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Effectiveness of a Buteyko-based Breathing Technique for Asthma Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03098849
Recruitment Status : Completed
First Posted : April 4, 2017
Last Update Posted : May 9, 2018
Sponsor:
Collaborator:
University Hospital Tuebingen
Information provided by (Responsible Party):
ARCIM Institute Academic Research in Complementary and Integrative Medicine

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

Condition or disease Intervention/treatment Phase
Asthma Other: Buteyko Breathing Technique Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 63 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effectiveness of a Buteyko-based Breathing Technique on Psycho-physiological Parameters of Adults With Asthma - a Randomized, Controlled Study
Actual Study Start Date : January 25, 2017
Actual Primary Completion Date : October 26, 2017
Actual Study Completion Date : October 26, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. Change in Endtidal CO2 [ Time Frame: Between baseline and 3 month follow up ]
    Capnometry

  2. Change in Nijmegen-Score [ Time Frame: Between baseline and 3 month follow up ]
    Questionnare assessing hyperventilation

  3. Change in Buteyko CP [ Time Frame: Between baseline and 3 month follow up ]
    Breath hold test


Secondary Outcome Measures :
  1. Spirometry: FEV1 [ Time Frame: Between baseline and 3 month follow up ]
    FEV1

  2. Spirometry: FEV1 [ Time Frame: Between baseline and 6 month follow up ]
    FEV1

  3. Spirometry: FEV1/VCin [ Time Frame: Between baseline and 3 month follow up ]
    FEV1/VCin

  4. Spirometry: FEV1/VCin [ Time Frame: Between baseline and 6 month follow up ]
    FEV1/VCin

  5. Spirometry: PEF [ Time Frame: Between baseline and 3 month follow up ]
    PEF

  6. Spirometry: PEF [ Time Frame: Between baseline and 6 month follow up ]
    PEF

  7. Heart Rate Variability (SDNN) [ Time Frame: Between baseline and 3 month follow up ]
    SDNN

  8. Heart Rate Variability (SDNN) [ Time Frame: Between baseline and 6 month follow up ]
    SDNN

  9. Heart Rate Variability (RMSSD) [ Time Frame: Between baseline and 3 month follow up ]
    RMSSD

  10. Heart Rate Variability (RMSSD) [ Time Frame: Between baseline and 6 month follow up ]
    RMSSD

  11. Heart Rate Variability (LF/HF) [ Time Frame: Between baseline and 3 month follow up ]
    LF/HF

  12. Heart Rate Variability (LF/HF) [ Time Frame: Between baseline and 6 month follow up ]
    LF/HF

  13. Vascular stiffness [ Time Frame: Between baseline and 3 month follow up ]
    Pulse Wave Velocity

  14. Vascular stiffness [ Time Frame: Between baseline and 6 month follow up ]
    Pulse Wave Velocity

  15. Blood Pressure [ Time Frame: Between baseline and 3 month follow up ]
    Systolic and Diastolic

  16. Blood Pressure [ Time Frame: Between baseline and 6 month follow up ]
    Systolic and Diastolic

  17. Haemodynamics Stroke volume [ Time Frame: Between baseline and 3 month follow up ]
    Stroke volume

  18. Haemodynamics Stroke volume [ Time Frame: Between baseline and 6 month follow up ]
    Stroke volume

  19. Haemodynamics Cardiac output [ Time Frame: Between baseline and 3 month follow up ]
    Cardiac output

  20. Haemodynamics Cardiac output [ Time Frame: Between baseline and 6 month follow up ]
    Cardiac output

  21. Haemodynamics Total Vascular Resistance [ Time Frame: Between baseline and 3 month follow up ]
    Total Vascular Resistance

  22. Haemodynamics Total Vascular Resistance [ Time Frame: Between baseline and 6 month follow up ]
    Total Vascular Resistance

  23. Haemodynamics Cardiac index [ Time Frame: Between baseline and 3 month follow up ]
    Cardiac index

  24. Haemodynamics Cardiac index [ Time Frame: Between baseline and 6 month follow up ]
    Cardiac index

  25. Haemodynamics Perfusion [ Time Frame: Between baseline and 3 month follow up ]
    Perfusion index

  26. Haemodynamics Perfusion [ Time Frame: Between baseline and 6 month follow up ]
    Perfusion index

  27. Haemodynamics Plethvariability [ Time Frame: Between baseline and 3 month follow up ]
    Plethvariability index (PVI)

  28. Haemodynamics Plethvariability [ Time Frame: Between baseline and 6 month follow up ]
    Plethvariability index (PVI)

  29. Oxygen Saturation [ Time Frame: Between baseline and 3 month follow up ]
    SpO2

  30. Oxygen Saturation [ Time Frame: Between baseline and 6 month follow up ]
    SpO2

  31. ACQ [ Time Frame: Between baseline and 3 month follow up ]
    Asthma Control Questionnaire, E. Juniper

  32. ACQ [ Time Frame: Between baseline and 6 month follow up ]
    Asthma Control Questionnaire, E. Juniper

  33. AQLQ [ Time Frame: Between baseline and 3 month follow up ]
    Asthma Quality of Life Questionnaire, E. Juniper

  34. AQLQ [ Time Frame: Between baseline and 6 month follow up ]
    Asthma Quality of Life Questionnaire, E. Juniper

  35. ARCIM Questionnaire [ Time Frame: Between baseline and 3 month follow up ]
    Questionnaire focusing on respiratory complaints like mucus, snoring, blocked nose.

  36. ARCIM Questionnaire [ Time Frame: Between baseline and 6 month follow up ]
    Questionnaire focusing on respiratory complaints like mucus, snoring, blocked nose.

  37. STAI Questionnaire [ Time Frame: Between baseline and 3 month follow up ]
    State and Trait Anxiety Inventory

  38. STAI Questionnaire [ Time Frame: Between baseline and 6 month follow up ]
    State and Trait Anxiety Inventory

  39. ASF Questionnaire [ Time Frame: Between baseline and 3 month follow up ]
    "Aachener Selbstwirksamkeitsfragebogen"

  40. ASF Questionnaire [ Time Frame: Between baseline and 6 month follow up ]
    "Aachener Selbstwirksamkeitsfragebogen"

  41. Asthma medication [ Time Frame: Between baseline and 3 month follow up ]
    Kind and dosage of asthma specific medication like steroids or betamimetics

  42. Asthma medication [ Time Frame: Between baseline and 6 month follow up ]
    Kind and dosage of asthma specific medication like steroids or betamimetics



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03098849


Locations
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Germany
ARCIM Institute
Filderstadt, Baden Württemberg, Germany, 70794
Sponsors and Collaborators
ARCIM Institute Academic Research in Complementary and Integrative Medicine
University Hospital Tuebingen
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Responsible Party: ARCIM Institute Academic Research in Complementary and Integrative Medicine
ClinicalTrials.gov Identifier: NCT03098849    
Other Study ID Numbers: RBT_10
First Posted: April 4, 2017    Key Record Dates
Last Update Posted: May 9, 2018
Last Verified: May 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by ARCIM Institute Academic Research in Complementary and Integrative Medicine:
Buteyko-based breathing technique training
Additional relevant MeSH terms:
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Asthma
Respiratory Aspiration
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Respiration Disorders
Pathologic Processes