Buteyko Method for Children With Asthma

Study Overview
=================
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 .

Official Title
-----------------
Buteyko Method for Children With Asthma: a Randomized Controlled Trial

Conditions
-----------------
Asthma, Child, Breathing Exercises

Intervention / Treatment
-----------------
* Other: Buteyko
* Other: Asthma education


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 7 Years
Maximum Age: 12 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Buteyko<br>Children in the intervention group will perform 6 sessions (twice a week) of treatment with the Buteyko Method. | Other: Buteyko<br>* Intervention will be held twice a week during 3 weeks.<br>|
| Active Comparator: Asthma education<br>Children assigned to the control group will receive, along with their parents, educational interventions in relation to asthma. | Other: Asthma education<br>* Educational interventions in relation to asthma will be given to children assigned to the control group.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Quality of life (questionnaire) | Quality of life will be assessed by the Pediatric Asthma Quality of Life Questionnaire (PAQLQ). | Baseline and three weeks later | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Baseline and three weeks later | 
| Change in the Six-minute walk test distance |  | Baseline and three weeks later | 
| Number of visits to the emergency room |  | Through study completion, an average of three weeks | 
| Occurrence of absences in school |  | Through study completion, an average of three weeks | 
| Occurrence of exacerbations | Occurrence of asthma exacerbations or allergy episodes | Through study completion, an average of three weeks | 
| Occurrence of Beta2-agonists usage |  | Through study completion, an average of three weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Asthma, Physical Therapy Specialty, Breathing Exercises, Child, Clinical Trail