ACTIVE_NOT_RECRUITING

WE BEAT - HEART Club Fontan Wellness Project: A Virtual Resilience Promotion and Frailty Prevention Program

Conditions

Fontan Physiology Frailty Single Ventricle Heart Disease Wellness education Exercise program

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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

This trial is being conducted to evaluate the effect of a small-group wellness education program combined with a longitudinal, individualized prescription exercise program on the wellness, resiliency, and daily activity levels of pediatric patients with Fontan physiology. There will be two phases for this project. The first phase is the "WE BEAT Group Wellness Education Program" and participants will be transitioned into the phase two HEART Club following phase one. The trial will look at feasibility and acceptability of the program. Additional hypothesis include home whether exercise interventions can: * be delivered without any associated serious cardiac events; * will result in a decreased proportion of patients who are categorized as frail when compared to the cohort's pre-test baseline. * will result in increased measured peak oxygen consumption when compared with their pre-intervention baseline. * will result in increased step counts measured monthly from baseline to end of intervention * will improve self-reported quality of life from baseline to post-intervention. * will result in increased patient reported activity level from baseline to post-intervention

Official Title

WE BEAT - HEART Club Fontan Wellness Project: A Virtual Resilience Promotion and Frailty Prevention Program

Quick Facts

Study Start:2022-03-30

Study Completion:2026-07

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:ACTIVE_NOT_RECRUITING

Study ID

NCT05199857

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:13 Years to 18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:CHILD, ADULT

Inclusion Criteria	Exclusion Criteria
* Males and females with Fontan physiology who are 13 to \<19 years of age at enrollment * Own a mobile device capable of installing the University of Michigan Patient Portal application * Fluent in English * Participant consent or parental/guardian consent and participant assent	* Height \< 130 centimeters * 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, developmental, and/or social disorder that would prevent successful completion of planned study testing or would invalidate its results. * Suicidality or homicidality in the past 6 months.

Inclusion Criteria

Exclusion Criteria

* Males and females with Fontan physiology who are 13 to \<19 years of age at enrollment
* Own a mobile device capable of installing the University of Michigan Patient Portal application
* Fluent in English
* Participant consent or parental/guardian consent and participant assent

* Height \< 130 centimeters
* 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, developmental, and/or social disorder that would prevent successful completion of planned study testing or would invalidate its results.
* Suicidality or homicidality in the past 6 months.

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 Date2022-03-30

Study Completion Date2026-07

Study Record Updates

Study Start Date2022-03-30

Study Completion Date2026-07

Terms related to this study

Keywords Provided by Researchers

Wellness education
Exercise program

Additional Relevant MeSH Terms

Fontan Physiology
Frailty
Single Ventricle Heart Disease