Effectiveness of Anthroposophic Speech Therapy in Patients With Asthma

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Effectiveness of Anthroposophic Therapeutic Speech in Patients With Asthma in a Real-life Outpatient Setting - a Randomised, Controlled, Multicentre Cross-over Trial

Conditions
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Asthma

Intervention / Treatment
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* Other: anthroposophic therapeutic speech


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 COPD Coronary heart disease Oral corticosteroids Pregnancy

Ages Eligible for Study
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Minimum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: speech therapy first<br>11 sessions of speech therapy (anthroposophic therapeutic speech), then waiting phase | Other: anthroposophic therapeutic speech<br>* anthroposophic therapeutic speech<br>|
| Experimental: speech therapy second<br>10 weeks of waiting, then 11 sessions of speech therapy (anthroposophic therapeutic speech) | Other: anthroposophic therapeutic speech<br>* anthroposophic therapeutic speech<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in Asthma Quality of Life Questionnaire |  | 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Measured with peak flow meter | Daily until study end, expected to be 24 weeks | 
| Days without asthma exacerbation |  | Daily until study end, expected to be 24 weeks | 
| Inhaled corticosteroids in μg according to patient's diary |  | Daily until study end, expected to be 24 weeks |