AsthmaPhase 2NCT02501824
Effectiveness of Anthroposophic Speech Therapy in Patients With Asthma
A Phase 2 study testing anthroposophic therapeutic speech in people with Asthma, run by University of Bern at 1 site in Switzerland.
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. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Asthma
- What is being tested?
- anthroposophic therapeutic speech
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 49 participants
- Where
- 1 siteSwitzerland
- Study dates
- Oct 2010to Nov 2014
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Signed informed consent
- Age ≥ 12 years
- Asthma ≥ 1 year
- Inhaling β2 agonist ≥ once weekly
Who cannot join
- Not willing to perform therapy actively
- Insufficient general condition for active therapy
- COPD
- Coronary heart disease
- Oral corticosteroids
- Pregnancy
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Institute of Complementary Medicine, University of Bern
Bern, 3012
About this study
Official title: Effectiveness of Anthroposophic Therapeutic Speech in Patients With Asthma in a Real-life Outpatient Setting - a Randomised, Controlled, Multicentre Cross-over Trial
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.
Read the 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
- Being tested
- anthroposophic therapeutic speech
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
anthroposophic therapeutic speechOther
anthroposophic therapeutic speech
| Study group | Role | What they receive |
|---|---|---|
| speech therapy first | Experimental | 11 sessions of speech therapy (anthroposophic therapeutic speech), then waiting phase Receives: Other: anthroposophic therapeutic speech |
| speech therapy second | Experimental | 10 weeks of waiting, then 11 sessions of speech therapy (anthroposophic therapeutic speech) Receives: Other: anthroposophic therapeutic speech |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in Asthma Quality of Life Questionnaire
Measured: 24 weeks
Secondary outcomes (5)
Change from baseline in spirometry
Measured: 12 weeks and 24 weeks
Asthma Control Test
Measured: Every 4 weeks until study end, expected to be 24 weeks
Peak expiratory flow in L/min
Measured with peak flow meter
Measured: Daily until study end, expected to be 24 weeks
Days without asthma exacerbation
Measured: Daily until study end, expected to be 24 weeks
Inhaled corticosteroids in μg according to patient's diary
Measured: Daily until study end, expected to be 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2015 (estimated)
- Study startOct 2010
- Primary completionAug 2014
- Study completionNov 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AsthmaStudies of the same condition, open and under way.
- More trials run by University of BernThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Bern
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ursula Wolf, Principal investigator, Institute of Complementary Medicine, University of Bern
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02501824
- Sponsor's protocol ID
- 115/10
- Status last verified
- Jul 2015
- First submitted
- 8 Jul 2015
- Last updated
- 17 Jul 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 29941003
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Anthroposophic Therapeutic Speech in Patients With Asthma in a Real-life Outpatient Setting - a Randomised, Controlled, Multicentre Cross-over Trial
- ClinicalTrials.gov ID
- NCT02501824
- Acronym / sponsor ID
- 115/10
- Conditions
- Asthma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- University of BernUniversity, hospital or other
- Study start
- Oct 2010
- Primary completion
- Aug 2014 (actual)
- Study completion
- Nov 2014 (actual)
- First posted
- 17 Jul 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| speech therapy first | Experimental | Other: anthroposophic therapeutic speech11 sessions of speech therapy (anthroposophic therapeutic speech), then waiting phase |
| speech therapy second | Experimental | Other: anthroposophic therapeutic speech10 weeks of waiting, then 11 sessions of speech therapy (anthroposophic therapeutic speech) |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Signed informed consent
- Age ≥ 12 years
- Asthma ≥ 1 year
- Inhaling β2 agonist ≥ once weekly
Key exclusion criteria (6 listed)
- Not willing to perform therapy actively
- Insufficient general condition for active therapy
- COPD
- Coronary heart disease
- Oral corticosteroids
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| anthroposophic therapeutic speechanthroposophic therapeutic speech | Other | speech therapy first, speech therapy second |
Primary outcome
Change from baseline in Asthma Quality of Life Questionnaire
Time frame: 24 weeks
5 secondary outcomes
Change from baseline in spirometry
Time frame: 12 weeks and 24 weeks
Asthma Control Test
Time frame: Every 4 weeks until study end, expected to be 24 weeks
Peak expiratory flow in L/min
Time frame: Daily until study end, expected to be 24 weeks
Days without asthma exacerbation
Time frame: Daily until study end, expected to be 24 weeks
Inhaled corticosteroids in μg according to patient's diary
Time frame: Daily until study end, expected to be 24 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2015.
- Derived from this study: PubMed 29941003von 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ursula Wolf principal investigator
Institute of Complementary Medicine, University of Bern
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing anthroposophic therapeutic speech in people with Asthma, run by University of Bern at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in Asthma Quality of Life Questionnaire (time frame: 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02501824, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jul 2015.