Buteyko Method for Children With Asthma: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Change in Quality of life (questionnaire)
研究概览
简要总结
This study has the aim to assess the effectiveness of the Buteyko method as an adjunct therapy in the treatment of children with asthma.
详细描述
Children from 7 to 12 years old with asthma diagnose will be included. Children in the intervention group will perform 6 sessions (twice a week) of treatment with the Buteyko Method. Children assigned to the control group will receive, along with their parents, educational interventions in relation to asthma. The investigators will assess quality of life by the PAQLQ (Paediatric Asthma Quality of Life Questionnaire), pulmonary function (spirometry) and the six-minute walk test. Vital signs, pulmonary auscultation and oxygen peripheral saturation will also be assessed during the tests. In addition, information will be collected on the numbers of hospitalizations, occurence of absence in school due to exacerbation of the disease, asthma symptoms and Beta2-agonists usage .
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 7 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children from 7 up to 12 years old with asthma diagnose;
- •Regular inhaled corticosteroids with no change in dose in the preceding 4 weeks;
- •Children cannot present: other respiratory disease (such as cystic fibrosis, bronchiectasis, tuberculosis), retinal detachment, hypertensive crisis, congenital heart defect, pulmonary edema, history of lobectomy or lung segmentectomy, respiratory infections 15 days prior to the evaluations.
排除标准
- •Children that are not able to perform some of the necessary procedures;
- •Give up participating in the research and present acute symptoms of respiratory tract during the assessments.
研究组 & 干预措施
Buteyko
Children in the intervention group will perform 6 sessions (twice a week) of treatment with the Buteyko Method.
干预措施: Buteyko (Other)
Asthma education
Children assigned to the control group will receive, along with their parents, educational interventions in relation to asthma.
干预措施: Asthma education (Other)
结局指标
主要结局
Change in Quality of life (questionnaire)
时间窗: Baseline and three weeks later
Quality of life will be assessed by the Pediatric Asthma Quality of Life Questionnaire (PAQLQ).
次要结局
- Occurrence of absences in school(Through study completion, an average of three weeks)
- Change in pulmonary function (spirometry)(Baseline and three weeks later)
- Change in the Six-minute walk test distance(Baseline and three weeks later)
- Number of visits to the emergency room(Through study completion, an average of three weeks)
- Occurrence of exacerbations(Through study completion, an average of three weeks)
- Occurrence of Beta2-agonists usage(Through study completion, an average of three weeks)
研究者
Karla Morganna Pereira Pinto de Mendonça
Principal investigator
Universidade Federal do Rio Grande do Norte