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

University of Michigan

Status

Active, not recruiting

Conditions

Fontan Physiology

Frailty

Single Ventricle Heart Disease

Treatments

Behavioral: HEART Club Home Exercise program - phase 2

Behavioral: WE BEAT Group Wellness Education program - phase 1

Study type

Interventional

Funder types

Other

Identifiers

NCT05199857

HUM00205931

Details and patient eligibility

About

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

Enrollment

30 estimated patients

Sex

All

Ages

13 to 18 years old

Volunteers

No Healthy Volunteers

Inclusion 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

Exclusion criteria

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.