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NCT Number: NCT07574463

Adaptive Digital Exercise Rehabilitation for Children After CHD 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

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Key information

Conditions

Congenital Heart Disease (CHD) Cardiovascular Abnormalities Cardiovascular Diseases Congenital Abnormalities Congenital Heart Disease in Children Congenital, Hereditary, and Neonatal Diseases and Abnormalities Heart Defects, Congenital Heart Diseases

Age range

6 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

JITAI-Based Digital Exercise Rehabilitation Program

Behavioral

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.

Standard Exercise Rehabilitation Program

Behavioral

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 outcomes

  1. 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.

  2. 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.

  3. 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.

Secondary outcomes

  1. Training Adherence Rate

    Time frame: Assessed at discharge

    Percentage of prescribed training sessions completed by participants. Higher percentage indicates better adherence.

  2. 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.

  3. 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.

  4. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

hua ji Zhu

CONTACT

[email protected]

+86 13588326715

Sponsors and collaborators

Lead sponsor

The Children's Hospital of Zhejiang University School of Medicine

Other

Collaborators

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

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2029
Study completion
2029
First posted
May 8, 2026
Registry last updated
May 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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