Adaptive Digital Exercise Rehabilitation for Children After CHD Surgery
5. Mai 2026 aktualisiert von: 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
Studienübersicht
Status
Noch keine Rekrutierung
Studientyp
Interventionell
Einschreibung (Geschätzt)
130
Phase
- Unzutreffend
Kontakte und Standorte
Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.
Studienkontakt
- Name: hua ji Zhu
- Telefonnummer: +86 13588326715
- E-Mail: jihuazhu@zju.edu.cn
Studienorte
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Zhejiang
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Hangzhou, Zhejiang, China, 31000
- Zhejiang University School of Medicine Children's Hospital
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Kontakt:
- hua ji Zhu
- Telefonnummer: +86 13588326715
- E-Mail: jihuazhu@zju.edu.cn
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Teilnahmekriterien
Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.
Zulassungskriterien
Studienberechtigtes Alter
- Kind
Akzeptiert gesunde Freiwillige
Nein
Beschreibung
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
Studienplan
Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Unterstützende Pflege
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Single
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
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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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Aktiver Komparator: 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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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
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Change in Six-Minute Walk Distance (6MWD)
Zeitfenster: 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)
Zeitfenster: 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
Zeitfenster: 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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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Training Adherence Rate
Zeitfenster: 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)
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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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Mitarbeiter und Ermittler
Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.
Publikationen und hilfreiche Links
Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.
Allgemeine Veröffentlichungen
- 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.
Nützliche Links
Studienaufzeichnungsdaten
Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.
Haupttermine studieren
Studienbeginn (Geschätzt)
30. Dezember 2026
Primärer Abschluss (Geschätzt)
30. Januar 2029
Studienabschluss (Geschätzt)
28. Februar 2029
Studienanmeldedaten
Zuerst eingereicht
28. Januar 2026
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
5. Mai 2026
Zuerst gepostet (Tatsächlich)
8. Mai 2026
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
8. Mai 2026
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
5. Mai 2026
Zuletzt verifiziert
1. Dezember 2025
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- 2026-IRB-0019
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Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
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