Efficacy of the Combination of General Relaxation (Mindfulness) and Respiratory (Buteyko) Techniques for the Improvement of Poorly Controlled Asthma. The MBA Study
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Changes in asthma exacerbation
研究概览
简要总结
Administration of a combined program for general (Mindfulness) and respiratory (Buteyko technique) relationship in patients with poorly controlled asthma and anxiety/stress to determine if it provides an improvement in current control and future risk of asthma.
详细描述
A Mindfulness relaxation program and a Buteyko technique respiratory rehabilitation program will be administered individually and weekly, in 10 sessions (5 face-to-face and 5 telematic sessions afterwards). Patients will be visited 4 times (at inclusion, one month, 6 months and 12 months after the double intervention), where data on asthmatic morbidity, pulmonary function (spirometry), bronchial inflammation (FENO) will be collected and some questionnaires will be administered.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of poorly controlled asthma
- •In treatment with a combination of ICS/LABA at medium doses
- •Anxiety and/or functional dyspnea
- •Attended in the outpatient consultations of the Asthma Unit of the Pneumology and Allergy Service of the Hospital de la Santa Creu i Sant Pau in Barcelona
排除标准
- •Severe asthma exacerbation in the last 30 days
- •Severe disabling comorbidity
- •Severe psychiatric illness
- •Inability to complete questionnaires.
研究组 & 干预措施
Mindfulness and Buteyko techniques
A Mindfulness relaxation program and a Buteyko technique respiratory rehabilitation program will be administered individually and weekly, in 10 sessions (5 face-to-face and 5 telematic sessions afterwards).
干预措施: Mindfulness and Buteyko techniques (Other)
结局指标
主要结局
Changes in asthma exacerbation
时间窗: 1 year
Changes in asthma exacerbation measured by number of hospital admissions and medical treatments received
% patients with changed asthma control
时间窗: 1 year
Changes in asthma symptoms measured with the asthma control test (minimum 5 as worse value; maximum 25, as the best value)
次要结局
- Therapeutic adherence of patients to inhalers(1 year)
- Pulmonary function(1 year)
- Bronchial inflammation(1 year)
- Functional dyspnea(1 year)
- Anxiety(1 year)