Home Exercise And Resiliency Training (Heart) Club

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

53 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-03-01

Study Completion Date

2026-04-30

Brief Summary

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The purpose of this research study is to evaluate the impact of a telemedicine-based structured home exercise program on frailty and exercise capacity in individuals with Fontan heart physiology, demonstrate that a telemedicine exercise program reduces socioeconomic and geographic barriers to access to exercise training, and to explore the impact of a structured exercise program on markers of Fontan-associated liver disease.

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Detailed Description

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This study will require two in-person visits to the exercise physiology lab as well as virtual follow-up visits. Visit one will require participants to complete a cardiopulmonary exercise test (CPET), liver ultrasound, 6-minute walk, grip strength test, arm circumference measure, body composition analysis, anthropometrics measurement, surveys and a biomarker blood sample collection. The second in-person visit will require participants to complete a final cardiopulmonary exercise test, liver ultrasound, 6-minute walk, grip strength test and arm circumference, biomarker blood sample and final survey.

Conditions

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Fontan Physiology Frailty

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Home exercise program

Group Type EXPERIMENTAL

Home exercise program

Intervention Type BEHAVIORAL

Participants will complete a 6-month prescription telemedicine-based structured home exercise program. Baseline information will be used to develop a personalized home exercise program. This program will involve downloading the MyDataHelps application on a mobile device to securely collect wearable device information like step counts, activity minutes, and heart rate. Additionally, participants will have multiple virtual visits as well as the 2 in-person visits.

Interventions

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Home exercise program

Participants will complete a 6-month prescription telemedicine-based structured home exercise program. Baseline information will be used to develop a personalized home exercise program. This program will involve downloading the MyDataHelps application on a mobile device to securely collect wearable device information like step counts, activity minutes, and heart rate. Additionally, participants will have multiple virtual visits as well as the 2 in-person visits.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Males and females with Fontan physiology
* 19 years old at age of enrollment

Exclusion Criteria

* Height less than 130 centimeter (cm)
* Pregnancy or the plan to become pregnant during the study period
* Current intravenous inotropic drugs
* Severe ventricular dysfunction assessed qualitatively by clinical echocardiography within six months prior to enrollment
* Severe valvar regurgitation, ventricular outflow obstruction, or aortic arch obstruction assessed by clinical echocardiography within six months prior to enrollment
* History of arrhythmia with exercise (excluding isolated supraventricular or ventricular ectopy without symptoms)
* Inability to complete exercise testing at baseline screening
* Noncardiac medical, psychiatric, and/or social disorder that would prevent successful completion of planned study testing or would invalidate its results

Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No