AsthmaNCT03098849
Effectiveness of a Buteyko-based Breathing Technique for Asthma Patients
A study testing Buteyko Breathing Technique in people with Asthma, run by ARCIM Institute Academic Research in Complementary and Integrative Medicine at 1 site in Germany.
Trial summary
The purpose of this study is to investigate the effects of a Buteyko-based breathing technique on physiological and psychological parameters in adults with asthma Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Asthma
- What is being tested?
- Buteyko Breathing Technique
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 63 participants
- Where
- 1 siteGermany
- Study dates
- 25 Jan 2017to 26 Oct 2017
- Phase
- Interventional
- 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 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Written informed consent, regular intake of prescribed asthma medication according to the AWMF scheme level 1, native speaker of german
Who cannot join
- Participation in another study, comorbidities (heart diseases, cancer still under treatment, psychiatric diseases)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of a Buteyko-based Breathing Technique on Psycho-physiological Parameters of Adults With Asthma - a Randomized, Controlled Study
The purpose of this study is to investigate the effects of a Buteyko-based breathing technique on physiological and psychological parameters in adults with asthma
Read the detailed description
The investigators explore the effects of a Buteyko-based breathing technique training using a treatment group vs. control group design and a repeated measures design with follow-up measurements 3 and 6 months after the intervention. The sample size calculation was made for an effect of d = .20 with repeated measures, a power of 1- β = .80 and α = .05. Additionally the investigators plan to take measurements (only once) from healthy volunteers matching them (age and gender) with the asthma patients.
- Conditions
- Asthma
- Being tested
- Buteyko Breathing Technique
- Keywords
- Buteyko-based breathing technique training
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Buteyko Breathing TechniqueOther
Patients are trained in various exercises aiming at breath reduction and breath control as introduced by Dr. K. Buteyko
| Study group | Role | What they receive |
|---|---|---|
| Buteyko Training | Experimental | Breathing exercises according to the Buteyko Breathing Technique Receives: Other: Buteyko Breathing Technique |
| Control Group | No intervention | Standard care as usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Endtidal CO2
Capnometry
Measured: Between baseline and 3 month follow up
Change in Nijmegen-Score
Questionnare assessing hyperventilation
Measured: Between baseline and 3 month follow up
Change in Buteyko CP
Breath hold test
Measured: Between baseline and 3 month follow up
Secondary outcomes (44)
Spirometry: FEV1
FEV1
Measured: Between baseline and 3 month follow up
Spirometry: FEV1
FEV1
Measured: Between baseline and 6 month follow up
Spirometry: FEV1/VCin
FEV1/VCin
Measured: Between baseline and 3 month follow up
Spirometry: FEV1/VCin
FEV1/VCin
Measured: Between baseline and 6 month follow up
Spirometry: PEF
PEF
Measured: Between baseline and 3 month follow up
Spirometry: PEF
PEF
Measured: Between baseline and 6 month follow up
Oral exhaled Nitric oxide
Measured: Between baseline and 3 month follow up
Oral exhaled Nitric oxide
Measured: Between baseline and 6 month follow up
Heart Rate Variability (SDNN)
SDNN
Measured: Between baseline and 3 month follow up
Heart Rate Variability (SDNN)
SDNN
Measured: Between baseline and 6 month follow up
Heart Rate Variability (RMSSD)
RMSSD
Measured: Between baseline and 3 month follow up
Heart Rate Variability (RMSSD)
RMSSD
Measured: Between baseline and 6 month follow up
Heart Rate Variability (LF/HF)
LF/HF
Measured: Between baseline and 3 month follow up
Heart Rate Variability (LF/HF)
LF/HF
Measured: Between baseline and 6 month follow up
Vascular stiffness
Pulse Wave Velocity
Measured: Between baseline and 3 month follow up
Vascular stiffness
Pulse Wave Velocity
Measured: Between baseline and 6 month follow up
Blood Pressure
Systolic and Diastolic
Measured: Between baseline and 3 month follow up
Blood Pressure
Systolic and Diastolic
Measured: Between baseline and 6 month follow up
Haemodynamics Stroke volume
Stroke volume
Measured: Between baseline and 3 month follow up
Haemodynamics Stroke volume
Stroke volume
Measured: Between baseline and 6 month follow up
Haemodynamics Cardiac output
Cardiac output
Measured: Between baseline and 3 month follow up
Haemodynamics Cardiac output
Cardiac output
Measured: Between baseline and 6 month follow up
Haemodynamics Total Vascular Resistance
Total Vascular Resistance
Measured: Between baseline and 3 month follow up
Haemodynamics Total Vascular Resistance
Total Vascular Resistance
Measured: Between baseline and 6 month follow up
Haemodynamics Cardiac index
Cardiac index
Measured: Between baseline and 3 month follow up
Haemodynamics Cardiac index
Cardiac index
Measured: Between baseline and 6 month follow up
Haemodynamics Perfusion
Perfusion index
Measured: Between baseline and 3 month follow up
Haemodynamics Perfusion
Perfusion index
Measured: Between baseline and 6 month follow up
Haemodynamics Plethvariability
Plethvariability index (PVI)
Measured: Between baseline and 3 month follow up
Haemodynamics Plethvariability
Plethvariability index (PVI)
Measured: Between baseline and 6 month follow up
Oxygen Saturation
SpO2
Measured: Between baseline and 3 month follow up
Oxygen Saturation
SpO2
Measured: Between baseline and 6 month follow up
ACQ
Asthma Control Questionnaire, E. Juniper
Measured: Between baseline and 3 month follow up
ACQ
Asthma Control Questionnaire, E. Juniper
Measured: Between baseline and 6 month follow up
AQLQ
Asthma Quality of Life Questionnaire, E. Juniper
Measured: Between baseline and 3 month follow up
AQLQ
Asthma Quality of Life Questionnaire, E. Juniper
Measured: Between baseline and 6 month follow up
ARCIM Questionnaire
Questionnaire focusing on respiratory complaints like mucus, snoring, blocked nose.
Measured: Between baseline and 3 month follow up
ARCIM Questionnaire
Questionnaire focusing on respiratory complaints like mucus, snoring, blocked nose.
Measured: Between baseline and 6 month follow up
STAI Questionnaire
State and Trait Anxiety Inventory
Measured: Between baseline and 3 month follow up
STAI Questionnaire
State and Trait Anxiety Inventory
Measured: Between baseline and 6 month follow up
ASF Questionnaire
"Aachener Selbstwirksamkeitsfragebogen"
Measured: Between baseline and 3 month follow up
ASF Questionnaire
"Aachener Selbstwirksamkeitsfragebogen"
Measured: Between baseline and 6 month follow up
Asthma medication
Kind and dosage of asthma specific medication like steroids or betamimetics
Measured: Between baseline and 3 month follow up
Asthma medication
Kind and dosage of asthma specific medication like steroids or betamimetics
Measured: Between baseline and 6 month follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2017
- Study start25 Jan 2017
- Primary completion26 Oct 2017
- Study completion26 Oct 2017
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.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- ARCIM Institute Academic Research in Complementary and Integrative Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital Tuebingen
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03098849
- Sponsor's protocol ID
- RBT_10
- Status last verified
- May 2018
- First submitted
- 10 Mar 2017
- Last updated
- 9 May 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Vagedes K, Kuderer S, Ehmann R, Kohl M, Wildhaber J, Jorres RA, Vagedes J. Effect of Buteyko breathing technique on clinical and functional parameters in adult patients with asthma: a randomized, controlled study. Eur J Med Res. 2024 Jan 11;29(1):42. doi: 10.1186/s40001-023-01634-1.
PubMed 38212823
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of a Buteyko-based Breathing Technique on Psycho-physiological Parameters of Adults With Asthma - a Randomized, Controlled Study
- ClinicalTrials.gov ID
- NCT03098849
- Acronym / sponsor ID
- RBT_10
- Conditions
- Asthma
- Keywords
- Buteyko-based breathing technique training
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- ARCIM Institute Academic Research in Complementary and Integrative MedicineUniversity, hospital or other
- Collaborators
- University Hospital Tuebingen
- Study start
- 25 Jan 2017 (actual)
- Primary completion
- 26 Oct 2017 (actual)
- Study completion
- 26 Oct 2017 (actual)
- First posted
- 4 Apr 2017 (actual)
- 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.
The purpose of this study is to investigate the effects of a Buteyko-based breathing technique on physiological and psychological parameters in adults with asthma
Detailed description
The investigators explore the effects of a Buteyko-based breathing technique training using a treatment group vs. control group design and a repeated measures design with follow-up measurements 3 and 6 months after the intervention. The sample size calculation was made for an effect of d = .20 with repeated measures, a power of 1- β = .80 and α = .05. Additionally the investigators plan to take measurements (only once) from healthy volunteers matching them (age and gender) with the asthma patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Buteyko Training | Experimental | Other: Buteyko Breathing TechniqueBreathing exercises according to the Buteyko Breathing Technique |
| Control Group | No intervention | –Standard care as usual |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Written informed consent, regular intake of prescribed asthma medication according to the AWMF scheme level 1, native speaker of german
Key exclusion criteria (1 listed)
- Participation in another study, comorbidities (heart diseases, cancer still under treatment, psychiatric diseases)
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 |
|---|---|---|
| Buteyko Breathing TechniquePatients are trained in various exercises aiming at breath reduction and breath control as introduced by Dr. K. Buteyko | Other | Buteyko Training |
Primary outcome
Change in Endtidal CO2
Time frame: Between baseline and 3 month follow up
Capnometry
Change in Nijmegen-Score
Time frame: Between baseline and 3 month follow up
Questionnare assessing hyperventilation
Change in Buteyko CP
Time frame: Between baseline and 3 month follow up
Breath hold test
44 secondary outcomes
Spirometry: FEV1
Time frame: Between baseline and 3 month follow up
Spirometry: FEV1
Time frame: Between baseline and 6 month follow up
Spirometry: FEV1/VCin
Time frame: Between baseline and 3 month follow up
Spirometry: FEV1/VCin
Time frame: Between baseline and 6 month follow up
Spirometry: PEF
Time frame: Between baseline and 3 month follow up
Spirometry: PEF
Time frame: Between baseline and 6 month follow up
Time frame: Between baseline and 3 month follow up
Time frame: Between baseline and 6 month follow up
Heart Rate Variability (SDNN)
Time frame: Between baseline and 3 month follow up
Heart Rate Variability (SDNN)
Time frame: Between baseline and 6 month follow up
Heart Rate Variability (RMSSD)
Time frame: Between baseline and 3 month follow up
Heart Rate Variability (RMSSD)
Time frame: Between baseline and 6 month follow up
Heart Rate Variability (LF/HF)
Time frame: Between baseline and 3 month follow up
Heart Rate Variability (LF/HF)
Time frame: Between baseline and 6 month follow up
Vascular stiffness
Time frame: Between baseline and 3 month follow up
Vascular stiffness
Time frame: Between baseline and 6 month follow up
Blood Pressure
Time frame: Between baseline and 3 month follow up
Blood Pressure
Time frame: Between baseline and 6 month follow up
Haemodynamics Stroke volume
Time frame: Between baseline and 3 month follow up
Haemodynamics Stroke volume
Time frame: Between baseline and 6 month follow up
Haemodynamics Cardiac output
Time frame: Between baseline and 3 month follow up
Haemodynamics Cardiac output
Time frame: Between baseline and 6 month follow up
Haemodynamics Total Vascular Resistance
Time frame: Between baseline and 3 month follow up
Haemodynamics Total Vascular Resistance
Time frame: Between baseline and 6 month follow up
Haemodynamics Cardiac index
Time frame: Between baseline and 3 month follow up
Haemodynamics Cardiac index
Time frame: Between baseline and 6 month follow up
Haemodynamics Perfusion
Time frame: Between baseline and 3 month follow up
Haemodynamics Perfusion
Time frame: Between baseline and 6 month follow up
Haemodynamics Plethvariability
Time frame: Between baseline and 3 month follow up
Haemodynamics Plethvariability
Time frame: Between baseline and 6 month follow up
Oxygen Saturation
Time frame: Between baseline and 3 month follow up
Oxygen Saturation
Time frame: Between baseline and 6 month follow up
ACQ
Time frame: Between baseline and 3 month follow up
ACQ
Time frame: Between baseline and 6 month follow up
AQLQ
Time frame: Between baseline and 3 month follow up
AQLQ
Time frame: Between baseline and 6 month follow up
ARCIM Questionnaire
Time frame: Between baseline and 3 month follow up
ARCIM Questionnaire
Time frame: Between baseline and 6 month follow up
STAI Questionnaire
Time frame: Between baseline and 3 month follow up
STAI Questionnaire
Time frame: Between baseline and 6 month follow up
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 9 May 2018.
- Derived from this study: PubMed 38212823Vagedes K, Kuderer S, Ehmann R, Kohl M, Wildhaber J, Jorres RA, Vagedes J. Effect of Buteyko breathing technique on clinical and functional parameters in adult patients with asthma: a randomized, controlled study. Eur J Med Res. 2024 Jan 11;29(1):42. doi: 10.1186/s40001-023-01634-1.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Buteyko Breathing Technique in people with Asthma, run by ARCIM Institute Academic Research in Complementary and Integrative Medicine at 1 site in Germany.
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 1 inclusion and 1 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 9 May 2018. 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 Germany. 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.
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 in Endtidal CO2 (time frame: Between baseline and 3 month follow up). The study lists 3 primary outcomes in all. 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 NCT03098849, 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 9 May 2018.