Asthma Childhood
Conditions
Brief summary
Study Purpose: To develop a pulmonary rehabilitation intervention program suitable for school-age children with asthma, and to evaluate its effectiveness in improving asthma control in children through a prospective randomized controlled trial. Study Methods: This is a single-center, prospective, randomized, open-label, parallel-controlled trial. Eligible subjects who meet all inclusion criteria and none of the exclusion criteria, together with their families, will be randomly assigned in a 1:1 ratio to either the intervention group (family-empowered pulmonary rehabilitation intervention) or the control group (conventional pulmonary rehabilitation care) after signing the informed consent form. Both groups will receive a 12-week core intervention period, with follow-up assessments conducted at baseline, end of intervention (12 weeks), and at 24 and 48 weeks after intervention.
Interventions
BEHAVIORALFamily-empowered pulmonary rehabilitation
Family-empowered pulmonary rehabilitation intervention, including education, skills training, and home-based rehabilitation guidance.
BEHAVIORALConventional pulmonary rehabilitation care
Routine pulmonary rehabilitation care and regular follow-up as per clinical practice.
Sponsors
The Children's Hospital of Zhejiang University School of Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
6 Years to 12 Years
Healthy volunteers
No
Inclusion criteria
(All must be met) * School-aged children aged 6 to 12 years. * Meet the diagnostic criteria for asthma according to the Guidelines for the Diagnosis and Prevention of Bronchial Asthma in Children (2025 Edition). * Received regular inhaled asthma medications for at least 3 months, with moderate or better medication adherence (score ≥6 on the Morisky Medication Adherence Scale). * Pulmonary function test shows obstructive ventilatory dysfunction or small airway dysfunction. * The primary caregiver has good communication and literacy skills, can use smartphone applications (e.g., WeChat) proficiently, and is willing to participate in the study. * Written informed consent has been obtained from the participant and their legal guardian.
Exclusion criteria
(Any one leads to exclusion) * Children in acute asthma exacerbation. * Presence of other severe chronic diseases (e.g., congenital heart disease, neuromuscular disease, immunodeficiency disease, etc.). * Children with mental or psychological disorders who cannot cooperate. * Other conditions judged by the investigator to be unsuitable for participation in this study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Asthma control level | Baseline | Evaluate using the change in the Childhood Asthma Control Test (C-ACT) score. The C-ACT score ranges from 0 to 27, with higher scores indicating better control. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pulmonary function | Baseline | To evaluate pulmonary function, including FEV1, FVC, and FEV1/FVC ratio. |
Outcome results
None listed