Congenital Heart Disease (CHD)NCT07574463
Adaptive Digital Exercise Rehabilitation for Children After CHD Surgery
A study testing JITAI-Based Digital Exercise Rehabilitation Program and Standard Exercise Rehabilitation Program in people with Congenital Heart Disease (CHD) and Congenital Heart Disease in Children, run by The Children's Hospital of Zhejiang University School of Medicine at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 6 to 12 years
- Conditions the study is for
- Congenital Heart Disease (CHD), Congenital Heart Disease in Children
- What is being tested?
- JITAI-Based Digital Exercise Rehabilitation Program and Standard Exercise Rehabilitation Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- 1 siteChina
- Study dates
- 30 Dec 2026to 28 Feb 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Zhejiang University School of Medicine Children's Hospital
Hangzhou, Zhejiang, 31000
hua ji Zhu, +86 13588326715, jihuazhu@zju.edu.cn
About this study
Official title: 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.
Read more
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
- Being tested
- JITAI-Based Digital Exercise Rehabilitation Program, Standard Exercise Rehabilitation Program
- Keywords
- Just-in-Time Adaptive Intervention
- Medical subject headings
- Heart Defects, Congenital
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
JITAI-Based Digital Exercise Rehabilitation ProgramBehavioural
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 ProgramBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Adaptive Digital Rehabilitation (JITAI-Based) Group | Experimental | Participants will receive the JITAI-based adaptive digital exercise rehabilitation program supported by wearable monitoring devices and the digital rehabilitation platform. Receives: Behavioral: JITAI-Based Digital Exercise Rehabilitation Program |
| Standard Rehabilitation Care Group | Active comparator | Participants will receive standard postoperative exercise rehabilitation according to current clinical guidelines, without adaptive digital adjustments. Receives: Behavioral: Standard Exercise Rehabilitation Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Six-Minute Walk Distance (6MWD)
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.
Measured: Baseline to post-intervention (approximately 7-10 days postoperative period)
Cardiac Function Parameters (LVEF, FS)
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.
Measured: Baseline to Post-intervention (within 7-10 days after surgery)
Lower Extremity Muscle Strength
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.
Measured: Baseline to Post-intervention (within 7-10 days after surgery)
Secondary outcomes (4)
Training Adherence Rate
Percentage of prescribed training sessions completed by participants. Higher percentage indicates better adherence.
Measured: Assessed at discharge
Change in Exercise Fear (TSK-C Score)
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.
Measured: From baseline to 4 weeks after the intervention
Exercise enjoyment score
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.
Measured: Within 24 hours after completion of the intervention
Incidence, number, and type of exercise-training safety events
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.
Measured: From baseline (first exercise training session) through hospital discharge, up to [30 days].
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2026
- Study start30 Dec 2026 (estimated)
- Primary completion30 Jan 2029 (estimated)
- Study completion28 Feb 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Congenital Heart Disease (CHD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 130 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Children's Hospital of Zhejiang University School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Children's Hospital of Nanjing Medical University, Beijing Children's Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07574463
- Sponsor's protocol ID
- 2026-IRB-0019
- Status last verified
- Dec 2025
- First submitted
- 28 Jan 2026
- Last updated
- 8 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 30590757Nahum-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.
PubMed 27663578
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Evaluation of a Just-in-Time Adaptive Digital Exercise Rehabilitation Program for Children After Congenital Heart Disease Surgery
- ClinicalTrials.gov ID
- NCT07574463
- Acronym / sponsor ID
- 2026-IRB-0019
- Keywords
- Just-in-Time Adaptive Intervention
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 130 participants (estimated)
- Lead sponsor
- The Children's Hospital of Zhejiang University School of MedicineUniversity, hospital or other
- Collaborators
- Children's Hospital of Nanjing Medical University, Beijing Children's Hospital
- Study start
- 30 Dec 2026 (estimated)
- Primary completion
- 30 Jan 2029 (estimated)
- Study completion
- 28 Feb 2029 (estimated)
- First posted
- 8 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Adaptive Digital Rehabilitation (JITAI-Based) Group | Experimental | Behavioral: JITAI-Based Digital Exercise Rehabilitation ProgramParticipants will receive the JITAI-based adaptive digital exercise rehabilitation program supported by wearable monitoring devices and the digital rehabilitation platform. |
| Standard Rehabilitation Care Group | Active comparator | Behavioral: Standard Exercise Rehabilitation ProgramParticipants will receive standard postoperative exercise rehabilitation according to current clinical guidelines, without adaptive digital adjustments. |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| JITAI-Based Digital Exercise Rehabilitation ProgramThis 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. | Behavioural | Adaptive Digital Rehabilitation (JITAI-Based) Group |
| Standard Exercise Rehabilitation ProgramA 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. | Behavioural | Standard Rehabilitation Care Group |
Primary outcome
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.
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.
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.
4 secondary outcomes
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].
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2026.
- Results publication: PubMed 30590757Gonul 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.
- Results publication: PubMed 27663578Nahum-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.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing JITAI-Based Digital Exercise Rehabilitation Program and Standard Exercise Rehabilitation Program in people with Congenital Heart Disease (CHD) and Congenital Heart Disease in Children, run by The Children's Hospital of Zhejiang University School of Medicine at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 8 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact hua ji Zhu (+86 13588326715, jihuazhu@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Six-Minute Walk Distance (6MWD) (time frame: Baseline to post-intervention (approximately 7-10 days postoperative period)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07574463, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2026.