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: Asthma
• Intervention / Treatment: Other: Buteyko Breathing Technique

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

Study Locations

• Germany
  • Baden Württemberg
    • Filderstadt, Baden Württemberg, Germany, 70794
      • Arcim Institute

Participation Criteria

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

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Endtidal CO2	Capnometry	Between baseline and 3 month follow up
Change in Nijmegen-Score	Questionnare assessing hyperventilation	Between baseline and 3 month follow up
Change in Buteyko CP	Breath hold test	Between baseline and 3 month follow up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Spirometry: FEV1	FEV1	Between baseline and 3 month follow up
Spirometry: FEV1	FEV1	Between baseline and 6 month follow up
Spirometry: FEV1/VCin	FEV1/VCin	Between baseline and 3 month follow up
Spirometry: FEV1/VCin	FEV1/VCin	Between baseline and 6 month follow up
Spirometry: PEF	PEF	Between baseline and 3 month follow up
Spirometry: PEF	PEF	Between baseline and 6 month follow up
	Oral exhaled Nitric oxide	Between baseline and 3 month follow up
	Oral exhaled Nitric oxide	Between baseline and 6 month follow up
Heart Rate Variability (SDNN)	SDNN	Between baseline and 3 month follow up
Heart Rate Variability (SDNN)	SDNN	Between baseline and 6 month follow up
Heart Rate Variability (RMSSD)	RMSSD	Between baseline and 3 month follow up
Heart Rate Variability (RMSSD)	RMSSD	Between baseline and 6 month follow up
Heart Rate Variability (LF/HF)	LF/HF	Between baseline and 3 month follow up
Heart Rate Variability (LF/HF)	LF/HF	Between baseline and 6 month follow up
Vascular stiffness	Pulse Wave Velocity	Between baseline and 3 month follow up
Vascular stiffness	Pulse Wave Velocity	Between baseline and 6 month follow up
Blood Pressure	Systolic and Diastolic	Between baseline and 3 month follow up
Blood Pressure	Systolic and Diastolic	Between baseline and 6 month follow up
Haemodynamics Stroke volume	Stroke volume	Between baseline and 3 month follow up
Haemodynamics Stroke volume	Stroke volume	Between baseline and 6 month follow up
Haemodynamics Cardiac output	Cardiac output	Between baseline and 3 month follow up
Haemodynamics Cardiac output	Cardiac output	Between baseline and 6 month follow up
Haemodynamics Total Vascular Resistance	Total Vascular Resistance	Between baseline and 3 month follow up
Haemodynamics Total Vascular Resistance	Total Vascular Resistance	Between baseline and 6 month follow up
Haemodynamics Cardiac index	Cardiac index	Between baseline and 3 month follow up
Haemodynamics Cardiac index	Cardiac index	Between baseline and 6 month follow up
Haemodynamics Perfusion	Perfusion index	Between baseline and 3 month follow up
Haemodynamics Perfusion	Perfusion index	Between baseline and 6 month follow up
Haemodynamics Plethvariability	Plethvariability index (PVI)	Between baseline and 3 month follow up
Haemodynamics Plethvariability	Plethvariability index (PVI)	Between baseline and 6 month follow up
Oxygen Saturation	SpO2	Between baseline and 3 month follow up
Oxygen Saturation	SpO2	Between baseline and 6 month follow up
ACQ	Asthma Control Questionnaire, E. Juniper	Between baseline and 3 month follow up
ACQ	Asthma Control Questionnaire, E. Juniper	Between baseline and 6 month follow up
AQLQ	Asthma Quality of Life Questionnaire, E. Juniper	Between baseline and 3 month follow up
AQLQ	Asthma Quality of Life Questionnaire, E. Juniper	Between baseline and 6 month follow up
ARCIM Questionnaire	Questionnaire focusing on respiratory complaints like mucus, snoring, blocked nose.	Between baseline and 3 month follow up
ARCIM Questionnaire	Questionnaire focusing on respiratory complaints like mucus, snoring, blocked nose.	Between baseline and 6 month follow up
STAI Questionnaire	State and Trait Anxiety Inventory	Between baseline and 3 month follow up
STAI Questionnaire	State and Trait Anxiety Inventory	Between baseline and 6 month follow up
ASF Questionnaire	"Aachener Selbstwirksamkeitsfragebogen"	Between baseline and 3 month follow up
ASF Questionnaire	"Aachener Selbstwirksamkeitsfragebogen"	Between baseline and 6 month follow up
Asthma medication	Kind and dosage of asthma specific medication like steroids or betamimetics	Between baseline and 3 month follow up
Asthma medication	Kind and dosage of asthma specific medication like steroids or betamimetics	Between baseline and 6 month follow up

Collaborators and Investigators

• Sponsor: ARCIM Institute Academic Research in Complementary and Integrative Medicine
• Collaborators: University Hospital Tuebingen

Study record dates

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

• Keywords: Buteyko-based breathing technique training
• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Immune System Diseases; Respiration Disorders; Lung Diseases; Hypersensitivity, Immediate; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity; Respiratory Aspiration; Asthma
• Other Study ID 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