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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
Must not have
Height < 130 centimeters
Current intravenous inotropic drugs
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing if teaching kids about health in groups and giving them custom exercise plans can help children with a special heart condition become healthier and more active.

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.
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.
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
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I am between 13 and 18 years old with Fontan physiology.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am shorter than 130 centimeters.
Select...
I am currently on IV drugs to strengthen my heart muscle.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in the Connor-Davidson Resilience Scale 10
Change in the Lurz-Wilde pediatric frailty score
Secondary study objectives
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 home exercise intervention program based on the number of adverse events (AEs) Categorized by relatedness to the intervention

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

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

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for frailty, such as small-group wellness education programs and individualized prescription exercise programs, work by enhancing physical strength, improving cardiovascular health, and boosting mental resilience. These interventions typically include aerobic and resistance training exercises, which help increase muscle mass, improve balance, and enhance overall physical function. Additionally, wellness education programs provide knowledge and strategies to manage health better, reduce stress, and promote a more active lifestyle. For frailty patients, these treatments are vital as they can significantly improve daily activity levels, reduce the risk of falls, and enhance the quality of life by fostering greater independence and resilience.

Find a Location

Who is running the clinical trial?

University of MichiganLead Sponsor
1,843 Previous Clinical Trials
6,429,747 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
~6 spots leftby Jun 2025