Buteyko Method for Children With Asthma

Asthma Clinical Trial

Official title:

Buteyko Method for Children With Asthma: a Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02720380
• Other study ID #: 562.554
• Status: Completed
• Phase: N/A
• First received: March 7, 2016
• Last updated: January 20, 2017
• Start date: July 2015
• Est. completion date: May 2016

Study information

• Verified date: January 2017
• Source: Universidade Federal do Rio Grande do Norte
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 .

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: May 2016
• Est. primary completion date: May 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 7 Years to 12 Years

Eligibility

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.

Related Conditions & MeSH terms

• Asthma
• Breathing Exercises
• Child
• Respiratory Aspiration

Intervention

Other:
• Buteyko
Intervention will be held twice a week during 3 weeks.
• Asthma education
Educational interventions in relation to asthma will be given to children assigned to the control group.

Locations

Country	Name	City	State
Brazil	Universidade Federal do Rio Grande do Norte (UFRN)	Natal	Rio Grande do Norte

Sponsors (1)

Lead Sponsor	Collaborator
Universidade Federal do Rio Grande do Norte

Country where clinical trial is conducted

Brazil, 

Outcome

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