Asthma Clinical Trial
Official title:
Effectiveness of Anthroposophic Therapeutic Speech in Patients With Asthma in a Real-life Outpatient Setting - a Randomised, Controlled, Multicentre Cross-over Trial
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.
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.
Objective
The following hypotheses are tested: i) anthroposophic therapeutic speech improves relevant
parameters of pulmonary function in patients with asthma. ii) anthroposophic therapeutic
speech reduces the use of as-needed medication in patients with asthma. iii) anthroposophic
therapeutic speech improves asthma control and quality of life in patients with asthma.
Methods
The study is a randomised, controlled, multicentre, 2-period cross-over clinical trial
conducted at 3 centres in Switzerland and Germany. Participants are randomly assigned in a
1:1 allocation ratio to either firstly receive 11 speech therapy sessions or to wait
(control), followed by a cross-over to the other group.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
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