Adaptive Digital Exercise Rehabilitation for Children After CHD Surgery
5 de mayo de 2026 actualizado por: 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
Descripción general del estudio
Estado
Aún no reclutando
Tipo de estudio
Intervencionista
Inscripción (Estimado)
130
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Estudio Contacto
- Nombre: hua ji Zhu
- Número de teléfono: +86 13588326715
- Correo electrónico: jihuazhu@zju.edu.cn
Ubicaciones de estudio
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Zhejiang
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Hangzhou, Zhejiang, Porcelana, 31000
- Zhejiang University School of Medicine Children's Hospital
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Contacto:
- hua ji Zhu
- Número de teléfono: +86 13588326715
- Correo electrónico: jihuazhu@zju.edu.cn
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Niño
Acepta Voluntarios Saludables
No
Descripción
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
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Cuidados de apoyo
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Experimental: 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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Comparador activo: 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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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Change in Six-Minute Walk Distance (6MWD)
Periodo de tiempo: 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)
Periodo de tiempo: 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
Periodo de tiempo: 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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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Training Adherence Rate
Periodo de tiempo: 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)
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Publicaciones Generales
- 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.
Enlaces Útiles
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Estimado)
30 de diciembre de 2026
Finalización primaria (Estimado)
30 de enero de 2029
Finalización del estudio (Estimado)
28 de febrero de 2029
Fechas de registro del estudio
Enviado por primera vez
28 de enero de 2026
Primero enviado que cumplió con los criterios de control de calidad
5 de mayo de 2026
Publicado por primera vez (Actual)
8 de mayo de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
8 de mayo de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
5 de mayo de 2026
Última verificación
1 de diciembre de 2025
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 2026-IRB-0019
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
NO
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
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