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

Trial Summary

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 valve disease?

Research shows that home-based cardiac rehabilitation (HBCR) using smartphone interaction is effective in reducing major adverse cardiac events and improving exercise capacity in patients with coronary heart disease, suggesting potential benefits for heart valve disease patients as well. ^{1 2 3 4 5}

Is home-based cardiac rehabilitation safe for humans?

Research indicates that home-based cardiac rehabilitation (HBCR) is generally safe for patients with coronary heart disease, showing lower rates of major adverse cardiac events and unscheduled readmissions compared to usual care. ^{1 2 3 4 6}

How is the Home-Based Cardiac Rehabilitation treatment different from other treatments for heart valve disease?

Home-Based Cardiac Rehabilitation (HBCR) is unique because it allows patients to perform their cardiac rehabilitation exercises at home, often using smartphone apps for guidance and monitoring, which can improve exercise capacity and reduce cardiac risks without needing frequent hospital visits. ^{1 3 7 8 9}

What is the purpose of this trial?

The vast majority of cardiac rehabilitation eligible individuals do not participate in center based cardiac rehabilitation (CBCR). While steps to encourage participation in CBCR are important, many individuals will still not participate for a variety of reasons. This randomized controlled trial is evaluating a home-based cardiac rehabilitation (HBCR) intervention delivered using a custom app and digital tools in patients undergoing transcatheter heart valve interventions (THVIs). After a brief roll-in period, participants not intending to participate in CBCR are randomized to one of three groups: (1) control, (2) HBCR mobile health intervention with hands-off delivery, and (3) HBCR mobile health intervention with interactive delivery. Participants in the intervention groups (hands-off/interactive delivery) will also be randomized to continue the intervention for 12 weeks or 24 weeks. The intervention targets key health behaviors and includes traditional cardiac rehabilitation components. The study will assess the effect of the intervention on clinical events, physical activity, quality of life, and other outcomes. Those who intend to participate in CBCR will be followed in a registry.

Research Team

Brian R. Lindman, MD

Principal Investigator

Vanderbilt University Medical Center

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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 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]

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 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]

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

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

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

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

3. Switzerland pubmed.ncbi.nlm.nih.gov

Chinese Home-Based Cardiac Rehabilitation Model Delivered by Smartphone Interaction Improves Clinical Outcomes in Patients With Coronary Heart Disease. [2021]

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

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

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

Home-Based Cardiac Rehabilitation Among Patients Unwilling to Participate in Hospital-Based Programs. [2023]

6. United States 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. [2022]

7. England 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. [2019]

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

Home-based cardiac rehabilitation using information and communication technology for heart failure patients with frailty. [2022]

9. 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]