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Completed

NCT Number: NCT02720380

Buteyko Method for Children With Asthma

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

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Key information

Age range

7 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Universidade Federal do Rio Grande do Norte (UFRN)

Natal, Rio Grande do Norte, 59078970, Brazil

About this study

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 .

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Buteyko

Other

Intervention will be held twice a week during 3 weeks.

Asthma Education

Other

Educational interventions in relation to asthma will be given to children assigned to the control group.

Primary outcomes

  1. Change in Quality of life (questionnaire)

    Time frame: Baseline and three weeks later

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

Secondary outcomes

  1. Change in pulmonary function (spirometry)

    Time frame: Baseline and three weeks later

    Measured parameters (which will be expressed as percent predicted): FVC, FEV1, FEV1/FVC, FEF25-75%, PEF. PEF will be expressed as L/min.

  2. Change in the Six-minute walk test distance

    Time frame: Baseline and three weeks later

  3. Number of visits to the emergency room

    Time frame: Through study completion, an average of three weeks

  4. Occurrence of absences in school

    Time frame: Through study completion, an average of three weeks

  5. Occurrence of exacerbations

    Time frame: Through study completion, an average of three weeks

    Occurrence of asthma exacerbations or allergy episodes

  6. Occurrence of Beta2-agonists usage

    Time frame: Through study completion, an average of three weeks

Sponsors and collaborators

Lead sponsor

Universidade Federal do Rio Grande do Norte

Other

Registry information

Official study title

Buteyko Method for Children With Asthma: a Randomized Controlled Trial

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Mar 25, 2016
Registry last updated
Jan 24, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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