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Effectiveness of Anthroposophic Speech Therapy in Patients With Asthma

Primary Purpose

Asthma

Status
Completed
Phase
Phase 2
Locations
Switzerland
Study Type
Interventional
Intervention
anthroposophic therapeutic speech
Sponsored by
University of Bern
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Asthma

Eligibility Criteria

12 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Institute of Complementary Medicine, University of Bern

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

speech therapy first

speech therapy second

Arm Description

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

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

Outcomes

Primary Outcome Measures

Change from baseline in Asthma Quality of Life Questionnaire

Secondary Outcome Measures

Change from baseline in spirometry
Asthma Control Test
Peak expiratory flow in L/min
Measured with peak flow meter
Days without asthma exacerbation
Inhaled corticosteroids in μg according to patient's diary

Full Information

First Posted
July 8, 2015
Last Updated
July 15, 2015
Sponsor
University of Bern
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1. Study Identification

Unique Protocol Identification Number
NCT02501824
Brief Title
Effectiveness of Anthroposophic Speech Therapy in Patients With Asthma
Official Title
Effectiveness of Anthroposophic Therapeutic Speech in Patients With Asthma in a Real-life Outpatient Setting - a Randomised, Controlled, Multicentre Cross-over Trial
Study Type
Interventional

2. Study Status

Record Verification Date
July 2015
Overall Recruitment Status
Completed
Study Start Date
October 2010 (undefined)
Primary Completion Date
August 2014 (Actual)
Study Completion Date
November 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Bern

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
49 (Actual)

8. Arms, Groups, and Interventions

Arm Title
speech therapy first
Arm Type
Experimental
Arm Description
11 sessions of speech therapy (anthroposophic therapeutic speech), then waiting phase
Arm Title
speech therapy second
Arm Type
Experimental
Arm Description
10 weeks of waiting, then 11 sessions of speech therapy (anthroposophic therapeutic speech)
Intervention Type
Other
Intervention Name(s)
anthroposophic therapeutic speech
Intervention Description
anthroposophic therapeutic speech
Primary Outcome Measure Information:
Title
Change from baseline in Asthma Quality of Life Questionnaire
Time Frame
24 weeks
Secondary Outcome Measure Information:
Title
Change from baseline in spirometry
Time Frame
12 weeks and 24 weeks
Title
Asthma Control Test
Time Frame
Every 4 weeks until study end, expected to be 24 weeks
Title
Peak expiratory flow in L/min
Description
Measured with peak flow meter
Time Frame
Daily until study end, expected to be 24 weeks
Title
Days without asthma exacerbation
Time Frame
Daily until study end, expected to be 24 weeks
Title
Inhaled corticosteroids in μg according to patient's diary
Time Frame
Daily until study end, expected to be 24 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ursula Wolf
Organizational Affiliation
Institute of Complementary Medicine, University of Bern
Official's Role
Principal Investigator
Facility Information:
Facility Name
Institute of Complementary Medicine, University of Bern
City
Bern
ZIP/Postal Code
3012
Country
Switzerland

12. IPD Sharing Statement

Citations:
PubMed Identifier
29941003
Citation
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.
Results Reference
derived

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Effectiveness of Anthroposophic Speech Therapy in Patients With Asthma

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