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

Frailty Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05199857
• Other study ID #: HUM00205931
• Status: Recruiting
• Phase: N/A
• Start date: March 30, 2022
• Est. completion date: December 2025

Study information

• Verified date: February 2024
• Source: University of Michigan
• Contact: Blake Armstrong
• Phone: 734-615-4899
• Email: blar[@]umich.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 2025
• Est. primary completion date: June 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 13 Years to 18 Years

Eligibility

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.

Related Conditions & MeSH terms

• Fontan Physiology
• Frailty
• Heart Diseases
• Single Ventricle Heart Disease
• Univentricular Heart

Intervention

Behavioral:
• 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.
• 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.

Locations

Country	Name	City	State
United States	University of Michigan	Ann Arbor	Michigan

Sponsors (2)

Lead Sponsor	Collaborator
University of Michigan	Reuben Phoenix Schostak Fontan Wellness Project Fund

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Feasibility of the 2-phase intervention based on recruitment information - number of participants that are: approached, eligible, enrolled		up to approximately 18 months
Secondary	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
Secondary	Feasibility of the home exercise intervention program based on the number of adverse events (AEs) Categorized by relatedness to the intervention	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	6 months
Secondary	Change in the Patient Reported Outcome Measures Information System (PROMIS) pediatric physical activity -short form 4a	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).	baseline (prior to home exercise start), after exercise program (6 months)
Secondary	Change in the Patient-Reported Outcomes Measurement Information System Pediatric Profile-25 2.0 (PROMIS-25)	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.	baseline (prior to home exercise start), after exercise program (6 months)
Secondary	Seven day running average step counts		baseline (week 1 of exercise program), last week of exercise program (6 months)