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Effectiveness of a Buteyko-based Breathing Technique for Asthma Patients

Primary Purpose

Asthma

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Buteyko Breathing Technique
Sponsored by
ARCIM Institute Academic Research in Complementary and Integrative Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Asthma focused on measuring Buteyko-based breathing technique training

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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)

Sites / Locations

  • ARCIM Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Buteyko Training

Control Group

Arm Description

Breathing exercises according to the Buteyko Breathing Technique

Standard care as usual

Outcomes

Primary Outcome Measures

Change in Endtidal CO2
Capnometry
Change in Nijmegen-Score
Questionnare assessing hyperventilation
Change in Buteyko CP
Breath hold test

Secondary Outcome Measures

Spirometry: FEV1
FEV1
Spirometry: FEV1
FEV1
Spirometry: FEV1/VCin
FEV1/VCin
Spirometry: FEV1/VCin
FEV1/VCin
Spirometry: PEF
PEF
Spirometry: PEF
PEF
Oral exhaled Nitric oxide
Oral exhaled Nitric oxide
Heart Rate Variability (SDNN)
SDNN
Heart Rate Variability (SDNN)
SDNN
Heart Rate Variability (RMSSD)
RMSSD
Heart Rate Variability (RMSSD)
RMSSD
Heart Rate Variability (LF/HF)
LF/HF
Heart Rate Variability (LF/HF)
LF/HF
Vascular stiffness
Pulse Wave Velocity
Vascular stiffness
Pulse Wave Velocity
Blood Pressure
Systolic and Diastolic
Blood Pressure
Systolic and Diastolic
Haemodynamics Stroke volume
Stroke volume
Haemodynamics Stroke volume
Stroke volume
Haemodynamics Cardiac output
Cardiac output
Haemodynamics Cardiac output
Cardiac output
Haemodynamics Total Vascular Resistance
Total Vascular Resistance
Haemodynamics Total Vascular Resistance
Total Vascular Resistance
Haemodynamics Cardiac index
Cardiac index
Haemodynamics Cardiac index
Cardiac index
Haemodynamics Perfusion
Perfusion index
Haemodynamics Perfusion
Perfusion index
Haemodynamics Plethvariability
Plethvariability index (PVI)
Haemodynamics Plethvariability
Plethvariability index (PVI)
Oxygen Saturation
SpO2
Oxygen Saturation
SpO2
ACQ
Asthma Control Questionnaire, E. Juniper
ACQ
Asthma Control Questionnaire, E. Juniper
AQLQ
Asthma Quality of Life Questionnaire, E. Juniper
AQLQ
Asthma Quality of Life Questionnaire, E. Juniper
ARCIM Questionnaire
Questionnaire focusing on respiratory complaints like mucus, snoring, blocked nose.
ARCIM Questionnaire
Questionnaire focusing on respiratory complaints like mucus, snoring, blocked nose.
STAI Questionnaire
State and Trait Anxiety Inventory
STAI Questionnaire
State and Trait Anxiety Inventory
ASF Questionnaire
"Aachener Selbstwirksamkeitsfragebogen"
ASF Questionnaire
"Aachener Selbstwirksamkeitsfragebogen"
Asthma medication
Kind and dosage of asthma specific medication like steroids or betamimetics
Asthma medication
Kind and dosage of asthma specific medication like steroids or betamimetics

Full Information

First Posted
March 10, 2017
Last Updated
May 8, 2018
Sponsor
ARCIM Institute Academic Research in Complementary and Integrative Medicine
Collaborators
University Hospital Tuebingen
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1. Study Identification

Unique Protocol Identification Number
NCT03098849
Brief Title
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

2. Study Status

Record Verification Date
May 2018
Overall Recruitment Status
Completed
Study Start Date
January 25, 2017 (Actual)
Primary Completion Date
October 26, 2017 (Actual)
Study Completion Date
October 26, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
ARCIM Institute Academic Research in Complementary and Integrative Medicine
Collaborators
University Hospital Tuebingen

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma
Keywords
Buteyko-based breathing technique training

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
63 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Buteyko Training
Arm Type
Experimental
Arm Description
Breathing exercises according to the Buteyko Breathing Technique
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
Standard care as usual
Intervention Type
Other
Intervention Name(s)
Buteyko Breathing Technique
Intervention Description
Patients are trained in various exercises aiming at breath reduction and breath control as introduced by Dr. K. Buteyko
Primary Outcome Measure Information:
Title
Change in Endtidal CO2
Description
Capnometry
Time Frame
Between baseline and 3 month follow up
Title
Change in Nijmegen-Score
Description
Questionnare assessing hyperventilation
Time Frame
Between baseline and 3 month follow up
Title
Change in Buteyko CP
Description
Breath hold test
Time Frame
Between baseline and 3 month follow up
Secondary Outcome Measure Information:
Title
Spirometry: FEV1
Description
FEV1
Time Frame
Between baseline and 3 month follow up
Title
Spirometry: FEV1
Description
FEV1
Time Frame
Between baseline and 6 month follow up
Title
Spirometry: FEV1/VCin
Description
FEV1/VCin
Time Frame
Between baseline and 3 month follow up
Title
Spirometry: FEV1/VCin
Description
FEV1/VCin
Time Frame
Between baseline and 6 month follow up
Title
Spirometry: PEF
Description
PEF
Time Frame
Between baseline and 3 month follow up
Title
Spirometry: PEF
Description
PEF
Time Frame
Between baseline and 6 month follow up
Description
Oral exhaled Nitric oxide
Time Frame
Between baseline and 3 month follow up
Description
Oral exhaled Nitric oxide
Time Frame
Between baseline and 6 month follow up
Title
Heart Rate Variability (SDNN)
Description
SDNN
Time Frame
Between baseline and 3 month follow up
Title
Heart Rate Variability (SDNN)
Description
SDNN
Time Frame
Between baseline and 6 month follow up
Title
Heart Rate Variability (RMSSD)
Description
RMSSD
Time Frame
Between baseline and 3 month follow up
Title
Heart Rate Variability (RMSSD)
Description
RMSSD
Time Frame
Between baseline and 6 month follow up
Title
Heart Rate Variability (LF/HF)
Description
LF/HF
Time Frame
Between baseline and 3 month follow up
Title
Heart Rate Variability (LF/HF)
Description
LF/HF
Time Frame
Between baseline and 6 month follow up
Title
Vascular stiffness
Description
Pulse Wave Velocity
Time Frame
Between baseline and 3 month follow up
Title
Vascular stiffness
Description
Pulse Wave Velocity
Time Frame
Between baseline and 6 month follow up
Title
Blood Pressure
Description
Systolic and Diastolic
Time Frame
Between baseline and 3 month follow up
Title
Blood Pressure
Description
Systolic and Diastolic
Time Frame
Between baseline and 6 month follow up
Title
Haemodynamics Stroke volume
Description
Stroke volume
Time Frame
Between baseline and 3 month follow up
Title
Haemodynamics Stroke volume
Description
Stroke volume
Time Frame
Between baseline and 6 month follow up
Title
Haemodynamics Cardiac output
Description
Cardiac output
Time Frame
Between baseline and 3 month follow up
Title
Haemodynamics Cardiac output
Description
Cardiac output
Time Frame
Between baseline and 6 month follow up
Title
Haemodynamics Total Vascular Resistance
Description
Total Vascular Resistance
Time Frame
Between baseline and 3 month follow up
Title
Haemodynamics Total Vascular Resistance
Description
Total Vascular Resistance
Time Frame
Between baseline and 6 month follow up
Title
Haemodynamics Cardiac index
Description
Cardiac index
Time Frame
Between baseline and 3 month follow up
Title
Haemodynamics Cardiac index
Description
Cardiac index
Time Frame
Between baseline and 6 month follow up
Title
Haemodynamics Perfusion
Description
Perfusion index
Time Frame
Between baseline and 3 month follow up
Title
Haemodynamics Perfusion
Description
Perfusion index
Time Frame
Between baseline and 6 month follow up
Title
Haemodynamics Plethvariability
Description
Plethvariability index (PVI)
Time Frame
Between baseline and 3 month follow up
Title
Haemodynamics Plethvariability
Description
Plethvariability index (PVI)
Time Frame
Between baseline and 6 month follow up
Title
Oxygen Saturation
Description
SpO2
Time Frame
Between baseline and 3 month follow up
Title
Oxygen Saturation
Description
SpO2
Time Frame
Between baseline and 6 month follow up
Title
ACQ
Description
Asthma Control Questionnaire, E. Juniper
Time Frame
Between baseline and 3 month follow up
Title
ACQ
Description
Asthma Control Questionnaire, E. Juniper
Time Frame
Between baseline and 6 month follow up
Title
AQLQ
Description
Asthma Quality of Life Questionnaire, E. Juniper
Time Frame
Between baseline and 3 month follow up
Title
AQLQ
Description
Asthma Quality of Life Questionnaire, E. Juniper
Time Frame
Between baseline and 6 month follow up
Title
ARCIM Questionnaire
Description
Questionnaire focusing on respiratory complaints like mucus, snoring, blocked nose.
Time Frame
Between baseline and 3 month follow up
Title
ARCIM Questionnaire
Description
Questionnaire focusing on respiratory complaints like mucus, snoring, blocked nose.
Time Frame
Between baseline and 6 month follow up
Title
STAI Questionnaire
Description
State and Trait Anxiety Inventory
Time Frame
Between baseline and 3 month follow up
Title
STAI Questionnaire
Description
State and Trait Anxiety Inventory
Time Frame
Between baseline and 6 month follow up
Title
ASF Questionnaire
Description
"Aachener Selbstwirksamkeitsfragebogen"
Time Frame
Between baseline and 3 month follow up
Title
ASF Questionnaire
Description
"Aachener Selbstwirksamkeitsfragebogen"
Time Frame
Between baseline and 6 month follow up
Title
Asthma medication
Description
Kind and dosage of asthma specific medication like steroids or betamimetics
Time Frame
Between baseline and 3 month follow up
Title
Asthma medication
Description
Kind and dosage of asthma specific medication like steroids or betamimetics
Time Frame
Between baseline and 6 month follow up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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)
Facility Information:
Facility Name
ARCIM Institute
City
Filderstadt
State/Province
Baden Württemberg
ZIP/Postal Code
70794
Country
Germany

12. IPD Sharing Statement

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Effectiveness of a Buteyko-based Breathing Technique for Asthma Patients

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