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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Asthma, Anxiety, Stress

Intervention / Treatment
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* Other: Mindfulness and Buteyko techniques


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Interventional Model 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).
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Mindfulness and Buteyko techniques<br>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). | Other: Mindfulness and Buteyko techniques<br>* Joint implementation of a general relaxation program and a respiratory rehabilitation program in patients with poorly controlled asthma.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| % 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 | 
| Changes in asthma exacerbation | Changes in asthma exacerbation measured by number of hospital admissions and medical treatments received | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| Pulmonary function | Changes in pulmonary function with spirometry (Forced Expiratory Volume in 1 Second and forced vital capacity) | 1 year | 
| Bronchial inflammation | Changes in bronchial inflammation with FENO | 1 year | 
| Therapeutic adherence of patients to inhalers | Changes in therapeutic adherence of patients to inhalers with the Inhaler Adhesion Test | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Asthma, Anxiety, Stress, Mindfulness, Buteyko