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Behavioural Intervention

Mobile Health Exercise Regimen for Heart Valve Disease (HOMERUNHITTER Trial)

N/A

Recruiting

Led By Brian R. Lindman, MD, MSc

Research Sponsored by Vanderbilt University Medical Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Treated with a transcatheter heart valve intervention (e.g., transcatheter aortic valve implantation [in the native valve or valve-in-valve], mitral transcatheter edge-to-edge repair, mitral valve-in-valve) of the aortic, mitral, or tricuspid valve done via transfemoral access

Be older than 18 years old

Must not have

Those who require a walker or who cannot get out of a chair/bed on their own and walk independently (use of a cane is acceptable)

Transcatheter heart valve intervention done via any route other than a transfemoral approach

Timeline

Screening 3 weeks

Treatment Varies

Follow Up over the entire available follow-up period for randomized participants (minimum of 6 months, maximum approximately 24-30 months).

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a home-based cardiac rehab program delivered using an app & digital tools to help improve health outcomes in those undergoing transcatheter heart valve interventions.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Since this trial involves exercise and lifestyle changes rather than medication, side effects may include typical exercise-related issues such as muscle soreness or fatigue. The specifics will depend on individual health conditions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have had a heart valve procedure without open surgery.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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

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I had a heart valve procedure not through the groin area.

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

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I had a pacemaker placed either before or after my heart valve procedure but within 6 weeks.

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I do not have any conditions like blindness or dementia that would stop me from completing study tasks.

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I am planning to join a heart rehab program at a center.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ over the entire available follow-up period for randomized participants (minimum of 6 months, maximum approximately 24-30 months).

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~over the entire available follow-up period for randomized participants (minimum of 6 months, maximum approximately 24-30 months).

This trial's timeline: 3 weeks for screening, Varies for treatment, and over the entire available follow-up period for randomized participants (minimum of 6 months, maximum approximately 24-30 months). for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Probability of the hierarchical clinical event composite

Secondary study objectives

5 meter gait speed

6 minute walk distance

All-cause death

+13 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups

Experimental Treatment

Active Control

Group I: HBCR interactiveExperimental Treatment1 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-offExperimental Treatment1 Intervention

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

Group III: ControlActive Control1 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.

0 / 7Eligibility criteria met