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

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

Conditions

Fontan Physiology, Frailty, Single Ventricle Heart Disease

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Study Overview

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Study Details

Study overview

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

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

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

Condition
Fontan Physiology
Intervention / Treatment

-

Contacts and Locations

Ann Arbor

University of Michigan, Ann Arbor, Michigan, United States, 48109

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.

For general information about clinical research, read Learn About Studies.

Eligibility 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.

Ages Eligible for Study

13 Years to 18 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

University of Michigan,

Jesse Hansen, MD, PRINCIPAL_INVESTIGATOR, University of Michigan

Study Record Dates

2025-12