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

April 26, 2026 updated by: The Children's Hospital of Zhejiang University School of Medicine

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

92

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Family-empowered pulmonary rehabilitation intervention group
Behavioral: Family-empowered pulmonary rehabilitation
Family-empowered pulmonary rehabilitation intervention, including education, skills training, and home-based rehabilitation guidance.
Other: Conventional pulmonary rehabilitation care group
Behavioral: Conventional pulmonary rehabilitation care
Routine pulmonary rehabilitation care and regular follow-up as per clinical practice.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pulmonary function
Time Frame: Baseline
To evaluate pulmonary function, including FEV1, FVC, and FEV1/FVC ratio.
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Children's Hospital of Zhejiang University School of Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

May 1, 2026

Primary Completion (Estimated)

October 31, 2027

Study Completion (Estimated)

December 31, 2027

Study Registration Dates

First Submitted

February 27, 2026

First Submitted That Met QC Criteria

April 26, 2026

First Posted (Actual)

April 30, 2026

Study Record Updates

Last Update Posted (Actual)

April 30, 2026

Last Update Submitted That Met QC Criteria

April 26, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

  • 2026-IRB-0029

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Asthma Childhood

Clinical Trials on Family-empowered pulmonary rehabilitation

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Denmark

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe