Adaptive Digital Exercise Rehabilitation for Children After CHD Surgery

May 5, 2026 updated by: 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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

130

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Zhejiang
      • Hangzhou, Zhejiang, China, 31000
        • Zhejiang University School of Medicine Children's Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
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 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.
Active Comparator: Standard Rehabilitation Care Group
Participants will receive standard postoperative exercise rehabilitation according to current clinical guidelines, without adaptive digital adjustments.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Six-Minute Walk Distance (6MWD)
Time Frame: Baseline to post-intervention (approximately 7-10 days postoperative period)
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.
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)
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.
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)
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.
Baseline to Post-intervention (within 7-10 days after surgery)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Training Adherence Rate
Time Frame: Assessed at discharge
Percentage of prescribed training sessions completed by participants. Higher percentage indicates better adherence.
Assessed at discharge
Change in Exercise Fear (TSK-C Score)
Time Frame: From baseline to 4 weeks after the intervention
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.
From baseline to 4 weeks after the intervention
Exercise enjoyment score
Time Frame: Within 24 hours after completion of the intervention
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.
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].
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.
From baseline (first exercise training session) through hospital discharge, up to [30 days].

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Children's Hospital of Zhejiang University School of Medicine

Collaborators

Beijing Children's Hospital
Children's Hospital of Nanjing Medical University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

December 30, 2026

Primary Completion (Estimated)

January 30, 2029

Study Completion (Estimated)

February 28, 2029

Study Registration Dates

First Submitted

January 28, 2026

First Submitted That Met QC Criteria

May 5, 2026

First Posted (Actual)

May 8, 2026

Study Record Updates

Last Update Posted (Actual)

May 8, 2026

Last Update Submitted That Met QC Criteria

May 5, 2026

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2026-IRB-0019

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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