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
About this trial
This is an interventional treatment trial for Asthma
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
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
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
Learn more about this trial
Effectiveness of Anthroposophic Speech Therapy in Patients With Asthma
We'll reach out to this number within 24 hrs