Effectiveness of a Buteyko-based Breathing Technique for Asthma Patients

Asthma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03098849
• Other study ID #: RBT_10
• Status: Completed
• Phase: N/A
• Start date: January 25, 2017
• Est. completion date: October 26, 2017

Study information

• Verified date: May 2018
• Source: ARCIM Institute Academic Research in Complementary and Integrative Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 63
• Est. completion date: October 26, 2017
• Est. primary completion date: October 26, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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)

Related Conditions & MeSH terms

• Asthma
• Respiratory Aspiration

Intervention

Other:
• Buteyko Breathing Technique
Patients are trained in various exercises aiming at breath reduction and breath control as introduced by Dr. K. Buteyko

Locations

Country	Name	City	State
Germany	ARCIM Institute	Filderstadt	Baden Württemberg

Sponsors (2)

Lead Sponsor	Collaborator
ARCIM Institute Academic Research in Complementary and Integrative Medicine	University Hospital Tuebingen

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Endtidal CO2	Capnometry	Between baseline and 3 month follow up
Primary	Change in Nijmegen-Score	Questionnare assessing hyperventilation	Between baseline and 3 month follow up
Primary	Change in Buteyko CP	Breath hold test	Between baseline and 3 month follow up
Secondary	Spirometry: FEV1	FEV1	Between baseline and 3 month follow up
Secondary	Spirometry: FEV1	FEV1	Between baseline and 6 month follow up
Secondary	Spirometry: FEV1/VCin	FEV1/VCin	Between baseline and 3 month follow up
Secondary	Spirometry: FEV1/VCin	FEV1/VCin	Between baseline and 6 month follow up
Secondary	Spirometry: PEF	PEF	Between baseline and 3 month follow up
Secondary	Spirometry: PEF	PEF	Between baseline and 6 month follow up
Secondary	Heart Rate Variability (SDNN)	SDNN	Between baseline and 3 month follow up
Secondary	Heart Rate Variability (SDNN)	SDNN	Between baseline and 6 month follow up
Secondary	Heart Rate Variability (RMSSD)	RMSSD	Between baseline and 3 month follow up
Secondary	Heart Rate Variability (RMSSD)	RMSSD	Between baseline and 6 month follow up
Secondary	Heart Rate Variability (LF/HF)	LF/HF	Between baseline and 3 month follow up
Secondary	Heart Rate Variability (LF/HF)	LF/HF	Between baseline and 6 month follow up
Secondary	Vascular stiffness	Pulse Wave Velocity	Between baseline and 3 month follow up
Secondary	Vascular stiffness	Pulse Wave Velocity	Between baseline and 6 month follow up
Secondary	Blood Pressure	Systolic and Diastolic	Between baseline and 3 month follow up
Secondary	Blood Pressure	Systolic and Diastolic	Between baseline and 6 month follow up
Secondary	Haemodynamics Stroke volume	Stroke volume	Between baseline and 3 month follow up
Secondary	Haemodynamics Stroke volume	Stroke volume	Between baseline and 6 month follow up
Secondary	Haemodynamics Cardiac output	Cardiac output	Between baseline and 3 month follow up
Secondary	Haemodynamics Cardiac output	Cardiac output	Between baseline and 6 month follow up
Secondary	Haemodynamics Total Vascular Resistance	Total Vascular Resistance	Between baseline and 3 month follow up
Secondary	Haemodynamics Total Vascular Resistance	Total Vascular Resistance	Between baseline and 6 month follow up
Secondary	Haemodynamics Cardiac index	Cardiac index	Between baseline and 3 month follow up
Secondary	Haemodynamics Cardiac index	Cardiac index	Between baseline and 6 month follow up
Secondary	Haemodynamics Perfusion	Perfusion index	Between baseline and 3 month follow up
Secondary	Haemodynamics Perfusion	Perfusion index	Between baseline and 6 month follow up
Secondary	Haemodynamics Plethvariability	Plethvariability index (PVI)	Between baseline and 3 month follow up
Secondary	Haemodynamics Plethvariability	Plethvariability index (PVI)	Between baseline and 6 month follow up
Secondary	Oxygen Saturation	SpO2	Between baseline and 3 month follow up
Secondary	Oxygen Saturation	SpO2	Between baseline and 6 month follow up
Secondary	ACQ	Asthma Control Questionnaire, E. Juniper	Between baseline and 3 month follow up
Secondary	ACQ	Asthma Control Questionnaire, E. Juniper	Between baseline and 6 month follow up
Secondary	AQLQ	Asthma Quality of Life Questionnaire, E. Juniper	Between baseline and 3 month follow up
Secondary	AQLQ	Asthma Quality of Life Questionnaire, E. Juniper	Between baseline and 6 month follow up
Secondary	ARCIM Questionnaire	Questionnaire focusing on respiratory complaints like mucus, snoring, blocked nose.	Between baseline and 3 month follow up
Secondary	ARCIM Questionnaire	Questionnaire focusing on respiratory complaints like mucus, snoring, blocked nose.	Between baseline and 6 month follow up
Secondary	STAI Questionnaire	State and Trait Anxiety Inventory	Between baseline and 3 month follow up
Secondary	STAI Questionnaire	State and Trait Anxiety Inventory	Between baseline and 6 month follow up
Secondary	ASF Questionnaire	"Aachener Selbstwirksamkeitsfragebogen"	Between baseline and 3 month follow up
Secondary	ASF Questionnaire	"Aachener Selbstwirksamkeitsfragebogen"	Between baseline and 6 month follow up
Secondary	Asthma medication	Kind and dosage of asthma specific medication like steroids or betamimetics	Between baseline and 3 month follow up
Secondary	Asthma medication	Kind and dosage of asthma specific medication like steroids or betamimetics	Between baseline and 6 month follow up