← Back to Search

Wellness & Exercise Program for Single Ventricle Heart Disease

N/A
Recruiting
Led By Jesse Hansen, MD
Research Sponsored by University of Michigan
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Males and females with Fontan physiology who are 13 to <19 years of age at enrollment
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to approximately 18 months
Awards & highlights

Study Summary

This trial is designed to see if a wellness and exercise program can improve the health of kids with a heart condition called Fontan physiology. The trial will be conducted in two phases and will look at feasibility, safety, and whether the program leads to improvements in areas like quality of life, fitness, and step counts.

Who is the study for?
This trial is for young people aged 13 to <19 with Fontan physiology, a type of heart condition. They must be able to give consent or have it from a guardian, own a mobile device compatible with the study's app, and speak English fluently. Those with severe heart issues, recent suicidality or homicidality, certain height restrictions, IV drug use for heart failure, exercise-induced arrhythmias, inability to complete baseline exercise tests or other conditions that could interfere are excluded.Check my eligibility
What is being tested?
The trial evaluates a two-phase program on wellness in pediatric patients with Fontan physiology. Phase one involves group wellness education (WE BEAT), followed by an individualized home exercise regimen (HEART Club). It aims to see if these interventions can safely improve frailty status, oxygen consumption during peak activity levels, daily step counts and overall quality of life without causing serious cardiac events.See study design
What are the potential side effects?
While specific side effects aren't listed due to the non-pharmaceutical nature of this intervention (education and exercise), potential risks may include typical exercise-related issues such as muscle soreness or strain. Serious cardiac events will be monitored as part of the study's safety measures.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am between 13 and 18 years old with Fontan physiology.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to approximately 18 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to approximately 18 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in the Connor-Davidson Resilience Scale 10
Change in the Lurz-Wilde pediatric frailty score
Secondary outcome measures
Change in the Patient Reported Outcome Measures Information System (PROMIS) pediatric physical activity -short form 4a
Change in the Patient-Reported Outcomes Measurement Information System Pediatric Profile-25 2.0 (PROMIS-25)
Feasibility of the 2-phase intervention based on recruitment information - number of participants that are: approached, eligible, enrolled
+3 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: Wellness education and Home exercise programsExperimental Treatment2 Interventions

Find a Location

Who is running the clinical trial?

University of MichiganLead Sponsor
1,786 Previous Clinical Trials
6,365,492 Total Patients Enrolled
3 Trials studying Frailty
103 Patients Enrolled for Frailty
Reuben Phoenix Schostak Fontan Wellness Project FundUNKNOWN
Jesse Hansen, MDPrincipal InvestigatorUniversity of Michigan
1 Previous Clinical Trials
53 Total Patients Enrolled
1 Trials studying Frailty
53 Patients Enrolled for Frailty

Media Library

HEART Club Home Exercise program - phase 2 Clinical Trial Eligibility Overview. Trial Name: NCT05199857 — N/A
Frailty Research Study Groups: Wellness education and Home exercise programs
Frailty Clinical Trial 2023: HEART Club Home Exercise program - phase 2 Highlights & Side Effects. Trial Name: NCT05199857 — N/A
HEART Club Home Exercise program - phase 2 2023 Treatment Timeline for Medical Study. Trial Name: NCT05199857 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Who is eligible to join this medical research initiative?

"This clinical trial is seeking 30 participants between the ages of 13 and 18 who have been diagnosed with frailty."

Answered by AI

How many participants are involved in the current investigation?

"Confirmatively, clinicaltrials.gov highlights that this research is presently recruiting participants. According to the initial post on March 30th 2022 and last update on March 31st 2022, this trial requires a total of 30 individuals from one location."

Answered by AI

Are recruitment efforts still underway for this clinical trial?

"The research project, which was posted on March 30th 2022 and recently amended the following day, is actively seeking participants. This information can be found via clinicaltrials.gov."

Answered by AI

Are individuals over the age of 55 being considered as participants in this research?

"Individuals aged between 13 and 18, inclusively, are qualified to sign up for this clinical trial following the set eligibility criteria."

Answered by AI
~11 spots leftby Jun 2025