Congenital Heart Disease (CHD), Congenital Heart Disease in Children
Conditions
Keywords
Just-in-Time Adaptive Intervention
Brief 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
Interventions
BEHAVIORALJITAI-Based Digital Exercise Rehabilitation Program
This behavioral intervention uses a Just-in-Time Adaptive Intervention (JITAI)-based digital rehabilitation program to provide individualized exercise guidance for children recovering from congenital heart disease (CHD) surgery. The program integrates wearable monitoring devices with a digital rehabilitation platform to deliver real-time exercise prompts, adaptive training intensity adjustments, and continuous feedback based on physiological signals and exercise performance. During the intervention, participants receive structured postoperative exercise training that includes daily activity guidance, monitoring of heart rate and oxygen saturation, safety alerts, and automated recommendations to support adherence and optimize training effectiveness. The system aims to improve cardiopulmonary endurance, functional capacity, and recovery-related behaviors while ensuring safety through real-time monitoring and adaptive adjustments.
BEHAVIORALStandard Exercise Rehabilitation Program
A conventional post-operative exercise rehabilitation program based on existing pediatric cardiac rehabilitation guidelines. The program includes routine breathing training, early mobilization, and graded activity exercises supervised by clinical staff. No adaptive algorithm or real-time system-driven adjustments are used. Wearable devices may be used for data collection only, without influencing the intervention.
Sponsors
The Children's Hospital of Zhejiang University School of Medicine
Children's Hospital of Nanjing Medical University
Beijing Children's Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
6 Years to 12 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Six-Minute Walk Distance (6MWD) | Baseline to post-intervention (approximately 7-10 days postoperative period) | Six-minute walk distance will be measured to assess changes in functional exercise capacity in children after congenital heart disease surgery. The outcome will compare the improvement in 6MWD between the adaptive digital rehabilitation group and the usual care group. |
| Cardiac Function Parameters (LVEF, FS) | Baseline to Post-intervention (within 7-10 days after surgery) | Left ventricular ejection fraction (LVEF) assessed via echocardiography to evaluate changes in cardiac function following rehabilitation. Higher values indicate better cardiac performance. Measurements will be compared across study arms. |
| Lower Extremity Muscle Strength | Baseline to Post-intervention (within 7-10 days after surgery) | Assessment of lower-limb muscle strength using standardized pediatric strength testing (e.g., manual muscle testing or dynamometer as applicable). Measures reflect postoperative physical recovery and response to the adaptive rehabilitation intervention. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Training Adherence Rate | Assessed at discharge | Percentage of prescribed training sessions completed by participants. Higher percentage indicates better adherence. |
| Change in Exercise Fear (TSK-C Score) | From baseline to 4 weeks after the intervention | Change in fear of movement/exercise measured using the Tampa Scale for Kinesiophobia for Children (TSK-C). Total scores range from 11 to 44, with higher scores indicating worse kinesiophobia (greater fear of movement/exercise) and lower scores indicating improvement. |
| Exercise enjoyment score | Within 24 hours after completion of the intervention | Participant-reported exercise enjoyment measured using a child-appropriate version of the Physical Activity Enjoyment Scale (PACES). Total scores range from 16 to 80, with higher scores indicating greater enjoyment and a more positive exercise experience. |
| Incidence, number, and type of exercise-training safety events | From baseline (first exercise training session) through hospital discharge, up to [30 days]. | Incidence, number, and type of safety events occurring during exercise training, including abnormal heart rate, oxygen desaturation, unstable blood pressure, or early termination of treatment due to prespecified safety criteria. |
Countries
China
Contacts
CONTACThua ji Zhu
Outcome results
None listed