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Exercise may sharpen young minds after heart surgery

NCT ID NCT02542683

What the study statuses mean

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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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 looks at whether a structured physical activity program can improve thinking and learning in children who had heart surgery. Researchers will compare these children to those having other surgeries and healthy kids. The goal is to see if exercise helps with memory, attention, and behavior over 6 to 12 months.

What this could mean

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

Active substance
structured physical activity program
What this could lead to
If successful, this could show that a simple exercise program helps children recover thinking and learning abilities after heart surgery.
What could go wrong
This is an early-stage study with no guarantee that exercise will improve cognition. Results may not apply to all children with heart 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.

Participants

About 300 people

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

Start date

Apr 2016

Expected to finish

Dec 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.

Who is studied

Physicians or nurse practitioner who are providers of care for CHD patients from the pediatric cardiology and/or cardiothoracic surgical services will make initial contact with parents of potential study subjects regarding enrollment in the study.

Ages

30 months to 6 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

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: * Congenital Heart Diseases (CHD) Cohort: All children with congenital cyanotic cardiac diseases scheduled for congenital cardiac surgery who are older than 30 months of age. * Non-CHD, Surgical Cohort: All children 30 months or older who are undergoing non-cardiac surgery at Columbia University Medical Center (CUMC), including pediatric general surgery, urological surgery, ear, nose and throat (ENT) surgery, plastic surgery and eye surgery. These children will be recruited before surgery. * Non-surgical cohort: 1. Sibling of children of CHD patients within 12 months in age, and 30 months of age or older. 2. Relatives of CHD patients of the same gender within 12 months in age and 30 months of age or older. 3. Best buddies of CHD children within 12 months in age and 30 months of age or older. 4. Children who are matched by age ±6 months who are 30 months of age or older, gender, level parental education and language spoken at home Exclusion Criteria: 1. Children with known chromosomal syndromes, or known syndromes including but not limited to DiGeorge, Trisomy 21, WIlliams, Noonan and Turner. 2. Children with known physical disabilities. 3. Children with known history of central nervous system (CNS) injury including stroke, birth asphyxia, seizure disorder, intraventricular hemorrhage. 4. Children with abnormal neurological exam by a pediatric physician or nurse practitioner, and confirmed by a pediatric neurologist. 5. Children with tricuspid regurgitation on echocardiography or on cardiac angiography that is moderate or greater. 6. Children with moderate or greater decrease in ventricular function on echocardiography or on cardiac angiography. 7. Children with baseline room air oxygen saturation below 80%. 8. Children who are treated for dysrhythmias or are pacemaker-dependent. 9. Children with history of prematurity. (Non-surgical cohort) 10. Children with history of more than one episode of hospitalization. (Non-surgical cohort)

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

How to take part

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

  1. The places running it

    1 site. 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

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Contacts and locations

Locations

  • Columbia University Irving Medical Center / NewYork-Presbyterian Hospital

    RECRUITING

    New York, New York, 10032, United States

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