ACTIVE_NOT_RECRUITING

Home Exercise And Resiliency Training (Heart) Club

Conditions

Fontan Physiology Frailty Exercise program Liver stiffness

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Home Exercise And Resiliency Training (HEART) Club: A Virtual Care at Home Program to Reduce Frailty for Adults With Fontan Circulation

Quick Facts

Study Start:2023-03-01

Study Completion:2026-03

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:ACTIVE_NOT_RECRUITING

Study ID

NCT05543733

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:19 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

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

Inclusion Criteria

Exclusion Criteria

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

* 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

Contacts and Locations

Principal Investigator

Jesse Hansen, MD

PRINCIPAL_INVESTIGATOR

University of Michigan

Study Locations (Sites)

University of Michigan

Ann Arbor, Michigan, 48109

United States

Collaborators and Investigators

Sponsor: University of Michigan

Jesse Hansen, MD, PRINCIPAL_INVESTIGATOR, University of Michigan

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-03-01

Study Completion Date2026-03

Study Record Updates

Study Start Date2023-03-01

Study Completion Date2026-03

Terms related to this study

Keywords Provided by Researchers

Exercise program
Liver stiffness

Additional Relevant MeSH Terms

Fontan Physiology
Frailty