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NCT Number: NCT07055347

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

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.

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Key information

Conditions

Congenital Heart Disease (CHD) Cardiovascular Abnormalities Cardiovascular Diseases Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Heart Defects, Congenital Heart Diseases Preschool Children Rehabilitation

Age range

3 year–9 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

Caregiver Adherence Rate to the Home Rehabilitation Program

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

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.

Secondary outcomes

Rehabilitation Program Data

Time frame: At 7 and 14 days after implementation

collect rehabilitation indicators from caregivers in the form of photos (resting heart rate, heart rate during exercise, Borg's perceived exertion score before and after exercise, complexion, lip color, child's complaint).
Feedback survey

Time frame: At 7 and 14 days after implementation

Collect feedback on the trial of the rehabilitation program from caregivers and some older children via phone or online video conference. Focus on collecting compliance-related indicators (e.g., whether rehabilitation training items are completed on time and as required, whether relevant drugs are taken at the prescribed dose, etc.) and acceptability-related indicators (e.g., acceptance of rehabilitation training intensity, methods, duration, etc.).

Study contacts

Contact information is provided by the study sponsor or research team.

Luo Cong, Master

CONTACT

[email protected]

+8619731525206

Xia Wei, PhD

CONTACT

[email protected]

+8618823359471

Sponsors and collaborators

Lead sponsor

Sun Yat-sen University

Other

Registry information

Important dates

Study start: 2025
Primary completion: 2025
Study completion: 2026
First posted: Jul 8, 2025
Registry last updated: Jul 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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