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

March 15, 2023 updated by: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Vicente Plaza Moral, PhD
  • Phone Number: 5971 +34 93 556 56 01
  • Email: vplaza@santpau.cat

Study Locations

  • Spain
      • Barcelona, Spain, 08041
        • Recruiting
        • Hospital de la Santa Creu i Sant Pau. Carrer Mas Casanovas 90.
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2023

Primary Completion (Anticipated)

July 1, 2025

Study Completion (Anticipated)

December 31, 2025

Study Registration Dates

First Submitted

October 10, 2022

First Submitted That Met QC Criteria

October 20, 2022

First Posted (Actual)

October 25, 2022

Study Record Updates

Last Update Posted (Actual)

March 17, 2023

Last Update Submitted That Met QC Criteria

March 15, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IIBSP-MBA-2022-95

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

The plan to share IPD is undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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