Congenital Heart Disease (CHD), Preschool Children, Rehabilitation
Conditions
Keywords
Congenital Heart Disease, preschool children, Postoperative heart rehabilitation, Home rehabilitation
Brief 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. 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.
Interventions
OTHERComprehensive Home-based Cardiac Rehabilitation Program for Postoperative Congenital Heart Disease Patients and Their Caregivers
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.
Sponsors
Sun Yat-sen University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
3 Years to 9 Years
Healthy volunteers
No
Inclusion criteria
Children With Congenital Heart Disease After Surgery Inclusion Criteria: * 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
Exclusion criteria
* 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 Inclusion Criteria: * 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Caregiver Adherence Rate to the Home Rehabilitation Program | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Rehabilitation Program Data | At 7 and 14 days after implementation | 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). |
| Feedback survey | At 7 and 14 days after implementation | 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.). |
Contacts
Primary ContactXia Wei, PhD
Backup ContactLuo Cong, Master
Outcome results
None listed