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Can a virtual program help teens with rare heart condition feel stronger?

NCT ID NCT05199857

Symptom relief Sponsor: University of Michigan 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jul 10, 2026 · Updated 2 times

Summary

This study tests a two-part virtual program for teens aged 13-18 with Fontan physiology, a type of single-ventricle heart disease. The first part is a small-group wellness education session each week for 5 weeks, led by a psychologist. The second part is a personalized home exercise program. Researchers want to see if the program is feasible and can improve resilience, reduce frailty, and increase daily activity. The study is small with 30 participants and is not yet recruiting.

What this could mean

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

Active substance
Wellness education and home exercise program
What this could lead to
If it works, this could offer a safe, home-based program to improve resilience and physical activity in teens with Fontan heart disease.
What could go wrong
This is a very small early study with only 30 participants and no control group. The program may not show clear benefits or be difficult to sustain at home.

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

30 people

The number who actually took part.

Started

Mar 2022

Finished

Jul 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

13 to 18 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: * 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.

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Conditions

The condition(s) this trial relates to.

Frailty univentricular cardiopathy

As listed by the trial registrant

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

Fontan physiology Frailty Single ventricle heart disease

Contacts and locations

Locations

  • University of Michigan

    Ann Arbor, Michigan, 48109, United States

More trials for these conditions

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