Effectiveness of Anthroposophic Therapeutic Speech in Patients With Asthma in a Real-life Outpatient Setting - a Randomised, Controlled, Multicentre Cross-over Trial
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 49
- 试验地点
- 2
- 主要终点
- Change from baseline in Asthma Quality of Life Questionnaire
研究概览
简要总结
Anthroposophic therapeutic speech is a complementary method that indirectly influences breathing and uses specific vowels, consonants, syllables and metres depending on the indication. The aim of this study is to test the effectiveness of anthroposophic therapeutic speech in patients with asthma regarding clinical and physiological parameters, asthma control and quality of life.
详细描述
Background
Breathing retraining techniques receive increased attention in the management of asthma, since the evidence for safety and usefulness of such procedures is growing. Physiotherapist-guided breathing programs, such as the Papworth method and the Buteyko method, are most systematically investigated and hence yield the best evidence of effectiveness.
Active breathing modulation techniques are frequently assigned to complementary and alternative medicine CAM, comprising of a variety of systems and modalities other than the politically dominant healthcare system.
However, patients may take a different perspective, since the prevalence of CAM use in the treatment of asthma is at a level of 20-30% among adults and 50 - 60% for children, even if rigorous estimates are being applied.
Anthroposophic therapeutic speech applies sounds and syllabic rhythm, e.g. the hexameter, for improving articulation, breathing and cardiorespiratory interaction. The method has been used for many years as a breathing retraining method for asthma in all settings. This study is the first to systematically investigate the effects of ATS in asthma patients in a real-life outpatient setting.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed informed consent
- •Age ≥ 12 years
- •Asthma ≥ 1 year
- •Inhaling β2 agonist ≥ once weekly
- •Exclusion Criteria
- •Not willing to perform therapy actively
- •Insufficient general condition for active therapy
- •Coronary heart disease
- •Oral corticosteroids
- •Pregnancy
排除标准
- 未提供
结局指标
主要结局
Change from baseline in Asthma Quality of Life Questionnaire
时间窗: 24 weeks
次要结局
- Inhaled corticosteroids in μg according to patient's diary(Daily until study end, expected to be 24 weeks)
- Change from baseline in spirometry(12 weeks and 24 weeks)
- Asthma Control Test(Every 4 weeks until study end, expected to be 24 weeks)
- Peak expiratory flow in L/min(Daily until study end, expected to be 24 weeks)
- Days without asthma exacerbation(Daily until study end, expected to be 24 weeks)