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 range6 Years – 12 Years

SexALL

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

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 range6 Years – 12 Years

SexALL

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)