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Home workouts could boost heart health for congenital heart patients

NCT ID NCT06771687

Symptom relief Sponsor: Erasmus Medical Center Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 tests whether a 12-week home-based high intensity interval training program can improve exercise capacity in people aged 12 to 45 with a congenital heart defect that required a surgical connection between the right ventricle and pulmonary artery. Participants are randomly assigned to either start the program immediately or after a waiting period. The study measures changes in peak oxygen consumption, heart function, and quality of life.

What this could mean

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

Active substance
high intensity interval training (exercise program)
What this could lead to
If it works, this could offer a safe, home-based exercise program to improve fitness and quality of life for people with certain congenital heart defects.
What could go wrong
This is a small, early-stage trial with only 38 participants. The exercise program may not improve exercise capacity for everyone, and results may not apply to all patients with similar conditions.

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

About 38 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jan 2025

Expected to finish

Oct 2028

An estimate. End dates often move.

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

12 to 45 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: 1. Congenital absence of an unobstructed connection between the right ventricle and pulmonary artery, requiring surgical implantation of a right ventricle to pulmonary artery conduit, including patients with: 1. Truncus arteriosus 2. Pulmonary atresia with ventricular septum defect 3. Severe tetralogy of Fallot 4. Other forms of pulmonary atresia with biventricular correction 2. Age 12 to 45 years. 3. Current follow-up in Academic Center for Congenital Heart Disease (ACAHA; Erasmus MC Rotterdam and Radboudumc Nijmegen). 4. Signed informed consent. Exclusion Criteria: 1. Ventricular arrhythmias and/or channelopathy. 2. Implantable cardioverter defibrillator implantation due to inherited arrhythmia syndromes. 3. Left ventricular ejection fraction and/or right ventricular ejection fraction less than 30 percent. 4. Elite athletes (i.e. national team, Olympians, professional athletes, exercising equal to or more than 10 h/week, according to definition in 2020 European Society of Cardiology Guidelines for Sports Cardiology and Exercise in Patients with Cardiovascular Disease). 5. Cardiovascular lesions requiring intervention (according to international guidelines). 6. Cardiovascular intervention (surgery or catheterization) less than 6 months ago. 7. Cardiovascular medication changes less than 3 months ago. 8. Hospitalization for treatment of cardiovascular events less than 6 months ago. 9. Comorbidities or developmental delay impeding exercise training (e.g. neuromuscular disease, symptomatic myocardial ischemia, syndromic diagnoses such as trisomy 21). 10. Inability to provide informed consent.

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Conditions

The condition(s) this trial relates to.

congenital heart disease Motor Activity persistent truncus arteriosus Pulmonary Atresia pulmonary atresia with ventricular septal defect tetralogy of fallot

As listed by the trial registrant

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

Congenital heart disease Pulmonary atresia Tetralogy of fallot Truncus arteriosus

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    2 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • ErasmusMC

    RECRUITING

    Rotterdam, South Holland, 3015 GD, Netherlands

  • Radboudumc

    NOT_YET_RECRUITING

    Nijmegen, Gelderland, 6525 GA, Netherlands

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