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

NCT ID: NCT07055347

Last Updated: 2025-07-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

5 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-08-01

Study Completion Date

2026-02-20

Brief Summary

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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.

Detailed Description

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Conditions

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Congenital Heart Disease (CHD) Preschool Children Rehabilitation

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Home-based cardiac rehabilitation group

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.

Group Type EXPERIMENTAL

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

Intervention Type 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.

Interventions

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

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.

Intervention Type OTHER

Eligibility Criteria

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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


* 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
* Inability to independently operate and use smart electronic devices and internet-based tools
Minimum Eligible Age

3 Years

Maximum Eligible Age

9 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sun Yat-sen University

OTHER

Sponsor Role lead

Responsible Party

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Wei XIA, PhD

Association Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Central Contacts

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Xia Wei, PhD

Role: CONTACT

+8618823359471

Luo Cong, Master

Role: CONTACT

+8619731525206

Other Identifiers

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LSLL2024-801-2

Identifier Type: -

Identifier Source: org_study_id

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