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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

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

HOMERUNHITTER Trial 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.Check my eligibility

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.See study design

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.

HOMERUNHITTER Trial Eligibility Criteria

Inclusion Criteria

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

Select...

I have had a heart valve procedure without open surgery.

HOMERUNHITTER Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Probability of the hierarchical clinical event composite

Secondary outcome measures

5 meter gait speed

6 minute walk distance

All-cause death

+13 more

HOMERUNHITTER 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 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Vanderbilt University Medical CenterLead Sponsor

857 Previous Clinical Trials

671,818 Total Patients Enrolled

1 Trials studying Valvular Heart Disease

2,250 Patients Enrolled for Valvular Heart Disease

Piedmont HealthcareOTHER

22 Previous Clinical Trials

5,502 Total Patients Enrolled

Inova Fairfax HospitalOTHER

10 Previous Clinical Trials

7,304 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are further participants welcome to join the experiment?

"The clinicaltrials.gov repository indicates that this trial is currently in the recruitment phase, which began on October 16th 2023 and was last modified November 2nd 2023."

Answered by AI

How many participants are engaged in this trial?

"Affirmative. The information on clinicaltrials.gov indicates that the study is currently in search of participants, with an initial post date of October 16th 2023 and a recent edit on November 2nd 2023. 375 individuals are sought amongst 1 medical centre for this trial."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Home-Based Cardiac Rehabilitation Using a Novel Mobile Health Exercise Regimen Following Transcatheter Heart Valve Interventions

Brian Lindman 2023. "Home-Based Cardiac Rehabilitation Using a Novel Mobile Health Exercise Regimen Following Transcatheter Heart Valve Interventions". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06077201.

All > Aortic Stenosis > Cardiology