Buteyko Method for Children With Asthma

Buteyko Method for Children With Asthma: a Randomized Controlled Trial

This study has the aim to assess the effectiveness of the Buteyko method as an adjunct therapy in the treatment of children with asthma.

Study Overview

• Status: Completed
• Conditions: Child; Asthma; Breathing Exercises
• Intervention / Treatment: Other: Buteyko; Other: Asthma education

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 .

• Study Type: Interventional
• Enrollment (Actual): 32
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

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, 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

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

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

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

Collaborators and Investigators

• Sponsor: Universidade Federal do Rio Grande do Norte

Study record dates

Study Major Dates

• Study Start: July 1, 2015
• Primary Completion (ACTUAL): May 1, 2016
• Study Completion (ACTUAL): May 1, 2016

Study Registration Dates

• First Submitted: March 7, 2016
• First Submitted That Met QC Criteria: March 21, 2016
• First Posted (ESTIMATE): March 25, 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: Child; Asthma; Physical Therapy Specialty; Breathing Exercises; Clinical Trail
• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Immune System Diseases; Respiration Disorders; Lung Diseases; Hypersensitivity, Immediate; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity; Respiratory Aspiration; Asthma
• Other Study ID Numbers: 562.554

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No