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

NCT ID: NCT05199857

Last Updated: 2026-01-14

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-03-30
• Study Completion Date: 2026-07-31

Brief Summary

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Wellness education and Home exercise programs

Group Type: EXPERIMENTAL

WE BEAT Group Wellness Education program - phase 1

Intervention Type: BEHAVIORAL

Participants will be assigned into a small group with 3-6 other participants and will participate in a weekly, 45-50 minute intervention session for 5 weeks, delivered by a licensed clinical psychologist or limited licensed clinical psychology fellow using University of Michigan (UM) Zoom. Each session will focus on a particular skill related to wellness and resiliency. There will also be a short battery of questionnaires to complete.

HEART Club Home Exercise program - phase 2

Intervention Type: BEHAVIORAL

This is an individualized home exercise program adapted from the exercise programs used in traditional, hospital-based cardiac rehabilitation. A complete cardiopulmonary exercise test (CPET) may be completed if needed for a baseline and one will be done at the last visit. The exercise physiology team will discuss participants exercise goals, interests, and available resources to help develop the exercise plan for the research study. Once the program is designed, participants will complete the exercise activities in the plan. Over time, participants will advance through various stages in the program and then will be gradually introduced to the principles of exercise rehabilitation and more intense physical exercise. Participants will be asked to wear a wearable activity tracker and have scheduled video check-ins with the exercise physiology team. Throughout the program participants will complete a short battery of surveys.

Interventions

WE BEAT Group Wellness Education program - phase 1

Participants will be assigned into a small group with 3-6 other participants and will participate in a weekly, 45-50 minute intervention session for 5 weeks, delivered by a licensed clinical psychologist or limited licensed clinical psychology fellow using University of Michigan (UM) Zoom. Each session will focus on a particular skill related to wellness and resiliency. There will also be a short battery of questionnaires to complete.

Intervention Type: BEHAVIORAL

HEART Club Home Exercise program - phase 2

This is an individualized home exercise program adapted from the exercise programs used in traditional, hospital-based cardiac rehabilitation. A complete cardiopulmonary exercise test (CPET) may be completed if needed for a baseline and one will be done at the last visit. The exercise physiology team will discuss participants exercise goals, interests, and available resources to help develop the exercise plan for the research study. Once the program is designed, participants will complete the exercise activities in the plan. Over time, participants will advance through various stages in the program and then will be gradually introduced to the principles of exercise rehabilitation and more intense physical exercise. Participants will be asked to wear a wearable activity tracker and have scheduled video check-ins with the exercise physiology team. Throughout the program participants will complete a short battery of surveys.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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.

• Minimum Eligible Age: 13 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Reuben Phoenix Schostak Fontan Wellness Project Fund

UNKNOWN

Sponsor Role: collaborator

University of Michigan

OTHER

Sponsor Role: lead

Responsible Party

Jesse Hansen

Assistant Professor of Pediatrics

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jesse Hansen, MD

Role: PRINCIPAL_INVESTIGATOR

University of Michigan

Locations

University of Michigan

Ann Arbor, Michigan, United States

Countries

United States

Other Identifiers

HUM00205931

Identifier Type: -

Identifier Source: org_study_id