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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age3-9
SponsorSun Yat-sen University

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

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

    Other intervention

    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.

Treatment groups

5 Participants
are divided into 1 treatment group
Group A: Home-based cardiac rehabilitation groupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Caregiver Adherence Rate to the Home Rehabilitation Program

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.

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

Secondary outcomes

1

Rehabilitation Program Data

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).

Time frame
At 7 and 14 days after implementation
2

Feedback survey

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.).

Time frame
At 7 and 14 days after implementation

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

This trial is not recruiting at the moment. You can still explore other options: