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Buteyko Method for Children With Asthma

Primary Purpose

Asthma, Child, Breathing Exercises

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Buteyko
Asthma education
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 Asthma, Physical Therapy Specialty, Breathing Exercises, Child, Clinical Trail

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, 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

Active Comparator

Arm Label

Buteyko

Asthma education

Arm Description

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

Children assigned to the control group will receive, along with their parents, educational interventions in relation to asthma.

Outcomes

Primary Outcome Measures

Change in Quality of life (questionnaire)
Quality of life will be assessed by the Pediatric Asthma Quality of Life Questionnaire (PAQLQ).

Secondary Outcome Measures

Change in pulmonary function (spirometry)
Measured parameters (which will be expressed as percent predicted): FVC, FEV1, FEV1/FVC, FEF25-75%, PEF. PEF will be expressed as L/min.
Change in the Six-minute walk test distance
Number of visits to the emergency room
Occurrence of absences in school
Occurrence of exacerbations
Occurrence of asthma exacerbations or allergy episodes
Occurrence of Beta2-agonists usage

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
NCT02720380
Brief Title
Buteyko Method for Children With Asthma
Official Title
Buteyko Method for Children With Asthma: a Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
January 2017
Overall Recruitment Status
Completed
Study Start Date
July 2015 (undefined)
Primary Completion Date
May 2016 (Actual)
Study Completion Date
May 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

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
This study has the aim to assess the effectiveness of the Buteyko method as an adjunct therapy in the treatment of children with asthma.
Detailed Description
Children from 7 to 12 years old with asthma diagnose will be included. Children in the intervention group will perform 6 sessions (twice a week) of treatment with the Buteyko Method. Children assigned to the control group will receive, along with their parents, educational interventions in relation to asthma. The investigators will assess quality of life by the PAQLQ (Paediatric Asthma Quality of Life Questionnaire), pulmonary function (spirometry) and the six-minute walk test. Vital signs, pulmonary auscultation and oxygen peripheral saturation will also be assessed during the tests. In addition, information will be collected on the numbers of hospitalizations, occurence of absence in school due to exacerbation of the disease, asthma symptoms and Beta2-agonists usage .

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma, Child, Breathing Exercises
Keywords
Asthma, Physical Therapy Specialty, Breathing Exercises, Child, Clinical Trail

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Buteyko
Arm Type
Experimental
Arm Description
Children in the intervention group will perform 6 sessions (twice a week) of treatment with the Buteyko Method.
Arm Title
Asthma education
Arm Type
Active Comparator
Arm Description
Children assigned to the control group will receive, along with their parents, educational interventions in relation to asthma.
Intervention Type
Other
Intervention Name(s)
Buteyko
Intervention Description
Intervention will be held twice a week during 3 weeks.
Intervention Type
Other
Intervention Name(s)
Asthma education
Intervention Description
Educational interventions in relation to asthma will be given to children assigned to the control group.
Primary Outcome Measure Information:
Title
Change in Quality of life (questionnaire)
Description
Quality of life will be assessed by the Pediatric Asthma Quality of Life Questionnaire (PAQLQ).
Time Frame
Baseline and three weeks later
Secondary Outcome Measure Information:
Title
Change in pulmonary function (spirometry)
Description
Measured parameters (which will be expressed as percent predicted): FVC, FEV1, FEV1/FVC, FEF25-75%, PEF. PEF will be expressed as L/min.
Time Frame
Baseline and three weeks later
Title
Change in the Six-minute walk test distance
Time Frame
Baseline and three weeks later
Title
Number of visits to the emergency room
Time Frame
Through study completion, an average of three weeks
Title
Occurrence of absences in school
Time Frame
Through study completion, an average of three weeks
Title
Occurrence of exacerbations
Description
Occurrence of asthma exacerbations or allergy episodes
Time Frame
Through study completion, an average of three weeks
Title
Occurrence of Beta2-agonists usage
Time Frame
Through study completion, an average of three weeks

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, 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

Plan to Share IPD
No

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Buteyko Method for Children With Asthma

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