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

NCT07055347 | Not Yet Recruiting

• 1 other identifier: LSLL2024-801-2
• Study Type: interventional
• Target: 5
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Congenital Heart Disease (CHD); Preschool Children; Rehabilitation

Keywords

Congenital Heart Disease; preschool children; Postoperative heart rehabilitation; Home rehabilitation

Outcome Measures

Primary Outcomes (1)

• 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.

  Up to 4 weeks post-enrollment (exact duration to be finalized)

Secondary Outcomes (2)

• Rehabilitation Program Data

  At 7 and 14 days after implementation

• Feedback survey

  At 7 and 14 days after implementation

Study Arms (1)

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.

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

Interventions

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

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.

Home-based cardiac rehabilitation group

Eligibility Criteria

• Age: 3 Years - 9 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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
• 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

Sponsors & Collaborators

• Sun Yat-sen University: lead

MeSH Terms

Conditions

Heart Defects, Congenital

Condition Hierarchy (Ancestors)

Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Central Study Contacts

Xia Wei, PhD

CONTACT

+8618823359471; xiaw23@mail.sysu.edu.cn

Luo Cong, Master

CONTACT

+8619731525206; luoc3@mail.sysu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Association Professor

Study Record Dates

• First Submitted: June 21, 2025
• First Posted: July 8, 2025
• Study Start: August 1, 2025
• Primary Completion: December 30, 2025
• Study Completion: February 20, 2026
• Last Updated: July 8, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share