recruited

7,408,000+

Duke Clinical Research Institute

Collaborator

Trials

69

Recruited

242,000+

University of Michigan

Collaborator

Trials

1,891

Recruited

6,458,000+

Pinnacle Health Cardiovascular Institute

Collaborator

Trials

3

Recruited

1,500+

Published Research Related to This Trial

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]

In a study of 2556 patients from a diverse population, those who participated in home-based cardiac rehabilitation (HBCR) had lower odds of hospitalization at 12 months compared to those in center-based cardiac rehabilitation (CBCR), suggesting HBCR may be a safer option for patients.

Despite the reduced hospitalization rates, both HBCR and CBCR participants showed similar levels of medication adherence and control of cardiovascular risk factors, indicating that HBCR is effective without compromising treatment compliance.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of Home-Based vs Center-Based Cardiac Rehabilitation in Hospitalization, Medication Adherence, and Risk Factor Control Among Patients With Cardiovascular Disease. Nkonde-Price, C., Reynolds, K., Najem, M., et al.[2022]

A study involving 69 patients showed that a 6-month asynchronous home-based cardiac rehabilitation (HBCR) program significantly improved peak oxygen uptake (V̇O2peak) by 10.2%, compared to a decline of 2.7% in the control group, indicating effective enhancement of cardiorespiratory fitness.

Participants in the HBCR program exceeded their exercise goals, averaging 193.2 minutes of aerobic activity per week, demonstrating that even patients who avoid center-based rehabilitation can achieve substantial health benefits through home-based programs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Home-Based Cardiac Rehabilitation Among Patients Unwilling to Participate in Hospital-Based Programs. Nabutovsky, I., Breitner, D., Heller, A., et al.[2023]

A 12-week home-based cardiac exercise program (HBCEP) significantly improved exercise capacity, serum lipid levels, and self-efficacy in 30 coronary heart disease patients in Turkey, compared to a control group.

The improvements in health outcomes suggest that enhancing self-efficacy through educational sessions and goal-setting strategies may play a crucial role in helping patients adhere to exercise programs and reduce cardiac risk factors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of home-based cardiac exercise program on the exercise tolerance, serum lipid values and self-efficacy of coronary patients. Senuzun, F., Fadiloglu, C., Burke, LE., et al.[2019]

A comprehensive home-based cardiac rehabilitation (HBCR) program using information and communication technology (ICT) significantly improved exercise tolerance in heart failure patients with physical frailty, as evidenced by a greater increase in the 6-minute walking distance (52.1 m vs. -4.3 m in the control group; P < 0.001).

The HBCR program was safe, with no significant changes in adverse events compared to standard care, indicating that individualized ICT-based rehabilitation can effectively engage frail heart failure patients in physical activity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Home-based cardiac rehabilitation using information and communication technology for heart failure patients with frailty. Nagatomi, Y., Ide, T., Higuchi, T., 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]

The smartphone-facilitated home-based cardiac rehabilitation (HBCR) model significantly reduced major adverse cardiac events (MACE) in patients with coronary heart disease, with an incidence of 1.5% in the HBCR group compared to 8.9% in the control group over a follow-up of up to 42 months.

Patients in the HBCR group also experienced improved exercise capacity and quality of life, evidenced by higher maximal METs and better scores on the Seattle Angina Questionnaire, indicating that this model is both safe and effective for enhancing patient wellness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Chinese Home-Based Cardiac Rehabilitation Model Delivered by Smartphone Interaction Improves Clinical Outcomes in Patients With Coronary Heart Disease. Ma, J., Ge, C., Shi, Y., et al.[2021]

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]

Citations

1. thelancet.com thelancet.com/journals/landig/article/PIIS2589-7500(25)00012-3/fulltext

Effectiveness of home-based cardiac rehabilitation ... This study aims to assess the effects of mHealth HBCR interventions compared with usual care and CBCR in patients with heart disease.

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/37888805/

Home-based versus centre-based cardiac rehabilitation No evidence of a difference was seen between home- and centre-based cardiac rehabilitation in our primary outcomes up to 12 months of follow-up.

3. clinicaltrials.gov clinicaltrials.gov/study/NCT06984172

Effectiveness of Remote Cardiac Rehab After Surgery for ... The goal of this clinical trial is to learn if home-based cardiac rehabilitation using remote monitoring devices improves exercise capacity in patients ...

4. jamanetwork.com jamanetwork.com/journals/jamacardiology/fullarticle/2772381

Effectiveness of Home-Based Mobile Guided Cardiac ... 6 months of home-based mobile cardiac rehabilitation was associated with a greater increase in physical fitness compared with no cardiac rehabilitation.

5. sciencedirect.com sciencedirect.com/science/article/pii/S2772374725004454

Long-Term Outcomes of Digital Cardiac Rehabilitation Several studies suggest that patients participating in home-based cardiac rehabilitation (HBCR) report higher satisfaction, better exercise adherence, and ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10964460/

Safety and long-term outcomes of remote cardiac ... To systematically review the safety and the long-term mortality and morbidity risk-rates of the remotely-delivered cardiac rehabilitation ...

7. ahajournals.org ahajournals.org/doi/10.1161/cir.0000000000000663

Home-Based Cardiac Rehabilitation: A Scientific Statement ... CR programs reduce morbidity and mortality rates in adults with ischemic heart disease, heart failure, or cardiac surgery but are significantly ...

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

Safety of home-based cardiac rehabilitation: A systematic ... The risk of AEs during HBCR seems very low. Our results concerning the safety of HBCR should induce cardiac patients to be more active in their environment and ...

9. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2795633

Home- vs Center-Based Cardiac Rehabilitation Outcomes ... This cohort study found that participation in home-based CR was associated with fewer hospitalizations at 12 months compared with participation in center-based ...