The Effect of Physiotherapy on Dysfunctional Breathing in Children and Adolescents With and Without Asthma.
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 140
- 试验地点
- 2
- 主要终点
- Change from baseline in Pediatric Quality of Life Inventory ( PedsQl) at 6 months
研究概览
简要总结
The purpose of the study is to investigate the effect of physiotherapeutical instructions on dysfunctional breathing in children and adolescents with or without asthma.
Children and adolescents with dysfunctional breathing, are invited to participate in the intervention study. Participants are stratified by asthma diagnose status and randomized to physiotherapy or standard care. Participants are followed a year after the intervention, to compare the development in asthma control ( if asthma) and quality of life.
详细描述
The purpose of the study is to investigate the effect of physiotherapeutical instructions on dysfunctional breathing in children and adolescents with or without asthma.
All children and adolescents aged 10-17 years, followed in our outpatient clinic with the diagnose of asthma are invited to fulfill the Nijmegen Questionnaire (NQ) and the Asthma Control Questionnaire (ACQ5)
Children and adolescents where asthma was investigated and ruled out are invited to fulfill the NQ.
Data from the electronic patient journal are used as descriptives.
Participants with dysfunctional breathing (NQ >= 23) are invited to participate in the intervention study. Participants are stratified by asthma diagnose status and randomized to physiotherapy or standard care. Participants are followed a year after the intervention, to compare the development in asthma control measured by ACQ5 (if asthma) and quality of life measured by PedsQL.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 10 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Asthma group:
- •Asthma diagnosed by lung function tests and/or typical symptoms.
- •Treatment with inhaled corticosteroids in minimum 3 months.
- •ACQ5 >= 1.
- •NonAsthma group
- •Asthma denied after lung function tests ( exercise challenge or mannitol challenge)
- •NQ >= 23.
排除标准
- •Other significant cardiopulmonary or muscoluskeletal conditions.
- •Complex functional conditions involving other organ systems.
- •patients who already had the physotherapeutical intervention before study start.
结局指标
主要结局
Change from baseline in Pediatric Quality of Life Inventory ( PedsQl) at 6 months
时间窗: PedsQL is taken at baseline and 6 months after intervention as primary outcome.
PedsQl consists of 23 questions in 4 segments ( physical functioning, emotions, social interaction, and school activities). Each question is scored from 0 (best) to 4 (worst). The PedsQl questionnairre exists in formats for young children ( not used here), children aged 8-12 years and Teenagers aged 13-18 years. Children and adolescents are answering the age relevant questionnairre at visits in the out patient clinic. The PedsQl score is transformed to a 0-100 scale as follows: 0 =100, 1=75, 2=50, 3=25, 4=0. Health related Quality of life is calculated as a mean of scores. Psychosocial Health summary score is calculated as a mean of scores in the emotional, social and school functioning scales. Physical Health summary score is calculated as physical functioning scale score mean.
Change from baseline in Asthma Control Questionnaire ( ACQ5) at 6 months.
时间窗: ACQ is taken at baseline and 6 months after intervention as primary outcome.
ACQ5 contains 5 questions regarding asthma symptoms. Each question is scored between 0-6 points, where 0 represents very good asthma control and 6 represents poor asthma control. Total ACQ score is calculates as an average of points. ACQ5 is taken by participants with asthma, at visits in the outpatient clinic.
次要结局
- Change from baseline in Pediatric Quality of Life Inventory ( PedsQl) at at 6 weeks and one year. Change from 6 months in PedsQl at 12 months.(PedsQl is taken at 6 weeks and 12 months after intervention as secondary outcomes.)
- The reported use of rescue Beta2 agonist in puffs per week(at baseline and 6 weeks, 6 months and 12 months after intervention.)
- Change from baseline in Brompton breathing Pattern Assesment Tool ( BBPAT)(BBPAT is taken at baseline and 6 weeks, 6 months and 12 months after intervention.)
- Number of contacts to the hospital during one year from baseline(from baseline to 12 months after intervention.)
- Change from baseline in Asthma Control Questionnaire ( ACQ5) at 6 weeks and one year. Change from 6 months in ACQ at 12 months.(ACQ5 is taken at 6 weeks and 12 months after intervention as secondary outcomes.)
- Change from baseline in Nijmegen Questionnaire ( NQ)(NQ is taken at baseline and 6 weeks, 6 months and 12 months after intervention.)
研究者
Signe Vahlkvist
Principal Investigator
Kolding Sygehus