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.
연구 개요
상태
상세 설명
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: Naomi Dayman
- 전화번호: 07487506547
- 이메일: nad21@leicester.ac.uk
연구 장소
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Leicester, 영국
- University of Leicester
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연락하다:
- Naomi Dayman
- 전화번호: 07487506547
- 이메일: nad21@leicester.ac.uk
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참여기준
자격 기준
공부할 수 있는 나이
- 어린이
건강한 자원 봉사자를 받아들입니다
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 방지
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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간섭 없음: Group 1- usual care
Participants will continue to receive usual care from their asthma team/ provider
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활성 비교기: 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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활성 비교기: 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
다른 이름들:
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Recruitment
기간: 12 weeks
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The percentage of children approached who participate in the intervention (recruitment)
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12 weeks
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Retention
기간: 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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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Adherence to programme
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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)
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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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공동 작업자 및 조사자
수사관
- 수석 연구원: Erol Gaillard, University of Leicester
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- 1068
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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