Congenital Heart Disease (CHD)NCT07055347
Feasibility Study of Home Cardiac Rehabilitation Program for Postoperative Children With Congenital Heart Disease
A study testing Comprehensive Home-based Cardiac Rehabilitation Program for Postoperative Congenital Heart Disease Patients and Their Caregivers in people with Congenital Heart Disease (CHD) and Preschool Children, run by Sun Yat-sen University.
Trial summary
This single-arm feasibility study will pilot a home-based cardiac rehabilitation program for preschool children (aged 3 to 7 years) who have undergone corrective surgery for congenital heart disease. Read more about this study
- Who is it for?
- Ages 3 to 9 years
- Conditions the study is for
- Congenital Heart Disease (CHD), Preschool Children, Rehabilitation
- What is being tested?
- Comprehensive Home-based Cardiac Rehabilitation Program for Postoperative Congenital Heart Disease Patients and Their Caregivers
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2025to 20 Feb 2026
- 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 3 to 9 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Meet the diagnostic criteria for congenital heart disease
- Aged between 3 and 7 years
- Underwent open-heart congenital heart disease correction surgery at the research institution and achieved correction in a single surgery
- Have been discharged after completing inpatient postoperative rehabilitation
- Able to communicate in Chinese
- The primary caregiver of the child, limited to the child's father or mother
- Among parents, the one who has provided care for the longest duration
- Able to communicate in Chinese
Who cannot join
- Postoperative arrhythmia
- Neurological, respiratory, or other comorbid diseases in addition to congenital heart disease and assessed by a physician as unsuitable for exercise
- Cardiac function classified as NYHA Class IV
- Intellectual, language, or motor impairments resulting from perioperative complications or other causes
- Caregivers of Children With Congenital Heart Disease After Surgery
- Caregivers of children who voluntarily discontinued treatment before its completion
Show all 11Show fewer
- Paid or non-parental caregivers
- Individuals with diagnosed cognitive impairment or mental illness
- Inability to communicate effectively through spoken language
- Serious conflict or instability in the caregiver-child relationship
- Inability to independently operate and use smart electronic devices and internet-based tools
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
This single-arm feasibility study will pilot a home-based cardiac rehabilitation program for preschool children (aged 3 to 7 years) who have undergone corrective surgery for congenital heart disease. Following the development of the program through expert consensus, this phase will implement the preliminary version of the program in a selected sample of caregiver-child pairs over a 12-week period. The study will assess feasibility by evaluating caregiver adherence to the intervention, acceptability of the program components, and completeness of rehabilitation task records. Descriptive data on safety, participation rate, and delivery logistics will also be collected. Findings will inform refinement of the program prior to future effectiveness testing.
- Being tested
- Comprehensive Home-based Cardiac Rehabilitation Program for Postoperative Congenital Heart Disease Patients and Their Caregivers
- Keywords
- Congenital Heart Disease, preschool children, Postoperative heart rehabilitation, Home rehabilitation
- 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.
Comprehensive Home-based Cardiac Rehabilitation Program for Postoperative Congenital Heart Disease Patients and Their CaregiversOther
Intervention Description: For children, provide age-appropriate rehab manuals with pictures and texts to encourage participation. Include gentle physical activities, breathing and stretching exercises. For caregivers, offer detailed manuals and checklists. Organize training. Manage drugs with personalized guidance. Provide health education for both via manuals and video consultations. Focus on mental and physical health with support and activities. Regular phone follow-ups ensure nursing continuity. Multidisciplinary team offers professional support through video consultations and referrals.
| Study group | Role | What they receive |
|---|---|---|
| Home-based cardiac rehabilitation group | Experimental | Participants in this arm will receive a structured home-based cardiac rehabilitation program designed for preschool children (aged 3-7 years) who have undergone corrective surgery for congenital heart disease. The program includes modules on physical activity, breathing exercises, emotional support, and caregiver education. Caregivers will implement the 12-week intervention at home with support materials and guidance provided by the research team. Receives: Other: Comprehensive Home-based Cardiac Rehabilitation Program for Postoperative Congenital Heart Disease Patients and Their Caregivers |
What is being measured
The primary outcome is the main question the study is designed to answer.
Caregiver Adherence Rate to the Home Rehabilitation Program
During the pilot implementation phase of the home-based rehabilitation program, caregivers will be asked to assist their children in completing assigned daily tasks (e.g., physical activities, breathing exercises, emotional support). Adherence will be tracked using daily caregiver logs. The outcome will be calculated as the percentage of completed tasks over the total assigned tasks per participant. Summary statistics (mean ± SD) will be reported.
Measured: Up to 4 weeks post-enrollment (exact duration to be finalized)
Secondary outcomes (2)
Rehabilitation Program Data
collect rehabilitation indicators from caregivers in the form of photos (resting heart rate, heart rate during exercise, Borg's perceived exertion score before and after exercise, complexion, lip color, child's complaint).
Measured: At 7 and 14 days after implementation
Feedback survey
Collect feedback on the trial of the rehabilitation program from caregivers and some older children via phone or online video conference. Focus on collecting compliance-related indicators (e.g., whether rehabilitation training items are completed on time and as required, whether relevant drugs are taken at the prescribed dose, etc.) and acceptability-related indicators (e.g., acceptance of rehabilitation training intensity, methods, duration, etc.).
Measured: At 7 and 14 days after implementation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2025
- Study start1 Aug 2025 (estimated)
- Primary completion30 Dec 2025 (estimated)
- Study completion20 Feb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Congenital Heart Disease (CHD)Studies of the same condition, open and under way.
- More trials run by Sun Yat-sen UniversityThe sponsor's other registered studies.
- 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
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wei XIA, PhD, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07055347
- Sponsor's protocol ID
- LSLL2024-801-2
- Status last verified
- Jun 2025
- First submitted
- 21 Jun 2025
- Last updated
- 8 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility Study of Home Cardiac Rehabilitation Program for Postoperative Children With Congenital Heart Disease
- ClinicalTrials.gov ID
- NCT07055347
- Acronym / sponsor ID
- LSLL2024-801-2
- Keywords
- Congenital Heart Disease, preschool children, Postoperative heart rehabilitation, Home rehabilitation
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 5 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 1 Aug 2025 (estimated)
- Primary completion
- 30 Dec 2025 (estimated)
- Study completion
- 20 Feb 2026 (estimated)
- First posted
- 8 Jul 2025 (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.
This single-arm feasibility study will pilot a home-based cardiac rehabilitation program for preschool children (aged 3 to 7 years) who have undergone corrective surgery for congenital heart disease. Following the development of the program through expert consensus, this phase will implement the preliminary version of the program in a selected sample of caregiver-child pairs over a 12-week period. The study will assess feasibility by evaluating caregiver adherence to the intervention, acceptability of the program components, and completeness of rehabilitation task records. Descriptive data on safety, participation rate, and delivery logistics will also be collected. Findings will inform refinement of the program prior to future effectiveness testing.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Home-based cardiac rehabilitation group | Experimental | Other: Comprehensive Home-based Cardiac Rehabilitation Program for Postoperative Congenital Heart Disease Patients and Their CaregiversParticipants in this arm will receive a structured home-based cardiac rehabilitation program designed for preschool children (aged 3-7 years) who have undergone corrective surgery for congenital heart disease. The program includes modules on physical activity, breathing exercises, emotional support, and caregiver education. Caregivers will implement the 12-week intervention at home with support materials and guidance provided by the research team. |
Who may qualify
- Ages
- 3 to 9 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- Meet the diagnostic criteria for congenital heart disease
- Aged between 3 and 7 years
- Underwent open-heart congenital heart disease correction surgery at the research institution and achieved correction in a single surgery
- Have been discharged after completing inpatient postoperative rehabilitation
- Able to communicate in Chinese
Key exclusion criteria (11 listed)
- Postoperative arrhythmia
- Neurological, respiratory, or other comorbid diseases in addition to congenital heart disease and assessed by a physician as unsuitable for exercise
- Cardiac function classified as NYHA Class IV
- Intellectual, language, or motor impairments resulting from perioperative complications or other causes
- Caregivers of Children With Congenital Heart Disease After Surgery
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 |
|---|---|---|
| Comprehensive Home-based Cardiac Rehabilitation Program for Postoperative Congenital Heart Disease Patients and Their CaregiversIntervention Description: For children, provide age-appropriate rehab manuals with pictures and texts to encourage participation. Include gentle physical activities, breathing and stretching exercises. For caregivers, offer detailed manuals and checklists. Organize training. Manage drugs with personalized guidance. Provide health education for both via manuals and video consultations. Focus on mental and physical health with support and activities. Regular phone follow-ups ensure nursing continuity. Multidisciplinary team offers professional support through video consultations and referrals. | Other | Home-based cardiac rehabilitation group |
Primary outcome
Caregiver Adherence Rate to the Home Rehabilitation Program
Time frame: Up to 4 weeks post-enrollment (exact duration to be finalized)
During the pilot implementation phase of the home-based rehabilitation program, caregivers will be asked to assist their children in completing assigned daily tasks (e.g., physical activities, breathing exercises, emotional support). Adherence will be tracked using daily caregiver logs. The outcome will be calculated as the percentage of completed tasks over the total assigned tasks per participant. Summary statistics (mean ± SD) will be reported.
2 secondary outcomes
Rehabilitation Program Data
Time frame: At 7 and 14 days after implementation
Feedback survey
Time frame: At 7 and 14 days after implementation
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 Jul 2025.
- Individual participant dataSharing planned: No
Related trials for Congenital Heart Disease (CHD)
Recruiting
Implementing Models for Mechanical Circulatory Support Presurgical Assessment in Congenital Heart Disease Treatment
Congenital Heart Disease
Recruiting
A Pragmatic Clinical Trial of the WE BEAT Well-Being Education Program in Adolescent Congenital Heart Disease: WE BEAT CHD Study
Patient-Reported Outcome Measures (PROMs), Pragmatic Trial
Active, not recruiting
Learning by Heart: The Effectiveness of an EF Training Program for Pre-schoolers With Critical CHD
Congenital Heart Disease, Executive Dysfunction
Not yet recruitingObservational study
Echocardiographic Assessment of Valvular Dysfunction in Children With CHD
Congenital Heart Disease, Valvular Heart Disease
Not yet recruiting
UltraTrac for Cardiac Output Monitoring in Congenital Heart Disease
Congenital Heart Disease, Cardiac Output
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.
Questions about this trial
What is this clinical trial studying?
A study testing Comprehensive Home-based Cardiac Rehabilitation Program for Postoperative Congenital Heart Disease Patients and Their Caregivers in people with Congenital Heart Disease (CHD) and Preschool Children, run by Sun Yat-sen University.
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 8 inclusion and 11 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 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
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 Xia Wei, PhD (+8618823359471, xiaw23@mail.sysu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Caregiver Adherence Rate to the Home Rehabilitation Program (time frame: Up to 4 weeks post-enrollment (exact duration to be finalized)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Jul 2025.