Asthma Childhood, Children, Exercise
Conditions
Keywords
asthma, children, exercise, physical activity
Brief 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.
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
OTHEREXERCISE TRAINING WITH OR WITHOUT MEDICATION
12 week interval exercise training programme and 12 week education on exercise with asthma
OTHEReducation
education on exercise and asthma
Sponsors
University of Leicester
University Hospitals, Leicester
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Intervention model description
There are three groups for the active airways study: Group 1- usual care Group 2- education only Group 3- exercise and education programme
Eligibility
Sex/Gender
ALL
Age
10 Years to 17 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Recruitment | 12 weeks | The percentage of children approached who participate in the intervention (recruitment) |
| Retention | 12 weeks | The percentage of participants that complete the intervention with a retention rate of \>70% |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Adherence to programme | 12 weeks | Participant engagement measured through attendance rates. |
| Wrist worn accelerometers | 12 weeks | Device wear time compliance during the 12-week study, aiming for =\>10 hours a day |
| Focus groups on patients experience to barriers to an exercise programme | 12 weeks | Lived experience of the barriers for children with asthma to taking part in an exercise programme, measured through qualitative focus groups. |
| Health beliefs | 12 weeks | Baseline demographics from participants will be recorded from medical records |
| Respiratory (throat) samples | 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. |
| Quality of life of participants using the paeditric quality of life inventory (asthma module) | 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. |
| Effectiveness of the programme | Baseline, 12 weeks, 6 months and 1 year. | Cardiorespiratory fitness (maximal oxygen uptake measured by VO2 max) |
| Respiratory (nasal) samples | 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. |
| Gut samples | 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. |
| Focus groups on motivators for an exercise programme | 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. |
Countries
United Kingdom
Contacts
CONTACTNaomi Dayman
PRINCIPAL_INVESTIGATORErol Gaillard
University of Leicester
Outcome results
None listed