About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- Comprehensive Home-based Cardiac Rehabilitation Program for Postoperative Congenital Heart Disease Patients and Their Caregivers