Exercise program for children with single-ventricle hearts

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial focuses on improving the health and exercise capacity of children aged 8-19 who have undergone Fontan palliation for single-ventricle heart conditions. Participants will engage in a live-video-supervised exercise intervention aimed at enhancing muscle mass, strength, and overall cardiovascular health. The study seeks to understand the impact of structured exercise on long-term outcomes for these patients, who are at high risk for heart failure and other complications. By comparing the exercise intervention to usual care, the trial aims to provide insights into effective management strategies for this unique patient population.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 8-19 years of age
* Fontan palliation
* Ability to fast overnight
* Cardiac clearance to exercise by primary cardiologist
* Presence of an adult at home during exercise sessions for patients \<14 years old
* English-speaking patient.

Exclusion Criteria:

* NYHA Class IV (severe heart failure)
* Acute illness within the past three months
* Active protein losing enteropathy (albumin \<2.5 mg/dL)
* Implanted pacemaker
* Cognitive delay deemed severe enough to inhibit the ability to follow the exercise

Where it's running

• Stanford University, Lucile Packard Children Hospital
  Palo Alto, California, United States Recruiting

Study contacts

• Study coordinator: Seda Tierney
• Email: tierneys@stanford.edu
• Phone: 650-334-7156

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Venous Compression for Fontan Patients

  This study tests whether wearing lower-extremity compression garments can increase exercise stroke volume in people with Fontan circulation.

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• Starting Fortini after the first heart surgery to help infants with single-ventricle defects grow better

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• Fontan conduit stenting to lower liver stiffness and improve exercise capacity

  This project will see if placing a stent in an extracardiac Fontan conduit changes liver stiffness and exercise capacity in 12–21-year-olds with single-ventricle Fontan palliation.

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• Evaluating the effectiveness of SGLT2 inhibitors in adults with congenital heart disease

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  Recruiting at 11 sites Leiden University Medical Center · Baltimore, Maryland and 10 other locations · NCT06932081

• Improving fitness for adolescents with the Fontan circulation

  This study will test whether a home-based digital exercise program helps 10–17-year-olds with the Fontan circulation become more active and improve fitness compared with enhanced usual care.

  Recruiting Children's Hospital of Philadelphia · Philadelphia, Pennsylvania · NCT06918795

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.