Buteyko Method for Asthmatic Children With Mouth Breathing

January 20, 2017 updated by: Karla Morganna Pereira Pinto de Mendonça, Universidade Federal do Rio Grande do Norte

THE EFFECTS OF THE BUTEYKO METHOD IN MOUTH BREATHING ASTHMATIC CHILDREN: A CONTROLLED RANDOMIZED STUDY

To assess the effectiveness of the Buteyko method as an adjunct therapy in the treatment of asthmatic children with mouth breathing.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

35

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 Locations

  • Brazil
    • Rio Grande do Norte
      • Natal, Rio Grande do Norte, Brazil, 59078970
        • Universidade Federal do Rio Grande do Norte (UFRN)

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

7 years to 12 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Children from 7 up to 12 years old with asthma diagnose
  • Regular inhaled corticosteroids with no change in dose in the preceding 4 weeks.
  • Children cannot present: other respiratory disease (such as cystic fibrosis, bronchiectasis, and tuberculosis), retinal detachment, hypertensive crisis, congenital heart defect, pulmonary edema, history of lobectomy or lung segmentectomy, respiratory infections 15 days prior to the evaluations.

Exclusion Criteria:

  • Children that are not able to perform some of the necessary procedures, give up participating in the research and present acute symptoms of respiratory tract during the assessments.

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Buteyko Method
Children will perform 6 sessions (twice a week) of treatment with the Buteyko Method.
Other: Buteyko Method
Intervention will be held twice a week during 3 weeks.
No Intervention: Control
Asthma education.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Sleep disturbance (questionnaire)
Time Frame: Baseline, three weeks later and six months after treatment
Sleep disturbance will be assessed by the sleep disturbance scale for children (SDSC).
Baseline, three weeks later and six months after treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in spirometry (FVC, FEV1, FEV1/FVC, FEF25-75%, PEF)
Time Frame: Baseline, three weeks later and six months after treatment
Baseline, three weeks later and six months after treatment
Change in ventilometry (minute volume and vital capacity)
Time Frame: Baseline, three weeks later and six months after treatment
Minute volume and vital capacity (liters)
Baseline, three weeks later and six months after treatment
Number of hospitalizations
Time Frame: Through study completion, an average of three weeks and six months after treatment
Through study completion, an average of three weeks and six months after treatment
Number of days off-school
Time Frame: During the three weeks of treatment
During the three weeks of treatment

Collaborators and Investigators

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

Sponsor

Universidade Federal do Rio Grande do Norte

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

March 1, 2016

Primary Completion (Actual)

August 1, 2016

Study Completion (Actual)

October 1, 2016

Study Registration Dates

First Submitted

March 7, 2016

First Submitted That Met QC Criteria

March 30, 2016

First Posted (Estimate)

March 31, 2016

Study Record Updates

Last Update Posted (Estimate)

January 24, 2017

Last Update Submitted That Met QC Criteria

January 20, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1.443.588

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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