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

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.

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Key information

Conditions

Asthma Childhood

Age range

6 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Family-empowered pulmonary rehabilitation

Behavioral

Family-empowered pulmonary rehabilitation intervention, including education, skills training, and home-based rehabilitation guidance.

Conventional pulmonary rehabilitation care

Behavioral

Routine pulmonary rehabilitation care and regular follow-up as per clinical practice.

Primary outcomes

Asthma control level

Time frame: 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 outcomes

Pulmonary function

Time frame: Baseline

To evaluate pulmonary function, including FEV1, FVC, and FEV1/FVC ratio.

Sponsors and collaborators

Lead sponsor

The Children's Hospital of Zhejiang University School of Medicine

Other

Registry information

Important dates

Study start: 2026
Primary completion: 2027
Study completion: 2027
First posted: Apr 30, 2026
Registry last updated: Apr 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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