Active Airways for Children and Young People With Asthma
The Feasibility of an Exercise and Asthma Educational Programme 'Active Airways' on Health Outcomes in Children and Young People With Asthma With All Severities
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.
研究概览
详细说明
研究类型
注册 (估计的)
阶段
- 不适用
联系人和位置
学习联系方式
- 姓名：Naomi Dayman
- 电话号码：07487506547
- 邮箱：nad21@leicester.ac.uk
学习地点
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-
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Leicester、英国
- University of Leicester
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接触：
- Naomi Dayman
- 电话号码：07487506547
- 邮箱：nad21@leicester.ac.uk
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-
参与标准
资格标准
适合学习的年龄
- 孩子
接受健康志愿者
描述
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
学习计划
研究是如何设计的？
设计细节
- 主要用途：预防
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
无干预：Group 1- usual care
Participants will continue to receive usual care from their asthma team/ provider
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有源比较器：Group 2- education
Participants will receive a 12 week education class on exercise
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education on exercise and asthma
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有源比较器：Group 3- exercise
Participants will take part in a 12 week interval exercise class
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education on exercise and asthma
12 week interval exercise training programme and 12 week education on exercise with asthma
其他名称：
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Recruitment
大体时间：12 weeks
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The percentage of children approached who participate in the intervention (recruitment)
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12 weeks
|
|
Retention
大体时间：12 weeks
|
The percentage of participants that complete the intervention with a retention rate of >70%
|
12 weeks
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Adherence to programme
大体时间：12 weeks
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Participant engagement measured through attendance rates.
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12 weeks
|
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Wrist worn accelerometers
大体时间：12 weeks
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Device wear time compliance during the 12-week study, aiming for =>10 hours a day
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12 weeks
|
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Focus groups on patients experience to barriers to an exercise programme
大体时间：12 weeks
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Lived experience of the barriers for children with asthma to taking part in an exercise programme, measured through qualitative focus groups.
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12 weeks
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Health beliefs
大体时间：12 weeks
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Baseline demographics from participants will be recorded from medical records
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12 weeks
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Respiratory (throat) samples
大体时间：Baseline, 12 weeks, 6 months and 1 year.
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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.
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Baseline, 12 weeks, 6 months and 1 year.
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Quality of life of participants using the paeditric quality of life inventory (asthma module)
大体时间：Baseline, 12 weeks, 6 months and 1 year
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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.
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Baseline, 12 weeks, 6 months and 1 year
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Effectiveness of the programme
大体时间：Baseline, 12 weeks, 6 months and 1 year.
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Cardiorespiratory fitness (maximal oxygen uptake measured by VO2 max)
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Baseline, 12 weeks, 6 months and 1 year.
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Respiratory (nasal) samples
大体时间：Baseline, 12 weeks, 6 months and 1 year.
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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.
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Baseline, 12 weeks, 6 months and 1 year.
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Gut samples
大体时间：Baseline, 12 weeks, 6 months and 1 year.
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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.
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Baseline, 12 weeks, 6 months and 1 year.
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Focus groups on motivators for an exercise programme
大体时间：12 weeks
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Lived experience of the motivators for children and young people with asthma to taking part in an exercise programme, measured through qualitative focus groups.
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12 weeks
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合作者和调查者
调查人员
- 首席研究员：Erol Gaillard、University of Leicester
研究记录日期
研究主要日期
学习开始 (估计的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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