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| Name | Class |
|---|---|
| University Hospitals, Leicester | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1- usual care | No Intervention | Participants will continue to receive usual care from their asthma team/ provider | |
| Group 2- education | Active Comparator | Participants will receive a 12 week education class on exercise |
|
| Group 3- exercise | Active Comparator | Participants will take part in a 12 week interval exercise class |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EXERCISE TRAINING WITH OR WITHOUT MEDICATION | Other | 12 week interval exercise training programme and 12 week education on exercise with asthma |
|
| Measure | Description | Time Frame |
|---|---|---|
| Recruitment | The percentage of children approached who participate in the intervention (recruitment) | 12 weeks |
| Retention | The percentage of participants that complete the intervention with a retention rate of >70% | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Adherence to programme | Participant engagement measured through attendance rates. | 12 weeks |
| Wrist worn accelerometers | Device wear time compliance during the 12-week study, aiming for =>10 hours a day |
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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
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Naomi Dayman | Contact | 07487506547 | nad21@leicester.ac.uk |
| Name | Affiliation | Role |
|---|---|---|
| Erol Gaillard | University of Leicester | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Leicester | Leicester | United Kingdom |
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| ID | Term |
|---|---|
| D009043 | Motor Activity |
| D001249 | Asthma |
| ID | Term |
|---|---|
| D001519 | Behavior |
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
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| ID | Term |
|---|---|
| D015444 | Exercise |
| D004304 | Dosage Forms |
| D004522 | Educational Status |
| ID | Term |
|---|---|
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
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There are three groups for the active airways study:
Group 1- usual care Group 2- education only Group 3- exercise and education programme
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| education | Other | education on exercise and asthma |
|
| 12 weeks |
| 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. | 12 weeks |
| Health beliefs | Baseline demographics from participants will be recorded from medical records | 12 weeks |
| 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. | Baseline, 12 weeks, 6 months and 1 year. |
| 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. | Baseline, 12 weeks, 6 months and 1 year |
| Effectiveness of the programme | Cardiorespiratory fitness (maximal oxygen uptake measured by VO2 max) | Baseline, 12 weeks, 6 months and 1 year. |
| 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. | Baseline, 12 weeks, 6 months and 1 year. |
| 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. | Baseline, 12 weeks, 6 months and 1 year. |
| 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. | 12 weeks |
| D008171 |
| Lung Diseases |
| D012130 | Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D004364 | Pharmaceutical Preparations |
| D013678 | Technology, Pharmaceutical |
| D008919 | Investigative Techniques |
| D012959 | Socioeconomic Factors |
| D011154 | Population Characteristics |