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Completed

NCT Number: NCT03098849

Effectiveness of a Buteyko-based Breathing Technique for Asthma Patients

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

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Key information

Conditions

Asthma Bronchial Diseases Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Lung Diseases Lung Diseases, Obstructive Respiratory Hypersensitivity Respiratory Tract Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

ARCIM Institute

Filderstadt, Baden-Wurttemberg, 70794, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Buteyko Breathing Technique

Other

Patients are trained in various exercises aiming at breath reduction and breath control as introduced by Dr. K. Buteyko

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

ARCIM Institute Academic Research in Complementary and Integrative Medicine

Other

Collaborators

  • University Hospital Tuebingen

Registry information

Official study title

Effectiveness of a Buteyko-based Breathing Technique on Psycho-physiological Parameters of Adults With Asthma - a Randomized, Controlled Study

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Apr 4, 2017
Registry last updated
May 9, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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