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Search / Trial NCT07055347

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

Launched by SUN YAT-SEN UNIVERSITY · Jun 27, 2025

Trial Information

Current as of July 22, 2025

Not yet recruiting

Keywords

Congenital Heart Disease Preschool Children Postoperative Heart Rehabilitation Home Rehabilitation

ClinConnect Summary

This clinical trial is testing a new home-based heart rehabilitation program designed for young children aged 3 to 7 who have had surgery to correct congenital heart disease (a heart condition present from birth). The goal is to see if this program, which families can do at home, is practical and easy to follow. The program will be tried out with a small group of children and their main caregivers over 12 weeks to check how well families stick to it, how they feel about the activities, and whether the rehabilitation tasks are completed as planned. The study will also look at safety and how the program is delivered, helping researchers improve it before testing how well it works.

To join, children must have had successful heart surgery at the study hospital, be between 3 and 7 years old, and be able to communicate in Chinese. Children with serious complications like irregular heartbeats, other major health problems, or severe heart failure won’t be eligible. Caregivers need to be the child’s parent who has been the main person caring for them and able to use smart devices and the internet, since the program will likely involve digital tools. Participants can expect to follow a guided rehabilitation plan at home, with support from the study team, aimed at helping the child recover and stay active after surgery.

Gender

ALL

Eligibility 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

About Sun Yat Sen University

Sun Yat-sen University, a prestigious institution located in Guangzhou, China, is dedicated to advancing medical research and healthcare innovations. As a leading clinical trial sponsor, the university leverages its extensive academic resources and collaboration with top-tier medical professionals to conduct rigorous clinical studies. Committed to improving patient outcomes and contributing to global health knowledge, Sun Yat-sen University focuses on a wide range of therapeutic areas, employing cutting-edge methodologies to ensure the integrity and efficacy of its research initiatives. Through its clinical trials, the university aims to foster scientific advancements and enhance the quality of care provided to patients both locally and internationally.

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Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported