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Tailored activity plans could boost heart health in kids with congenital heart disease

NCT ID NCT06945003

Disease control Sponsor: University of Ulster 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 trial tests whether a personalized physical activity plan can help children aged 5–18 with congenital heart disease increase their exercise capacity and daily activity levels. The plan is designed with input from parents, teachers, and a pediatric cardiologist to address safety concerns. Participants follow the plan at home for 12 weeks, with follow-ups at 3 and 6 months. The goal is to improve heart and lung function and help more children meet recommended physical activity guidelines.

What this could mean

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

Active substance
individualized physical activity plan (SHAPE)
What this could lead to
If effective, this plan could help children with congenital heart disease safely increase their exercise capacity and meet recommended physical activity guidelines, improving their heart health and quality of life.
What could go wrong
This is a small, early-stage trial with 60 participants, so results may not apply to all children with congenital heart disease. The plan relies on family and school cooperation, which may vary.

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

60 people

The number who actually took part.

Started

May 2025

Finished

Apr 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

5 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: * Children with congenital heart disease aged 5-18 years (all diagnoses). * Children with congenital heart disease aged 5-18 years and an intellectual disability. Exclusion Criteria: * Children or parents/guardians who do not wish to give assent or consent to participate in this study. * Children with an underlying health condition and or physical disability in addition to congenital heart disease, to minimize the risk of confounding variables.

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Conditions

The condition(s) this trial relates to.

congenital heart disease Motor Activity

As listed by the trial registrant

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

Congenital heart disease

Contacts and locations

Locations

  • Royal Belfast Hospital for Sick Children

    Belfast, United Kingdom

More trials for these conditions

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