Active Airways for Children and Young People With Asthma
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: EXERCISE TRAINING WITH OR WITHOUT MEDICATION, education.
- Who it may be relevant to
- Registry conditions: Asthma Childhood, Exercise, Children. Basic parameters: 10 years — 17 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United Kingdom
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official 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
Overview
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.
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.
Interventions
- Other EXERCISE TRAINING WITH OR WITHOUT MEDICATION
12 week interval exercise training programme and 12 week education on exercise with asthma - Other education
education on exercise and asthma
Primary outcome measures
- Recruitment [Time frame: 12 weeks]
- Retention [Time frame: 12 weeks]
Secondary outcome measures (10)
- Adherence to programme [Time frame: 12 weeks]
- Wrist worn accelerometers [Time frame: 12 weeks]
- Focus groups on patients experience to barriers to an exercise programme [Time frame: 12 weeks]
- Health beliefs [Time frame: 12 weeks]
- Respiratory (throat) samples [Time frame: 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]
- Effectiveness of the programme [Time frame: Baseline, 12 weeks, 6 months and 1 year.]
- Respiratory (nasal) samples [Time frame: Baseline, 12 weeks, 6 months and 1 year.]
- Gut samples [Time frame: Baseline, 12 weeks, 6 months and 1 year.]
- Focus groups on motivators for an exercise programme [Time frame: 12 weeks]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Prevention
Study locations
United Kingdom · 1 center
- University of Leicester — Leicester
Identifiers
NCT: NCT07643753 · 1068