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

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
63

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • Germany
    • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Buteyko Training
Breathing exercises according to the Buteyko Breathing Technique
Other: 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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
ARCIM Institute Academic Research in Complementary and Integrative Medicine

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
University Hospital Tuebingen

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 25, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 26, 2017

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 26, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 10, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 31, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 4, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 9, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 8, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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