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Safety and Efficacy Study of Early Postoperative Cardiac Rehabilitation Management Protocols in Children and Adolescents Following Congenital Heart Disease Surgery

Safety and Efficacy Study of Early Postoperative Cardiac Rehabilitation Management Protocols in Children and Adolescents Following Congenital Heart Disease Surgery

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500103565
Enrollment
Unknown
Registered
2025-05-30
Start date
2025-04-01
Completion date
Unknown
Last updated
2025-06-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

congenital heart disease

Interventions

cardiac rehabilitation management group:routine diagnosis and treatment procedures + cardiac rehabilitation management
control group:routine diagnosis and treatment procedures

Sponsors

Fuwai Hospital, CAMS & PUMC
Lead Sponsor

Eligibility

Sex/Gender
All
Age
6 Years to 18 Years

Inclusion criteria

Inclusion criteria: 1. Patients must meet ALL of the following: (1) Diagnosis of simple or complex congenital heart disease; (2) Undergoing definitive surgical correction under cardiopulmonary bypass (CPB) as an elective procedure at this center; (3) Aged >=6 years and <18 years at the time of surgery; 2.Provision of written informed consent by legal guardian(s) with willingness to voluntarily participate in the study and comply with follow-up requirements

Exclusion criteria

Exclusion criteria: 1. Age at surgery =18 years; 2. Presence of symptomatic or medically/surgically managed non-structural cardiac diseases (including arrhythmias, cardiomyopathies) or acquired heart diseases (including infective endocarditis, acquired valvular diseases, myocarditis); 3. Concurrent symptomatic or medically/surgically managed non-cardiac systemic diseases; 4. History of cardiac surgery or intensive care unit (ICU) admission within the past year; 5. Anticipated requirement for repeat cardiac surgery under cardiopulmonary bypass (CPB) within 12 months postoperatively, as determined by investigators; 6. Medical contraindications to surgery or CPB, as assessed by investigators; 7. Preoperative hospitalization <24 hours, postoperative hospitalization <5 days, or insufficient time for complete perioperative rehabilitation protocol implementation according to investigator judgment; 8. Current participation in other interventional trials or planned enrollment during study period; 9. Inability to complete baseline cardiopulmonary exercise testing (CPET) or Health-Related Quality of Life (HRQoL) assessments; 10. Special circumstances (including pregnancy, substance abuse).

Design outcomes

Primary

MeasureTime frame
CPET indexes;

Secondary

MeasureTime frame
Safety indicators (including death, readmission, reoperation, cardiovascular events, and non-cardiovascular events);The compliance of the subjects in following the CR regimen;Length of stay (total hospital stay, postoperative hospital stay, ICU stay);Severity score of disease;physical development state;Health and physical fitness;Nutritional and immune status;Cardiac function;Heart rate and heart rhythm conditions;Condition of the lungs;Respiratory function;Subject's health-related quality of life;Subject's disease knowledge;Caregiver's emotional and quality of life;

Countries

China

Contacts

Public ContactWenxin Lu, Xue Feng

Fuwai Hospital, CAMS & PUMC

faylll@126.com+86 151 2005 5190

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026