Adaptive Digital Exercise Rehabilitation for Children After CHD Surgery
Development and Evaluation of a Just-in-Time Adaptive Digital Exercise Rehabilitation Program for Children After Congenital Heart Disease Surgery
1 other identifier
interventional
130
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Dec 2026
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 28, 2026
CompletedFirst Posted
Study publicly available on registry
May 8, 2026
CompletedStudy Start
First participant enrolled
December 30, 2026
ExpectedPrimary Completion
Last participant's last visit for primary outcome
January 30, 2029
Study Completion
Last participant's last visit for all outcomes
February 28, 2029
May 8, 2026
December 1, 2025
2.1 years
January 28, 2026
May 5, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
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)
Secondary Outcomes (4)
Training Adherence Rate
Assessed at discharge
Change in Exercise Fear (TSK-C Score)
From baseline to 4 weeks after the intervention
Exercise enjoyment score
Within 24 hours after completion of the intervention
Incidence, number, and type of exercise-training safety events
From baseline (first exercise training session) through hospital discharge, up to [30 days].
Study Arms (2)
Adaptive Digital Rehabilitation (JITAI-Based) Group
EXPERIMENTALParticipants will receive the JITAI-based adaptive digital exercise rehabilitation program supported by wearable monitoring devices and the digital rehabilitation platform.
Standard Rehabilitation Care Group
ACTIVE COMPARATORParticipants will receive standard postoperative exercise rehabilitation according to current clinical guidelines, without adaptive digital adjustments.
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Zhejiang University School of Medicine Children's Hospital
Hangzhou, Zhejiang, 31000, China
Related Publications (2)
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.
PMID: 30590757RESULTNahum-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.
PMID: 27663578RESULT
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 28, 2026
First Posted
May 8, 2026
Study Start (Estimated)
December 30, 2026
Primary Completion (Estimated)
January 30, 2029
Study Completion (Estimated)
February 28, 2029
Last Updated
May 8, 2026
Record last verified: 2025-12
Data Sharing
- IPD Sharing
- Will not share