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Completed

NCT Number: NCT02501824

Effectiveness of Anthroposophic Speech Therapy in Patients With Asthma

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.

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Key information

Age range

12 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Institute of Complementary Medicine, University of Bern

Bern, 3012, Switzerland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

anthroposophic therapeutic speech

Other

anthroposophic therapeutic speech

Primary outcomes

  1. Change from baseline in Asthma Quality of Life Questionnaire

    Time frame: 24 weeks

Secondary outcomes

  1. Change from baseline in spirometry

    Time frame: 12 weeks and 24 weeks

  2. Asthma Control Test

    Time frame: Every 4 weeks until study end, expected to be 24 weeks

  3. Peak expiratory flow in L/min

    Time frame: Daily until study end, expected to be 24 weeks

    Measured with peak flow meter

  4. Days without asthma exacerbation

    Time frame: Daily until study end, expected to be 24 weeks

  5. Inhaled corticosteroids in μg according to patient's diary

    Time frame: Daily until study end, expected to be 24 weeks

Sponsors and collaborators

Lead sponsor

University of Bern

Other

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2014
Study completion
2014
First posted
Jul 17, 2015
Registry last updated
Jul 17, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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