Adaptive Digital Exercise Rehabilitation for Children After CHD Surgery
2026년 5월 5일 업데이트: 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
연구 개요
상태
아직 모집하지 않음
연구 유형
중재적
등록 (추정된)
130
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 연락처
- 이름: hua ji Zhu
- 전화번호: +86 13588326715
- 이메일: jihuazhu@zju.edu.cn
연구 장소
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Zhejiang
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Hangzhou, Zhejiang, 중국, 31000
- Zhejiang University School of Medicine Children's Hospital
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연락하다:
- hua ji Zhu
- 전화번호: +86 13588326715
- 이메일: jihuazhu@zju.edu.cn
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
- 어린이
건강한 자원 봉사자를 받아들입니다
아니
설명
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
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 지지 요법
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: 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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활성 비교기: 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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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Change in Six-Minute Walk Distance (6MWD)
기간: 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)
기간: 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
기간: 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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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Training Adherence Rate
기간: 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)
기간: 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
기간: 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
기간: 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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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
간행물 및 유용한 링크
연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.
일반 간행물
- 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.
유용한 링크
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (추정된)
2026년 12월 30일
기본 완료 (추정된)
2029년 1월 30일
연구 완료 (추정된)
2029년 2월 28일
연구 등록 날짜
최초 제출
2026년 1월 28일
QC 기준을 충족하는 최초 제출
2026년 5월 5일
처음 게시됨 (실제)
2026년 5월 8일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2026년 5월 8일
QC 기준을 충족하는 마지막 업데이트 제출
2026년 5월 5일
마지막으로 확인됨
2025년 12월 1일
추가 정보
이 연구와 관련된 용어
키워드
추가 관련 MeSH 약관
기타 연구 ID 번호
- 2026-IRB-0019
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
아니요
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
아니
미국 FDA 규제 기기 제품 연구
아니
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .