Application Construction and Effect Evaluation of Family-empowered Pulmonary Rehabilitation in School-age Children With Asthma
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Family-empowered pulmonary rehabilitation, Conventional pulmonary rehabilitation care.
- Who it may be relevant to
- Registry conditions: Asthma Childhood. Basic parameters: 6 years — 12 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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
- Behavioral Family-empowered pulmonary rehabilitation
Family-empowered pulmonary rehabilitation intervention, including education, skills training, and home-based rehabilitation guidance. - Behavioral Conventional pulmonary rehabilitation care
Routine pulmonary rehabilitation care and regular follow-up as per clinical practice.
Primary outcome measures
- Asthma control level [Time frame: Baseline]
Secondary outcome measures (1)
- Pulmonary function [Time frame: Baseline]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07558954 · 2026-IRB-0029