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

Not Applicable

Recruiting

• Conditions: Single Ventricle Heart Disease; Fontan Physiology; Frailty
• Interventions: Behavioral: WE BEAT Group Wellness Education program - phase 1; Behavioral: HEART Club Home Exercise program - phase 2

• Registration Number: NCT05199857
• Lead Sponsor: University of Michigan

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-01-07
• Study First Submitted QC: 2022-01-07
• Study First Posted: 2022-01-20
• Study Start: 2022-03-30
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-18
• Last Update Posted: 2025-03-25
• Primary Completion: 2025-06
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Wellness education and Home exercise programs	WE BEAT Group Wellness Education program - phase 1	-
Wellness education and Home exercise programs	HEART Club Home Exercise program - phase 2	-

Primary Outcome Measures

Name	Time	Method
Change in the Connor-Davidson Resilience Scale 10	baseline, 6 weeks	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).
Change in the Lurz-Wilde pediatric frailty score	baseline (prior to home exercise start), after exercise program (6 months)	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.

Secondary Outcome Measures

Name	Time	Method
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 2-phase intervention based on recruitment information - number of participants that are: approached, eligible, enrolled	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	* Not related: Accidents and injuries not related to exercise prescription, illnesses not attributed to cardiovascular status, Cardiac events that are not temporally related to prescribed exercise sessions; * Possibly: Musculoskeletal complaints consistent with overuse or repetitive stress injury with a mechanism that is not consistent with the prescribed of exercise, Cardiac events/symptoms that occur between 90 to180 minutes after exercise; * Probably: Musculoskeletal complaints consistent with overuse or repetitive stress injury that are consistent with the prescribed mechanism of exercise, Cardiac events/symptoms that occur between 15 minutes to 90 minutes after prescribed exercise; * Definitely: Accidents or injuries that occur during prescribed exercise, Cardiac events/symptoms that occur during or up to 15 minutes after prescribed exercise
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)	This is a 4-item questionnaire that asks participants about their level of physical activity in the past 7 days. Items are scored on a 5-point scale. Scores range from 4 to 20 with 4 indicating low physical activity and 20 indicating high physical activity (better outcome).
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)	PROMIS-25 measures quality of life (i.e., depression, anxiety, and pain interference). The 25 items are on a 1-5 scale and are scored using the Health Measures Scoring Service with higher scores indicating a lower quality of life.
Seven day running average step counts	baseline (week 1 of exercise program), last week of exercise program (6 months)

Trial Locations

Locations (1)

University of Michigan; 🇺🇸 Ann Arbor, Michigan, United States