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| Name | Class |
|---|---|
| Children's Hospital of Nanjing Medical University | OTHER |
| Beijing Children's Hospital | OTHER |
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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Adaptive Digital Rehabilitation (JITAI-Based) Group | Experimental | Participants will receive the JITAI-based adaptive digital exercise rehabilitation program supported by wearable monitoring devices and the digital rehabilitation platform. |
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| Standard Rehabilitation Care Group | Active Comparator | Participants will receive standard postoperative exercise rehabilitation according to current clinical guidelines, without adaptive digital adjustments. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| JITAI-Based Digital Exercise Rehabilitation Program | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Six-Minute Walk Distance (6MWD) | 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. | Baseline to post-intervention (approximately 7-10 days postoperative period) |
| Cardiac Function Parameters (LVEF, FS) | 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. | Baseline to Post-intervention (within 7-10 days after surgery) |
| Lower Extremity Muscle Strength | 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. | Baseline to Post-intervention (within 7-10 days after surgery) |
| Measure | Description | Time Frame |
|---|---|---|
| Training Adherence Rate | Percentage of prescribed training sessions completed by participants. Higher percentage indicates better adherence. | Assessed at discharge |
| Change in Exercise Fear (TSK-C Score) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| hua ji Zhu | Contact | +86 13588326715 | jihuazhu@zju.edu.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zhejiang University School of Medicine Children's Hospital | Hangzhou | Zhejiang | 31000 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30590757 | Result | Gonul S, Namli T, Huisman S, Laleci Erturkmen GB, Toroslu IH, Cosar A. An expandable approach for design and personalization of digital, just-in-time adaptive interventions. J Am Med Inform Assoc. 2019 Mar 1;26(3):198-210. doi: 10.1093/jamia/ocy160. | |
| 27663578 | Result | Nahum-Shani I, Smith SN, Spring BJ, Collins LM, Witkiewitz K, Tewari A, Murphy SA. Just-in-Time Adaptive Interventions (JITAIs) in Mobile Health: Key Components and Design Principles for Ongoing Health Behavior Support. Ann Behav Med. 2018 May 18;52(6):446-462. doi: 10.1007/s12160-016-9830-8. |
| Label | URL |
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| Related Info | View source |
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| Standard Exercise Rehabilitation Program | Behavioral | 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. |
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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.
| From baseline to 4 weeks after the intervention |
| Exercise enjoyment score | 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. | Within 24 hours after completion of the intervention |
| Incidence, number, and type of exercise-training safety events | 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. | From baseline (first exercise training session) through hospital discharge, up to [30 days]. |
| ID | Term |
|---|---|
| D006330 | Heart Defects, Congenital |
| ID | Term |
|---|---|
| D018376 | Cardiovascular Abnormalities |
| D002318 | Cardiovascular Diseases |
| D006331 | Heart Diseases |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
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