Clinical trial NCT05199857: WE BEAT - HEART Club Fontan Wellness Project: A Virtual Resilience Promotion and Frailty Prevention Program
Official title: WE BEAT - HEART Club Fontan Wellness Project: A Virtual Resilience Promotion and Frailty Prevention Program
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Fontan Physiology
Frailty
Single Ventricle Heart Disease
Keywords: Wellness education
Exercise program
Lead sponsor: University of Michigan
Sponsor class: OTHER
Collaborators: name: Reuben Phoenix Schostak Fontan Wellness Project Fund
First posted: 2022-01-20
Enrollment: 30
Sex: ALL
Minimum age (years): 13
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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


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.

Primary outcomes:
measure: Change in the Connor-Davidson Resilience Scale 10
timeFrame: baseline, 6 weeks
measure: Change in the Lurz-Wilde pediatric frailty score
timeFrame: baseline (prior to home exercise start), after exercise program (6 months)
Secondary outcomes:
measure: Feasibility of the 2-phase intervention based on recruitment information - number of participants that are: approached, eligible, enrolled
timeFrame: up to approximately 18 months
measure: Feasibility of the 2-phase intervention based on sociodemographic data including: self-reported race, ethnicity, household income, and education level of primary caregiver
timeFrame: up to approximately 18 months
measure: Feasibility of the home exercise intervention program based on the number of adverse events (AEs) Categorized by relatedness to the intervention
timeFrame: 6 months
measure: Change in the Patient Reported Outcome Measures Information System (PROMIS) pediatric physical activity -short form 4a
timeFrame: baseline (prior to home exercise start), after exercise program (6 months)
measure: Change in the Patient-Reported Outcomes Measurement Information System Pediatric Profile-25 2.0 (PROMIS-25)
timeFrame: baseline (prior to home exercise start), after exercise program (6 months)
measure: Seven day running average step counts
timeFrame: baseline (week 1 of exercise program), last week of exercise program (6 months)
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
Study officials:
affiliation: University of Michigan
name: Jesse Hansen, MD
role: PRINCIPAL_INVESTIGATOR
References: