Adaptive Digital Exercise Rehabilitation for Children After CHD Surgery

Официальное название

Development and Evaluation of a Just-in-Time Adaptive Digital Exercise Rehabilitation Program for Children After Congenital Heart Disease Surgery

Обзор

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

Вмешательства

• Поведенческое JITAI-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 intervent
• Поведенческое Standard 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.

Первичные конечные точки

• Change in Six-Minute Walk Distance (6MWD) [Срок оценки: Baseline to post-intervention (approximately 7-10 days postoperative period)]
• Cardiac Function Parameters (LVEF, FS) [Срок оценки: Baseline to Post-intervention (within 7-10 days after surgery)]
• Lower Extremity Muscle Strength [Срок оценки: Baseline to Post-intervention (within 7-10 days after surgery)]

Вторичные конечные точки (4)

• Training Adherence Rate [Срок оценки: Assessed at discharge]
• Change in Exercise Fear (TSK-C Score) [Срок оценки: From baseline to 4 weeks after the intervention]
• Exercise enjoyment score [Срок оценки: Within 24 hours after completion of the intervention]
• Incidence, number, and type of exercise-training safety events [Срок оценки: From baseline (first exercise training session) through hospital discharge, up to [30 days].]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Поддерживающая терапия

Центры проведения

Китай · 1 центр

• Zhejiang University School of Medicine Children's Hospital — Ханчжоу

Публикации

• 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 30590757
• 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. PMID 27663578

Идентификаторы

NCT: NCT07574463 · 2026-IRB-0019

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗