ClinicalTrials.gg
Not yet recruitingNCT07643753Updated Jun 11, 2026

Active Airways for Children and Young People With Asthma

An interventional study of EXERCISE TRAINING WITH OR WITHOUT MEDICATION and education in Asthma Childhood, Exercise and Children, sponsored by University of Leicester. Not yet recruiting at 1 site in United Kingdom. Open to participants aged 10 Years to 17 Years. Per ClinicalTrials.gov, last updated 2026-06-11.

Primary conditionAsthmaRegistry: Motor ActivityReclassifiedWhy we changed it
Registry
Motor Activity — the first condition term the registry derived for this study.
ClinicalTrials.gg
Asthma
Why
  1. Motor Activity is a broad heading, used only when no more specific condition is named.
  2. The study's listed conditions name Asthma.
Confidence
High: the new condition is named in the study's own listed conditions. Of 351 hand-checked studies reclassified this way, 68% were exactly right and 84% in the right disease family; the registry's first term was right for 5% (measured 2026-10-21). How we classify →
Wrong?
Tell us the study's main condition →

Sponsored by University of Leicester · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
10 Years to 17 Years
Sex
All
01

Study summary

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.

Read the 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.

02

Conditions studied

  • Asthma Childhood
  • Exercise
  • Children

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Keywords

  • asthma
  • children
  • exercise
  • physical activity
03

In context

Asthma Reclassified

4,841 studies on the registry are indexed under Asthma; 600 are open to participants now.

This study's planned enrollment of 60 is below the median of 78 across 3,341 interventional studies indexed under Asthma.

Browse Asthma studies →

Lead sponsor

University of Leicester is the lead sponsor of 170 studies on the registry; 51 are open to participants now.

Compared within Asthma, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Motor Activity. The counts are of registry records indexed under each term, refreshed daily. How we classify →

04

Who can participate

Ages eligible
10 Years to 17 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

Self-reported uncontrolled severe exercise-induced breathlessness

Required a course of antibiotics or oral 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

Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
60 participants (estimated)

Study arms

  • 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

  • Active comparator
    Group 3- exercise

    Participants will take part in a 12 week interval exercise class

    Other: EXERCISE TRAINING WITH OR WITHOUT MEDICATION · Other: education

Interventions

  • OtherEXERCISE TRAINING WITH OR WITHOUT MEDICATION

    12 week interval exercise training programme and 12 week education on exercise with asthma

    Also known as: exercise

  • Othereducation

    education on exercise and asthma

06

What researchers measure

Primary outcomes

  1. Recruitment

    The percentage of children approached who participate in the intervention (recruitment)

    Time frame: 12 weeks

  2. Retention

    The percentage of participants that complete the intervention with a retention rate of \>70%

    Time frame: 12 weeks

Secondary outcomes

  1. Adherence to programme

    Participant engagement measured through attendance rates.

    Time frame: 12 weeks

  2. Wrist worn accelerometers

    Device wear time compliance during the 12-week study, aiming for =\>10 hours a day

    Time frame: 12 weeks

  3. Focus groups on patients experience to barriers to an exercise programme

    Lived experience of the barriers for children with asthma to taking part in an exercise programme, measured through qualitative focus groups.

    Time frame: 12 weeks

  4. Health beliefs

    Baseline demographics from participants will be recorded from medical records

    Time frame: 12 weeks

  5. Respiratory (throat) samples

    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.

    Time frame: Baseline, 12 weeks, 6 months and 1 year.

  6. Quality of life of participants using the paeditric quality of life inventory (asthma module)

    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.

    Time frame: Baseline, 12 weeks, 6 months and 1 year

  7. Effectiveness of the programme

    Cardiorespiratory fitness (maximal oxygen uptake measured by VO2 max)

    Time frame: Baseline, 12 weeks, 6 months and 1 year.

  8. Respiratory (nasal) samples

    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.

    Time frame: Baseline, 12 weeks, 6 months and 1 year.

  9. Gut samples

    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.

    Time frame: Baseline, 12 weeks, 6 months and 1 year.

  10. Focus groups on motivators for an exercise programme

    Lived experience of the motivators for children and young people with asthma to taking part in an exercise programme, measured through qualitative focus groups.

    Time frame: 12 weeks

07

Study locations

1 site
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 11, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07643753
Collaborators
University Hospitals, Leicester
Responsible party
Sponsor
First posted
Jun 11, 2026
Start date
Jul 2026 (estimated)
Primary completion
Jun 2029 (estimated)
Completion
Sep 2030 (estimated)
Last update
Jun 11, 2026

Study contacts

Naomi Dayman
Contact
nad21@leicester.ac.uk
07487506547
Erol Gaillard
principal investigator · University of Leicester

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in May 2026. You cannot join it, but the record below documents what was studied.

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