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Not yet recruiting NCT07574463

Adaptive Digital Exercise Rehabilitation for Children After CHD Surgery

No phase Interventional Congenital Heart Disease (CHD) Congenital Heart Disease in Children

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: JITAI-Based Digital Exercise Rehabilitation Program, Standard Exercise Rehabilitation Program.
Who it may be relevant to
Registry conditions: Congenital Heart Disease (CHD), Congenital Heart Disease in Children. Basic parameters: 6 years — 12 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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

Interventions

  • Behavioral 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
  • Behavioral 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.

Primary outcome measures

  • Change in Six-Minute Walk Distance (6MWD) [Time frame: Baseline to post-intervention (approximately 7-10 days postoperative period)]
  • Cardiac Function Parameters (LVEF, FS) [Time frame: Baseline to Post-intervention (within 7-10 days after surgery)]
  • Lower Extremity Muscle Strength [Time frame: Baseline to Post-intervention (within 7-10 days after surgery)]
Secondary outcome measures (4)
  • Training Adherence Rate [Time frame: Assessed at discharge]
  • Change in Exercise Fear (TSK-C Score) [Time frame: From baseline to 4 weeks after the intervention]
  • Exercise enjoyment score [Time frame: Within 24 hours after completion of the intervention]
  • Incidence, number, and type of exercise-training safety events [Time frame: From baseline (first exercise training session) through hospital discharge, up to [30 days].]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Supportive care

Study locations

China · 1 center
  • Zhejiang University School of Medicine Children's Hospital — Hangzhou

Publications

  • 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

Identifiers

NCT: NCT07574463 · 2026-IRB-0019

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗