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Home workouts boost fitness in kids with single ventricle hearts

NCT ID NCT04195451

Symptom relief Sponsor: Stanford University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested whether a live-video-supervised exercise program could improve fitness in children and teens (ages 8-19) born with a single ventricle, a condition often treated with the Fontan procedure. Participants exercised three times a week for three months, then a maintenance phase. The goal was to see if this approach could safely boost exercise capacity, muscle strength, and overall health, potentially lowering the risk of heart failure later in life.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
live-video-supervised exercise (aerobic + resistance training)
What this could lead to
If it works, this could lead to a safe, home-based exercise program that improves fitness and muscle health in children with Fontan circulation, potentially reducing long-term heart failure risk.
What could go wrong
This is a completed trial, but it was relatively small (150 participants) and focused on short-term fitness gains. It may not prove that exercise reduces death or need for transplant, and results may not apply to all Fontan patients.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

150 people

The number who actually took part.

Started

Aug 2020

Finished

Mar 2026

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

8 to 19 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

univentricular heart

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Single-ventricle

Contacts and locations

Locations

  • Stanford University, Lucile Packard Children Hospital

    Palo Alto, California, 94304, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.