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.
調査の概要
詳細な説明
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：Naomi Dayman
- 電話番号：07487506547
- メール：nad21@leicester.ac.uk
研究場所
-
-
-
Leicester、イギリス
- University of Leicester
-
コンタクト：
- Naomi Dayman
- 電話番号：07487506547
- メール：nad21@leicester.ac.uk
-
-
参加基準
適格基準
就学可能な年齢
- 子
健康ボランティアの受け入れ
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：防止
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
介入なし：Group 1- usual care
Participants will continue to receive usual care from their asthma team/ provider
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|
|
アクティブコンパレータ：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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アクティブコンパレータ：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
他の名前：
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Recruitment
時間枠：12 weeks
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The percentage of children approached who participate in the intervention (recruitment)
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12 weeks
|
|
Retention
時間枠：12 weeks
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The percentage of participants that complete the intervention with a retention rate of >70%
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12 weeks
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Adherence to programme
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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)
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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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協力者と研究者
スポンサー
捜査官
- 主任研究者：Erol Gaillard、University of Leicester
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- 1068
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
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