Asthma ChildhoodNCT07558954
Application Construction and Effect Evaluation of Family-empowered Pulmonary Rehabilitation in School-age Children With Asthma
A study testing Family-empowered pulmonary rehabilitation and Conventional pulmonary rehabilitation care in people with Asthma Childhood, run by The Children's Hospital of Zhejiang University School of Medicine.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 12 years
- Conditions the study is for
- Asthma Childhood
- What is being tested?
- Family-empowered pulmonary rehabilitation and Conventional pulmonary rehabilitation care
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 92 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2026to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
About this study
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
- Being tested
- Family-empowered pulmonary rehabilitation, Conventional pulmonary rehabilitation care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Family-empowered pulmonary rehabilitationBehavioural
Family-empowered pulmonary rehabilitation intervention, including education, skills training, and home-based rehabilitation guidance.
Conventional pulmonary rehabilitation careBehavioural
Routine pulmonary rehabilitation care and regular follow-up as per clinical practice.
| Study group | Role | What they receive |
|---|---|---|
| Family-empowered pulmonary rehabilitation intervention group | Experimental | Not described Receives: Behavioral: Family-empowered pulmonary rehabilitation |
| Conventional pulmonary rehabilitation care group | Other | Not described Receives: Behavioral: Conventional pulmonary rehabilitation care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline
Secondary outcomes (1)
Pulmonary function
To evaluate pulmonary function, including FEV1, FVC, and FEV1/FVC ratio.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2026
- Study start1 May 2026 (estimated)
- Primary completion31 Oct 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Asthma ChildhoodStudies of the same condition, open and under way.
- More trials run by The Children's Hospital of Zhejiang University School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 92 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07558954
- Sponsor's protocol ID
- 2026-IRB-0029
- Status last verified
- Feb 2026
- First submitted
- 27 Feb 2026
- Last updated
- 30 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Application Construction and Effect Evaluation of Family-empowered Pulmonary Rehabilitation in School-age Children With Asthma
- ClinicalTrials.gov ID
- NCT07558954
- Acronym / sponsor ID
- 2026-IRB-0029
- Conditions
- Asthma Childhood
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 92 participants (estimated)
- Lead sponsor
- The Children's Hospital of Zhejiang University School of MedicineUniversity, hospital or other
- Study start
- 1 May 2026 (estimated)
- Primary completion
- 31 Oct 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 30 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Family-empowered pulmonary rehabilitation intervention group | Experimental | Behavioral: Family-empowered pulmonary rehabilitation |
| Conventional pulmonary rehabilitation care group | Other | Behavioral: Conventional pulmonary rehabilitation care |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Family-empowered pulmonary rehabilitationFamily-empowered pulmonary rehabilitation intervention, including education, skills training, and home-based rehabilitation guidance. | Behavioural | Family-empowered pulmonary rehabilitation intervention group |
| Conventional pulmonary rehabilitation careRoutine pulmonary rehabilitation care and regular follow-up as per clinical practice. | Behavioural | Conventional pulmonary rehabilitation care group |
Primary outcome
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.
1 secondary outcome
Pulmonary function
Time frame: Baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Family-empowered pulmonary rehabilitation and Conventional pulmonary rehabilitation care in people with Asthma Childhood, run by The Children's Hospital of Zhejiang University School of Medicine.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 30 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Asthma control level (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2026.