Effectiveness of a Buteyko-based Breathing Technique for Asthma Patients

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

Status

Completed

Conditions

Intervention / Treatment

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

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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