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Buteyko Method for Asthmatic Children With Mouth Breathing

Primary Purpose

Asthma, Mouth Breathing

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Buteyko Method
Sponsored by
Universidade Federal do Rio Grande do Norte
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Asthma focused on measuring Child, Breathing exercises

Eligibility Criteria

7 Years - 12 Years (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Universidade Federal do Rio Grande do Norte (UFRN)

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Buteyko Method

Control

Arm Description

Children will perform 6 sessions (twice a week) of treatment with the Buteyko Method.

Asthma education.

Outcomes

Primary Outcome Measures

Change in Sleep disturbance (questionnaire)
Sleep disturbance will be assessed by the sleep disturbance scale for children (SDSC).

Secondary Outcome Measures

Change in spirometry (FVC, FEV1, FEV1/FVC, FEF25-75%, PEF)
Change in ventilometry (minute volume and vital capacity)
Minute volume and vital capacity (liters)
Number of hospitalizations
Number of days off-school

Full Information

First Posted
March 7, 2016
Last Updated
January 20, 2017
Sponsor
Universidade Federal do Rio Grande do Norte
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1. Study Identification

Unique Protocol Identification Number
NCT02724657
Brief Title
Buteyko Method for Asthmatic Children With Mouth Breathing
Official Title
THE EFFECTS OF THE BUTEYKO METHOD IN MOUTH BREATHING ASTHMATIC CHILDREN: A CONTROLLED RANDOMIZED STUDY
Study Type
Interventional

2. Study Status

Record Verification Date
January 2017
Overall Recruitment Status
Completed
Study Start Date
March 2016 (undefined)
Primary Completion Date
August 2016 (Actual)
Study Completion Date
October 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidade Federal do Rio Grande do Norte

4. Oversight

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma, Mouth Breathing
Keywords
Child, Breathing exercises

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
35 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Buteyko Method
Arm Type
Experimental
Arm Description
Children will perform 6 sessions (twice a week) of treatment with the Buteyko Method.
Arm Title
Control
Arm Type
No Intervention
Arm Description
Asthma education.
Intervention Type
Other
Intervention Name(s)
Buteyko Method
Intervention Description
Intervention will be held twice a week during 3 weeks.
Primary Outcome Measure Information:
Title
Change in Sleep disturbance (questionnaire)
Description
Sleep disturbance will be assessed by the sleep disturbance scale for children (SDSC).
Time Frame
Baseline, three weeks later and six months after treatment
Secondary Outcome Measure Information:
Title
Change in spirometry (FVC, FEV1, FEV1/FVC, FEF25-75%, PEF)
Time Frame
Baseline, three weeks later and six months after treatment
Title
Change in ventilometry (minute volume and vital capacity)
Description
Minute volume and vital capacity (liters)
Time Frame
Baseline, three weeks later and six months after treatment
Title
Number of hospitalizations
Time Frame
Through study completion, an average of three weeks and six months after treatment
Title
Number of days off-school
Time Frame
During the three weeks of treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
7 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Universidade Federal do Rio Grande do Norte (UFRN)
City
Natal
State/Province
Rio Grande do Norte
ZIP/Postal Code
59078970
Country
Brazil

12. IPD Sharing Statement

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Buteyko Method for Asthmatic Children With Mouth Breathing

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