Effectiveness of Anthroposophic Speech Therapy in Patients With Asthma

NCT ID: NCT02501824

Last Updated: 2015-07-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 49 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-10-31
• Study Completion Date: 2014-11-30

Brief 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.

Detailed 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.

Conditions

Asthma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

speech therapy first

11 sessions of speech therapy (anthroposophic therapeutic speech), then waiting phase

Group Type: EXPERIMENTAL

anthroposophic therapeutic speech

Intervention Type: OTHER

anthroposophic therapeutic speech

speech therapy second

10 weeks of waiting, then 11 sessions of speech therapy (anthroposophic therapeutic speech)

Group Type: EXPERIMENTAL

anthroposophic therapeutic speech

Intervention Type: OTHER

anthroposophic therapeutic speech

Interventions

anthroposophic therapeutic speech

anthroposophic therapeutic speech

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Bern

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ursula Wolf

Role: PRINCIPAL_INVESTIGATOR

Institute of Complementary Medicine, University of Bern

Locations

Institute of Complementary Medicine, University of Bern

Bern, , Switzerland

Countries

Switzerland

References

von Bonin D, Klein SD, Wurker J, Streit E, Avianus O, Grah C, Salomon J, Wolf U. Speech-guided breathing retraining in asthma: a randomised controlled crossover trial in real-life outpatient settings. Trials. 2018 Jun 25;19(1):333. doi: 10.1186/s13063-018-2727-z.

Reference Type: DERIVED

PMID: 29941003 (View on PubMed)

Other Identifiers

115/10

Identifier Type: -

Identifier Source: org_study_id