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

NCT05199857 | Completed

• 1 other identifier: HUM00205931
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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

Frailty; Single Ventricle Heart Disease; Fontan Physiology

Keywords

Wellness education; Exercise program

Outcome Measures

Primary Outcomes (2)

• Change in the Connor-Davidson Resilience Scale 10

  This is a 10 item self-report rating scale 0 (not true at all) to 4 (true nearly all the time). The overall score range from 0 (no resilience) to 40 (high Resilience).

  baseline, 6 weeks

• Change in the Lurz-Wilde pediatric frailty score

  The Lurz-Wilde Frailty score is the sum of points scored across 5 domains of physical and mental functioning (weakness, slowness, shrinkage, exhaustion, diminished physical activity). The maximum score is 10. If a patient accumulates \> 5 points, they are considered frail. If a patient accumulates 4-5 points, they are considered pre-frail.

  baseline (prior to home exercise start), after exercise program (6 months)

Secondary Outcomes (6)

• Feasibility of the 2-phase intervention based on recruitment information - number of participants that are: approached, eligible, enrolled

  up to approximately 18 months

• Feasibility of the 2-phase intervention based on sociodemographic data including: self-reported race, ethnicity, household income, and education level of primary caregiver

  up to approximately 18 months

• Feasibility of the home exercise intervention program based on the number of adverse events (AEs) Categorized by relatedness to the intervention

  6 months

• Change in the Patient Reported Outcome Measures Information System (PROMIS) pediatric physical activity -short form 4a

  baseline (prior to home exercise start), after exercise program (6 months)

• Change in the Patient-Reported Outcomes Measurement Information System Pediatric Profile-25 2.0 (PROMIS-25)

  baseline (prior to home exercise start), after exercise program (6 months)

Study Arms (1)

Wellness education and Home exercise programs

EXPERIMENTAL

Behavioral: WE BEAT Group Wellness Education program - phase 1; Behavioral: HEART Club Home Exercise program - phase 2

Interventions

WE BEAT Group Wellness Education program - phase 1 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.

Wellness education and Home exercise programs

HEART Club Home Exercise program - phase 2 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.

Wellness education and Home exercise programs

Eligibility Criteria

• Age: 13 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Michigan: lead
• Reuben Phoenix Schostak Fontan Wellness Project Fund: collaborator

Study Sites (1)

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

MeSH Terms

Conditions

Frailty

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Jesse Hansen, MD

  University of Michigan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Pediatrics

Study Record Dates

• First Submitted: January 7, 2022
• First Posted: January 20, 2022
• Study Start: March 30, 2022
• Primary Completion: April 1, 2026
• Study Completion: July 1, 2026
• Last Updated: July 10, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)