Not Yet RecruitingNot Applicable

Adaptive Digital Exercise Rehabilitation for Children After CHD Surgery

China130 participantsStarted 2026-12-30

Plain-language summary

The goal of this clinical trial is to evaluate whether a Just-in-Time Adaptive Intervention (JITAI)-based digital exercise rehabilitation program can improve postoperative recovery in children after congenital heart disease (CHD) surgery. The study will examine whether this system can: Improve cardiopulmonary endurance, cardiac function, and muscle strength Increase rehabilitation adherence and enhance training experience while reducing exercise-related fear Researchers will compare children receiving the adaptive digital exercise rehabilitation program with those receiving standard postoperative rehabilitation to determine whether the digital program provides additional clinical and behavioral benefits. Participants will: Wear non-invasive monitoring devices to collect real-time physiological data Engage in daily structured exercise rehabilitation sessions guided by the digital system Receive adaptive adjustments in exercise intensity based on real-time physiological feedback Complete questionnaires on recovery, emotional status, and rehabilitation experience

Who can participate

Age range

6 Years – 12 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Children aged 6 to 12 years * Diagnosed with congenital heart disease (CHD) and have undergone cardiac surgery * Clinically stable after transfer to the general ward, with stable circulatory, respiratory, musculoskeletal, and neurological status, and assessed by the clinician as suitable to begin active exercise rehabilitation * Able to understand and cooperate with basic exercise training requirements * Written informed consent provided by the child and the legally authorized guardian Exclusion Criteria: * Absolute contraindications to exercise rehabilitation, including uncontrolled arrhythmia, acute heart failure, hemodynamic instability, severe aortic stenosis, acute myocarditis, or acute pericarditis * Severe comorbid conditions that could interfere with rehabilitation, including severe hepatic or renal dysfunction, malignancy, or acute infection * Musculoskeletal or neuromuscular disorders that would prevent participation in or completion of the rehabilitation training

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in Six-Minute Walk Distance (6MWD)

Timeframe: Baseline to post-intervention (approximately 7-10 days postoperative period)

Cardiac Function Parameters (LVEF, FS)

Timeframe: Baseline to Post-intervention (within 7-10 days after surgery)

Lower Extremity Muscle Strength

Timeframe: Baseline to Post-intervention (within 7-10 days after surgery)

Trial details

NCT IDNCT07574463

SponsorThe Children's Hospital of Zhejiang University School of Medicine

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2029-01-30

Contact for this trial

hua ji Zhu

+86 13588326715 jihuazhu@zju.edu.cn

View on ClinicalTrials.gov More Congenital Heart Disease (CHD) trials

Plain-language summary

Who can participate

Age range

6 Years – 12 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Change in Six-Minute Walk Distance (6MWD)

Timeframe: Baseline to post-intervention (approximately 7-10 days postoperative period)

Cardiac Function Parameters (LVEF, FS)

Timeframe: Baseline to Post-intervention (within 7-10 days after surgery)

Lower Extremity Muscle Strength

Timeframe: Baseline to Post-intervention (within 7-10 days after surgery)