About this trial
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Family-empowered pulmonary rehabilitation
- Conventional pulmonary rehabilitation care