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临床试验/NCT02724657
NCT02724657已完成不适用

THE EFFECTS OF THE BUTEYKO METHOD IN MOUTH BREATHING ASTHMATIC CHILDREN: A CONTROLLED RANDOMIZED STUDY

Universidade Federal do Rio Grande do Norte2 个研究点 分布在 1 个国家目标入组 35 人开始时间: 2016年3月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
35
试验地点
2
主要终点
Change in Sleep disturbance (questionnaire)

研究概览

简要总结

To assess the effectiveness of the Buteyko method as an adjunct therapy in the treatment of asthmatic children with mouth breathing.

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

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, and 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.

结局指标

主要结局

Change in Sleep disturbance (questionnaire)

时间窗: Baseline, three weeks later and six months after treatment

Sleep disturbance will be assessed by the sleep disturbance scale for children (SDSC).

次要结局

  • Change in spirometry (FVC, FEV1, FEV1/FVC, FEF25-75%, PEF)(Baseline, three weeks later and six months after treatment)
  • Change in ventilometry (minute volume and vital capacity)(Baseline, three weeks later and six months after treatment)
  • Number of hospitalizations(Through study completion, an average of three weeks and six months after treatment)
  • Number of days off-school(During the three weeks of treatment)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Karla Morganna Pereira Pinto de Mendonça

Principal investigator

Universidade Federal do Rio Grande do Norte

研究点 (2)

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