Clinical trial NCT03098849: Effectiveness of a Buteyko-based Breathing Technique for Asthma Patients
Official title: Effectiveness of a Buteyko-based Breathing Technique on Psycho-physiological Parameters of Adults With Asthma - a Randomized, Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Asthma
Keywords: Buteyko-based breathing technique training
Lead sponsor: ARCIM Institute Academic Research in Complementary and Integrative Medicine
Sponsor class: OTHER
Collaborators: name: University Hospital Tuebingen
First posted: 2017-04-04
Enrollment: 63
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief 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

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Change in Endtidal CO2
timeFrame: Between baseline and 3 month follow up
measure: Change in Nijmegen-Score
timeFrame: Between baseline and 3 month follow up
measure: Change in Buteyko CP
timeFrame: Between baseline and 3 month follow up
Secondary outcomes:
measure: Spirometry: FEV1
timeFrame: Between baseline and 3 month follow up
measure: Spirometry: FEV1
timeFrame: Between baseline and 6 month follow up
measure: Spirometry: FEV1/VCin
timeFrame: Between baseline and 3 month follow up
measure: Spirometry: FEV1/VCin
timeFrame: Between baseline and 6 month follow up
measure: Spirometry: PEF
timeFrame: Between baseline and 3 month follow up
measure: Spirometry: PEF
timeFrame: Between baseline and 6 month follow up
timeFrame: Between baseline and 3 month follow up
timeFrame: Between baseline and 6 month follow up
measure: Heart Rate Variability (SDNN)
timeFrame: Between baseline and 3 month follow up
measure: Heart Rate Variability (SDNN)
timeFrame: Between baseline and 6 month follow up
measure: Heart Rate Variability (RMSSD)
timeFrame: Between baseline and 3 month follow up
measure: Heart Rate Variability (RMSSD)
timeFrame: Between baseline and 6 month follow up
measure: Heart Rate Variability (LF/HF)
timeFrame: Between baseline and 3 month follow up
measure: Heart Rate Variability (LF/HF)
timeFrame: Between baseline and 6 month follow up
measure: Vascular stiffness
timeFrame: Between baseline and 3 month follow up
measure: Vascular stiffness
timeFrame: Between baseline and 6 month follow up
measure: Blood Pressure
timeFrame: Between baseline and 3 month follow up
measure: Blood Pressure
timeFrame: Between baseline and 6 month follow up
measure: Haemodynamics Stroke volume
timeFrame: Between baseline and 3 month follow up
measure: Haemodynamics Stroke volume
timeFrame: Between baseline and 6 month follow up
measure: Haemodynamics Cardiac output
timeFrame: Between baseline and 3 month follow up
measure: Haemodynamics Cardiac output
timeFrame: Between baseline and 6 month follow up
measure: Haemodynamics Total Vascular Resistance
timeFrame: Between baseline and 3 month follow up
measure: Haemodynamics Total Vascular Resistance
timeFrame: Between baseline and 6 month follow up
measure: Haemodynamics Cardiac index
timeFrame: Between baseline and 3 month follow up
measure: Haemodynamics Cardiac index
timeFrame: Between baseline and 6 month follow up
measure: Haemodynamics Perfusion
timeFrame: Between baseline and 3 month follow up
measure: Haemodynamics Perfusion
timeFrame: Between baseline and 6 month follow up
measure: Haemodynamics Plethvariability
timeFrame: Between baseline and 3 month follow up
measure: Haemodynamics Plethvariability
timeFrame: Between baseline and 6 month follow up
measure: Oxygen Saturation
timeFrame: Between baseline and 3 month follow up
measure: Oxygen Saturation
timeFrame: Between baseline and 6 month follow up
measure: ACQ
timeFrame: Between baseline and 3 month follow up
measure: ACQ
timeFrame: Between baseline and 6 month follow up
measure: AQLQ
timeFrame: Between baseline and 3 month follow up
measure: AQLQ
timeFrame: Between baseline and 6 month follow up
measure: ARCIM Questionnaire
timeFrame: Between baseline and 3 month follow up
measure: ARCIM Questionnaire
timeFrame: Between baseline and 6 month follow up
measure: STAI Questionnaire
timeFrame: Between baseline and 3 month follow up
measure: STAI Questionnaire
timeFrame: Between baseline and 6 month follow up
measure: ASF Questionnaire
timeFrame: Between baseline and 3 month follow up
measure: ASF Questionnaire
timeFrame: Between baseline and 6 month follow up
measure: Asthma medication
timeFrame: Between baseline and 3 month follow up
measure: Asthma medication
timeFrame: Between baseline and 6 month follow up
Other outcomes:
Locations:
city: Filderstadt
country: Germany
facility: ARCIM Institute
state: Baden Württemberg
Study officials:
References: