Active Airways for Children and Young People With Asthma

June 9, 2026 updated by: University of Leicester

The Feasibility of an Exercise and Asthma Educational Programme 'Active Airways' on Health Outcomes in Children and Young People With Asthma With All Severities

What is this study about? The investigators want to see if exercise and education sessions can help children and young people (aged 10-17) with asthma, manage the participants asthma better.

The investigators will place participants that are recruited to this study into one of three groups by a computer (randomly):

Group 1:

Usual Care: Continue with normal asthma treatment.

Group 2:

Education: Usual care + a 45-minute online asthma education class once a week.

Group 3:

Exercise & Education: Usual care + 3 exercise sessions a week and asthma education classes.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

This research aims to identify if an exercise and/or asthma education programme, called 'Active Airways', is feasible and acceptable in the paediatric asthma patient. Feasibility, the primary outcome of this study, will be evaluated by calculating the percentage of people approached who participate in the intervention (recruitment) and the percentage who complete the intervention (retention and adherence). The investigators also want to see if the Active Airways programme could improve cardiorespiratory fitness, quality of life and lung function, reduce asthma attacks and reduce healthcare use.

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

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:

Willing and able to consent to participate in the trial

Able to understand written and spoken English

A diagnosis of Mild to Moderate Asthma or Severe Asthma based on the European Respiratory Society (ERS)/ American Thoracic Society (ATS) consensus statement on Severe Asthma

Able to participate in a formal exercise programme

Aged 10-17 years

Able to engage in focus groups

Approximately 130cm tall (to be able to complete cardiopulmonary exercise testing (CPET))

Exclusion Criteria:

Self-reported uncontrolled severe exercise-induced breathlessness

Required a course of antibiotics or oral corticosteroids within the 4 weeks prior to the study commencing

Children with severe co-morbidities that will not allow them to participate in an exercise programme e.g. Severe neuromuscular disorders, recent fractures or surgeries, cognitive or behavioural conditions.

Participant is unable or unwilling, in the opinion of the investigator, to give informed consent

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: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Group 1- usual care
Participants will continue to receive usual care from their asthma team/ provider
Active Comparator: Group 2- education
Participants will receive a 12 week education class on exercise
Other: education
education on exercise and asthma
Active Comparator: Group 3- exercise
Participants will take part in a 12 week interval exercise class
Other: education
education on exercise and asthma
Other: EXERCISE TRAINING WITH OR WITHOUT MEDICATION
12 week interval exercise training programme and 12 week education on exercise with asthma
Other Names:
  • exercise

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Recruitment
Time Frame: 12 weeks
The percentage of children approached who participate in the intervention (recruitment)
12 weeks
Retention
Time Frame: 12 weeks
The percentage of participants that complete the intervention with a retention rate of >70%
12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adherence to programme
Time Frame: 12 weeks
Participant engagement measured through attendance rates.
12 weeks
Wrist worn accelerometers
Time Frame: 12 weeks
Device wear time compliance during the 12-week study, aiming for =>10 hours a day
12 weeks
Focus groups on patients experience to barriers to an exercise programme
Time Frame: 12 weeks
Lived experience of the barriers for children with asthma to taking part in an exercise programme, measured through qualitative focus groups.
12 weeks
Health beliefs
Time Frame: 12 weeks
Baseline demographics from participants will be recorded from medical records
12 weeks
Respiratory (throat) samples
Time Frame: Baseline, 12 weeks, 6 months and 1 year.
Throat samples will be taken and microbial analysis for assessing microbial diversity through 16S rRNA sequencing, to provide relative abundance of bacterial groups. A greater bacterial diversity in the respiratory sample is considered a sign of heathier and more resilient microbial community. This could lead to fewer asthma exacerbations and better asthma control.
Baseline, 12 weeks, 6 months and 1 year.
Quality of life of participants using the paeditric quality of life inventory (asthma module)
Time Frame: Baseline, 12 weeks, 6 months and 1 year
Measured through the paediatric quality of life asthma module to measure how asthma affects the health-related quality of life using 28 items divided into 4 domains, higher scores mean better quality of life and lower scores mean greater asthma-related impairment.
Baseline, 12 weeks, 6 months and 1 year
Effectiveness of the programme
Time Frame: Baseline, 12 weeks, 6 months and 1 year.
Cardiorespiratory fitness (maximal oxygen uptake measured by VO2 max)
Baseline, 12 weeks, 6 months and 1 year.
Respiratory (nasal) samples
Time Frame: Baseline, 12 weeks, 6 months and 1 year.
Nasal samples will be taken and microbial analysis for assessing microbial diversity through 16S rRNA sequencing, to provide relative abundance of bacterial groups. A greater bacterial diversity in the respiratory sample is considered a sign of a heathier and more resilient microbial community. This could lead to fewer asthma exacerbations and better asthma control.
Baseline, 12 weeks, 6 months and 1 year.
Gut samples
Time Frame: Baseline, 12 weeks, 6 months and 1 year.
Stool samples will be taken and microbial analysis for assessing microbial diversity through 16S rRNA sequencing, to provide relative abundance of bacterial groups. A greater bacterial diversity in the stool sample is considered a sign of heathier and more resilient microbial community which could lead to fewer asthma exacerbations and better asthma control.
Baseline, 12 weeks, 6 months and 1 year.
Focus groups on motivators for an exercise programme
Time Frame: 12 weeks
Lived experience of the motivators for children and young people with asthma to taking part in an exercise programme, measured through qualitative focus groups.
12 weeks

Collaborators and Investigators

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

Sponsor

University of Leicester

Collaborators

University Hospitals, Leicester

Investigators

  • Principal Investigator: Erol Gaillard, University of Leicester

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)

July 1, 2026

Primary Completion (Estimated)

June 1, 2029

Study Completion (Estimated)

September 1, 2030

Study Registration Dates

First Submitted

May 10, 2026

First Submitted That Met QC Criteria

June 9, 2026

First Posted (Actual)

June 11, 2026

Study Record Updates

Last Update Posted (Actual)

June 11, 2026

Last Update Submitted That Met QC Criteria

June 9, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1068

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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.

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