- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03098849
Effectiveness of a Buteyko-based Breathing Technique for Asthma Patients
May 8, 2018 updated by: ARCIM Institute Academic Research in Complementary and Integrative Medicine
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
Study Overview
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 Type
Interventional
Enrollment (Actual)
63
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Baden Württemberg
-
Filderstadt, Baden Württemberg, Germany, 70794
- Arcim Institute
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Written informed consent, regular intake of prescribed asthma medication according to the AWMF scheme level 1, native speaker of german
Exclusion Criteria:
- Participation in another study, comorbidities (heart diseases, cancer still under treatment, psychiatric diseases)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Buteyko Training
Breathing exercises according to the Buteyko Breathing Technique
|
Patients are trained in various exercises aiming at breath reduction and breath control as introduced by Dr. K. Buteyko
|
No Intervention: Control Group
Standard care as usual
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Endtidal CO2
Time Frame: Between baseline and 3 month follow up
|
Capnometry
|
Between baseline and 3 month follow up
|
Change in Nijmegen-Score
Time Frame: Between baseline and 3 month follow up
|
Questionnare assessing hyperventilation
|
Between baseline and 3 month follow up
|
Change in Buteyko CP
Time Frame: Between baseline and 3 month follow up
|
Breath hold test
|
Between baseline and 3 month follow up
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Spirometry: FEV1
Time Frame: Between baseline and 3 month follow up
|
FEV1
|
Between baseline and 3 month follow up
|
Spirometry: FEV1
Time Frame: Between baseline and 6 month follow up
|
FEV1
|
Between baseline and 6 month follow up
|
Spirometry: FEV1/VCin
Time Frame: Between baseline and 3 month follow up
|
FEV1/VCin
|
Between baseline and 3 month follow up
|
Spirometry: FEV1/VCin
Time Frame: Between baseline and 6 month follow up
|
FEV1/VCin
|
Between baseline and 6 month follow up
|
Spirometry: PEF
Time Frame: Between baseline and 3 month follow up
|
PEF
|
Between baseline and 3 month follow up
|
Spirometry: PEF
Time Frame: Between baseline and 6 month follow up
|
PEF
|
Between baseline and 6 month follow up
|
Time Frame: Between baseline and 3 month follow up
|
Oral exhaled Nitric oxide
|
Between baseline and 3 month follow up
|
Time Frame: Between baseline and 6 month follow up
|
Oral exhaled Nitric oxide
|
Between baseline and 6 month follow up
|
Heart Rate Variability (SDNN)
Time Frame: Between baseline and 3 month follow up
|
SDNN
|
Between baseline and 3 month follow up
|
Heart Rate Variability (SDNN)
Time Frame: Between baseline and 6 month follow up
|
SDNN
|
Between baseline and 6 month follow up
|
Heart Rate Variability (RMSSD)
Time Frame: Between baseline and 3 month follow up
|
RMSSD
|
Between baseline and 3 month follow up
|
Heart Rate Variability (RMSSD)
Time Frame: Between baseline and 6 month follow up
|
RMSSD
|
Between baseline and 6 month follow up
|
Heart Rate Variability (LF/HF)
Time Frame: Between baseline and 3 month follow up
|
LF/HF
|
Between baseline and 3 month follow up
|
Heart Rate Variability (LF/HF)
Time Frame: Between baseline and 6 month follow up
|
LF/HF
|
Between baseline and 6 month follow up
|
Vascular stiffness
Time Frame: Between baseline and 3 month follow up
|
Pulse Wave Velocity
|
Between baseline and 3 month follow up
|
Vascular stiffness
Time Frame: Between baseline and 6 month follow up
|
Pulse Wave Velocity
|
Between baseline and 6 month follow up
|
Blood Pressure
Time Frame: Between baseline and 3 month follow up
|
Systolic and Diastolic
|
Between baseline and 3 month follow up
|
Blood Pressure
Time Frame: Between baseline and 6 month follow up
|
Systolic and Diastolic
|
Between baseline and 6 month follow up
|
Haemodynamics Stroke volume
Time Frame: Between baseline and 3 month follow up
|
Stroke volume
|
Between baseline and 3 month follow up
|
Haemodynamics Stroke volume
Time Frame: Between baseline and 6 month follow up
|
Stroke volume
|
Between baseline and 6 month follow up
|
Haemodynamics Cardiac output
Time Frame: Between baseline and 3 month follow up
|
Cardiac output
|
Between baseline and 3 month follow up
|
Haemodynamics Cardiac output
Time Frame: Between baseline and 6 month follow up
|
Cardiac output
|
Between baseline and 6 month follow up
|
Haemodynamics Total Vascular Resistance
Time Frame: Between baseline and 3 month follow up
|
Total Vascular Resistance
|
Between baseline and 3 month follow up
|
Haemodynamics Total Vascular Resistance
Time Frame: Between baseline and 6 month follow up
|
Total Vascular Resistance
|
Between baseline and 6 month follow up
|
Haemodynamics Cardiac index
Time Frame: Between baseline and 3 month follow up
|
Cardiac index
|
Between baseline and 3 month follow up
|
Haemodynamics Cardiac index
Time Frame: Between baseline and 6 month follow up
|
Cardiac index
|
Between baseline and 6 month follow up
|
Haemodynamics Perfusion
Time Frame: Between baseline and 3 month follow up
|
Perfusion index
|
Between baseline and 3 month follow up
|
Haemodynamics Perfusion
Time Frame: Between baseline and 6 month follow up
|
Perfusion index
|
Between baseline and 6 month follow up
|
Haemodynamics Plethvariability
Time Frame: Between baseline and 3 month follow up
|
Plethvariability index (PVI)
|
Between baseline and 3 month follow up
|
Haemodynamics Plethvariability
Time Frame: Between baseline and 6 month follow up
|
Plethvariability index (PVI)
|
Between baseline and 6 month follow up
|
Oxygen Saturation
Time Frame: Between baseline and 3 month follow up
|
SpO2
|
Between baseline and 3 month follow up
|
Oxygen Saturation
Time Frame: Between baseline and 6 month follow up
|
SpO2
|
Between baseline and 6 month follow up
|
ACQ
Time Frame: Between baseline and 3 month follow up
|
Asthma Control Questionnaire, E. Juniper
|
Between baseline and 3 month follow up
|
ACQ
Time Frame: Between baseline and 6 month follow up
|
Asthma Control Questionnaire, E. Juniper
|
Between baseline and 6 month follow up
|
AQLQ
Time Frame: Between baseline and 3 month follow up
|
Asthma Quality of Life Questionnaire, E. Juniper
|
Between baseline and 3 month follow up
|
AQLQ
Time Frame: Between baseline and 6 month follow up
|
Asthma Quality of Life Questionnaire, E. Juniper
|
Between baseline and 6 month follow up
|
ARCIM Questionnaire
Time Frame: Between baseline and 3 month follow up
|
Questionnaire focusing on respiratory complaints like mucus, snoring, blocked nose.
|
Between baseline and 3 month follow up
|
ARCIM Questionnaire
Time Frame: Between baseline and 6 month follow up
|
Questionnaire focusing on respiratory complaints like mucus, snoring, blocked nose.
|
Between baseline and 6 month follow up
|
STAI Questionnaire
Time Frame: Between baseline and 3 month follow up
|
State and Trait Anxiety Inventory
|
Between baseline and 3 month follow up
|
STAI Questionnaire
Time Frame: Between baseline and 6 month follow up
|
State and Trait Anxiety Inventory
|
Between baseline and 6 month follow up
|
ASF Questionnaire
Time Frame: Between baseline and 3 month follow up
|
"Aachener Selbstwirksamkeitsfragebogen"
|
Between baseline and 3 month follow up
|
ASF Questionnaire
Time Frame: Between baseline and 6 month follow up
|
"Aachener Selbstwirksamkeitsfragebogen"
|
Between baseline and 6 month follow up
|
Asthma medication
Time Frame: Between baseline and 3 month follow up
|
Kind and dosage of asthma specific medication like steroids or betamimetics
|
Between baseline and 3 month follow up
|
Asthma medication
Time Frame: Between baseline and 6 month follow up
|
Kind and dosage of asthma specific medication like steroids or betamimetics
|
Between baseline and 6 month follow up
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 25, 2017
Primary Completion (Actual)
October 26, 2017
Study Completion (Actual)
October 26, 2017
Study Registration Dates
First Submitted
March 10, 2017
First Submitted That Met QC Criteria
March 31, 2017
First Posted (Actual)
April 4, 2017
Study Record Updates
Last Update Posted (Actual)
May 9, 2018
Last Update Submitted That Met QC Criteria
May 8, 2018
Last Verified
May 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- RBT_10
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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