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Feasibility Study of Home Cardiac Rehabilitation Program for Postoperative Children With Congenital Heart Disease | Clinical Trials | Clareo Health

NOT_YET_RECRUITINGNA

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

NCT07055347•Sun Yat-sen University

View on ClinicalTrials.gov

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.

Eligibility

Age

3 - 9 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Children With Congenital Heart Disease After Surgery
•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

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
•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
+1 more criteria

Key Dates

Start Date

August 1, 2025

Primary Completion Date

December 30, 2025

Completion Date

February 20, 2026

Last Updated

July 8, 2025

Enrollment

ESTIMATED participants

Conditions

Congenital Heart Disease (CHD)Preschool ChildrenRehabilitation

Interventions

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

OTHER

Contacts

Xia Wei, PhD

CONTACT

+8618823359471 xiaw23@mail.sysu.edu.cn

Luo Cong, Master

CONTACT

+8619731525206 luoc3@mail.sysu.edu.cn

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 8, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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