Effectiveness of Anthroposophic Speech Therapy in Patients With Asthma

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02501824
• Other study ID #: 115/10
• Status: Completed
• Phase: Phase 2
• First received: July 8, 2015
• Last updated: July 15, 2015
• Start date: October 2010
• Est. completion date: November 2014

Study information

• Verified date: July 2015
• Source: University of Bern
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Ethikkommission
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 49
• Est. completion date: November 2014
• Est. primary completion date: August 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 12 Years and older

Eligibility

Inclusion Criteria:

• Signed informed consent

• Age = 12 years

• Asthma = 1 year

• Inhaling ß2 agonist = once weekly

Exclusion Criteria

• Not willing to perform therapy actively

• Insufficient general condition for active therapy

• COPD

• Coronary heart disease

• Oral corticosteroids

• Pregnancy

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Asthma

Intervention

Other:
• anthroposophic therapeutic speech
anthroposophic therapeutic speech

Locations

Country	Name	City	State
Switzerland	Institute of Complementary Medicine, University of Bern	Bern

Sponsors (1)

Lead Sponsor	Collaborator
University of Bern

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in Asthma Quality of Life Questionnaire		24 weeks	No
Secondary	Change from baseline in spirometry		12 weeks and 24 weeks	No
Secondary	Asthma Control Test		Every 4 weeks until study end, expected to be 24 weeks	No
Secondary	Peak expiratory flow in L/min	Measured with peak flow meter	Daily until study end, expected to be 24 weeks	No
Secondary	Days without asthma exacerbation		Daily until study end, expected to be 24 weeks	No
Secondary	Inhaled corticosteroids in µg according to patient's diary		Daily until study end, expected to be 24 weeks	No