Efficacy of the Combination of Mindfulness and Buteyko Techniques for the Improvement of Poorly Controlled Asthma.

Asthma Clinical Trial

Official title:

Efficacy of the Combination of General Relaxation (Mindfulness) and Respiratory (Buteyko) Techniques for the Improvement of Poorly Controlled Asthma. The MBA Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05593315
• Other study ID #: IIBSP-MBA-2022-95
• Status: Recruiting
• Phase: N/A
• Start date: March 1, 2023
• Est. completion date: December 31, 2025

Study information

• Verified date: March 2023
• Source: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
• Contact: Vicente Plaza Moral, PhD
• Phone: +34 93 556 56 01
• Email: vplaza[@]santpau.cat
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Administration of a combined program for general (Mindfulness) and respiratory (Buteyko technique) relationship in patients with poorly controlled asthma and anxiety/stress to determine if it provides an improvement in current control and future risk of asthma.

Description:

A Mindfulness relaxation program and a Buteyko technique respiratory rehabilitation program will be administered individually and weekly, in 10 sessions (5 face-to-face and 5 telematic sessions afterwards). Patients will be visited 4 times (at inclusion, one month, 6 months and 12 months after the double intervention), where data on asthmatic morbidity, pulmonary function (spirometry), bronchial inflammation (FENO) will be collected and some questionnaires will be administered.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: December 31, 2025
• Est. primary completion date: July 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Diagnosis of poorly controlled asthma
• In treatment with a combination of ICS/LABA at medium doses
• Anxiety and/or functional dyspnea
• Attended in the outpatient consultations of the Asthma Unit of the Pneumology and Allergy Service of the Hospital de la Santa Creu i Sant Pau in Barcelona

Exclusion Criteria:

• Severe asthma exacerbation in the last 30 days
• Severe disabling comorbidity
• Severe psychiatric illness
• Inability to complete questionnaires.

Related Conditions & MeSH terms

• Anxiety
• Asthma
• Stress

Intervention

Other:
• Mindfulness and Buteyko techniques
Joint implementation of a general relaxation program and a respiratory rehabilitation program in patients with poorly controlled asthma.

Locations

Country	Name	City	State
Spain	Hospital de la Santa Creu i Sant Pau. Carrer Mas Casanovas 90.	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Country where clinical trial is conducted

Spain, 

References & Publications (33)

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* Note: There are 33 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	% patients with changed asthma control	Changes in asthma symptoms measured with the asthma control test (minimum 5 as worse value; maximum 25, as the best value)	1 year
Primary	Changes in asthma exacerbation	Changes in asthma exacerbation measured by number of hospital admissions and medical treatments received	1 year
Secondary	Anxiety	Improvement of the anxiety level measured with the test hospital anxiety and depression scale (minimum 0 as the best value, maximum 42 as the worst value)	1 year
Secondary	Functional dyspnea	Changes in functional dyspnea measured with the test Nijmegen (minimum 0 as the worst value, maximum 64 as the worst value)	1 year
Secondary	Pulmonary function	Changes in pulmonary function with spirometry (Forced Expiratory Volume in 1 Second and forced vital capacity)	1 year
Secondary	Bronchial inflammation	Changes in bronchial inflammation with FENO	1 year
Secondary	Therapeutic adherence of patients to inhalers	Changes in therapeutic adherence of patients to inhalers with the "Inhaler Adhesion Test"	1 year