Adaptive Digital Exercise Rehabilitation for Children After CHD Surgery
5 maggio 2026 aggiornato da: The Children's Hospital of Zhejiang University School of Medicine
Development and Evaluation of a Just-in-Time Adaptive Digital Exercise Rehabilitation Program for Children After Congenital Heart Disease Surgery
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
Panoramica dello studio
Stato
Non ancora reclutamento
Tipo di studio
Interventistico
Iscrizione (Stimato)
130
Fase
- Non applicabile
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Contatto studio
- Nome: hua ji Zhu
- Numero di telefono: +86 13588326715
- Email: jihuazhu@zju.edu.cn
Luoghi di studio
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Zhejiang
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Hangzhou, Zhejiang, Cina, 31000
- Zhejiang University School of Medicine Children's Hospital
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Contatto:
- hua ji Zhu
- Numero di telefono: +86 13588326715
- Email: jihuazhu@zju.edu.cn
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Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
- Bambino
Accetta volontari sani
No
Descrizione
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
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Terapia di supporto
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Separare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
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Sperimentale: Adaptive Digital Rehabilitation (JITAI-Based) Group
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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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.
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Comparatore attivo: Standard Rehabilitation Care Group
Participants will receive standard postoperative exercise rehabilitation according to current clinical guidelines, without adaptive digital adjustments.
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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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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
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Change in Six-Minute Walk Distance (6MWD)
Lasso di tempo: Baseline to post-intervention (approximately 7-10 days postoperative period)
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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.
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Baseline to post-intervention (approximately 7-10 days postoperative period)
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Cardiac Function Parameters (LVEF, FS)
Lasso di tempo: Baseline to Post-intervention (within 7-10 days after surgery)
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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.
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Baseline to Post-intervention (within 7-10 days after surgery)
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Lower Extremity Muscle Strength
Lasso di tempo: Baseline to Post-intervention (within 7-10 days after surgery)
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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.
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Baseline to Post-intervention (within 7-10 days after surgery)
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
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Training Adherence Rate
Lasso di tempo: Assessed at discharge
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Percentage of prescribed training sessions completed by participants.
Higher percentage indicates better adherence.
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Assessed at discharge
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Change in Exercise Fear (TSK-C Score)
Lasso di tempo: From baseline to 4 weeks after 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.
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From baseline to 4 weeks after the intervention
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Exercise enjoyment score
Lasso di tempo: Within 24 hours after completion of the intervention
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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.
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Within 24 hours after completion of the intervention
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Incidence, number, and type of exercise-training safety events
Lasso di tempo: From baseline (first exercise training session) through hospital discharge, up to [30 days].
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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.
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From baseline (first exercise training session) through hospital discharge, up to [30 days].
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Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Pubblicazioni e link utili
La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.
Pubblicazioni generali
- 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.
- 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.
Collegamenti utili
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio (Stimato)
30 dicembre 2026
Completamento primario (Stimato)
30 gennaio 2029
Completamento dello studio (Stimato)
28 febbraio 2029
Date di iscrizione allo studio
Primo inviato
28 gennaio 2026
Primo inviato che soddisfa i criteri di controllo qualità
5 maggio 2026
Primo Inserito (Effettivo)
8 maggio 2026
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
8 maggio 2026
Ultimo aggiornamento inviato che soddisfa i criteri QC
5 maggio 2026
Ultimo verificato
1 dicembre 2025
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- 2026-IRB-0019
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
NO
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
No
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
No
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .