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.
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.
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.
Parallel
Family-empowered pulmonary rehabilitation
BehavioralFamily-empowered pulmonary rehabilitation intervention, including education, skills training, and home-based rehabilitation guidance.
Conventional pulmonary rehabilitation care
BehavioralRoutine pulmonary rehabilitation care and regular follow-up as per clinical practice.
Asthma control level
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.
Pulmonary function
To evaluate pulmonary function, including FEV1, FVC, and FEV1/FVC ratio.
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