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Application Construction and Effect Evaluation of Family-empowered Pulmonary Rehabilitation in School-age Children With Asthma

NCT07558954

Not Yet RecruitingNA

Sponsor: The Children's Hospital of Zhejiang University School of Medicine

Conditions: Asthma Childhood

Interventions: Family-empowered pulmonary rehabilitation, Conventional pulmonary rehabilitation care

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 overview

Sex: ALL

Age: 6 Years to 12 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

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.