Feasibility Study of Home Cardiac Rehabilitation Program for Postoperative Children With Congenital Heart Disease

Sun Yat-sen University

Status: Not yet enrolling

Conditions: Rehabilitation; Preschool Children; Congenital Heart Disease (CHD)

Treatments: Other: Comprehensive Home-based Cardiac Rehabilitation Program for Postoperative Congenital Heart Disease Patients and Their Caregivers

Study type: Interventional

Funder types: Other

Identifiers

NCT07055347

LSLL2024-801-2

Details and patient eligibility

About

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.

Enrollment: 5 estimated patients

Sex: All

Ages: 3 to 9 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Exclusion Criteria:

• Caregivers of children who voluntarily discontinued treatment before its completion
• 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 design

Primary purpose: Health Services Research

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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5 participants in 1 patient group

Home-based cardiac rehabilitation group

Experimental group

Description:

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.

Treatment:

Other: Comprehensive Home-based Cardiac Rehabilitation Program for Postoperative Congenital Heart Disease Patients and Their Caregivers