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NCT Number: NCT07643753

Active Airways for Children and Young People With Asthma

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.

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Key information

Conditions

Asthma Childhood Asthma Behavior Bronchial Diseases Children Exercise Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Lung Diseases Lung Diseases, Obstructive Motor Activity Respiratory Hypersensitivity Respiratory Tract Diseases

Age range

10 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

EXERCISE TRAINING WITH OR WITHOUT MEDICATION

Other

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

Other names: exercise

Education

Other

education on exercise and asthma

Primary outcomes

  1. Recruitment

    Time frame: 12 weeks

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

  2. Retention

    Time frame: 12 weeks

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

Secondary outcomes

  1. Adherence to programme

    Time frame: 12 weeks

    Participant engagement measured through attendance rates.

  2. Wrist worn accelerometers

    Time frame: 12 weeks

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

  3. 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.

  4. Health beliefs

    Time frame: 12 weeks

    Baseline demographics from participants will be recorded from medical records

  5. 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.

  6. 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.

  7. Effectiveness of the programme

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

    Cardiorespiratory fitness (maximal oxygen uptake measured by VO2 max)

  8. 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.

  9. 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.

  10. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Naomi Dayman

CONTACT

[email protected]

07487506547

Sponsors and collaborators

Lead sponsor

University of Leicester

Other

Collaborators

  • University Hospitals, Leicester

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2029
Study completion
2030
First posted
Jun 11, 2026
Registry last updated
Jun 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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