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

NCT07558954 | Not Yet Recruiting

• 1 other identifier: 2026-IRB-0029
• Study Type: interventional
• Target: 92
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Asthma Childhood

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline

Secondary Outcomes (1)

• Pulmonary function

  Baseline

Study Arms (2)

Family-empowered pulmonary rehabilitation intervention group

EXPERIMENTAL

Behavioral: Family-empowered pulmonary rehabilitation

Conventional pulmonary rehabilitation care group

OTHER

Behavioral: Conventional pulmonary rehabilitation care

Interventions

Family-empowered pulmonary rehabilitation BEHAVIORAL

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

Family-empowered pulmonary rehabilitation intervention group

Conventional pulmonary rehabilitation care BEHAVIORAL

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

Conventional pulmonary rehabilitation care group

Eligibility Criteria

• Age: 6 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The Children's Hospital of Zhejiang University School of Medicine: lead

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 27, 2026
• First Posted: April 30, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): October 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: April 30, 2026

Record last verified: 2026-02