Buteyko Method for Asthmatic Children With Mouth Breathing
THE EFFECTS OF THE BUTEYKO METHOD IN MOUTH BREATHING ASTHMATIC CHILDREN: A CONTROLLED RANDOMIZED STUDY
1 other identifier
interventional
35
1 country
1
Brief Summary
To assess the effectiveness of the Buteyko method as an adjunct therapy in the treatment of asthmatic children with mouth breathing.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable asthma
Started Mar 2016
Shorter than P25 for not_applicable asthma
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2016
CompletedFirst Submitted
Initial submission to the registry
March 7, 2016
CompletedFirst Posted
Study publicly available on registry
March 31, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2016
CompletedJanuary 24, 2017
January 1, 2017
5 months
March 7, 2016
January 20, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in Sleep disturbance (questionnaire)
Sleep disturbance will be assessed by the sleep disturbance scale for children (SDSC).
Baseline, three weeks later and six months after treatment
Secondary Outcomes (4)
Change in spirometry (FVC, FEV1, FEV1/FVC, FEF25-75%, PEF)
Baseline, three weeks later and six months after treatment
Change in ventilometry (minute volume and vital capacity)
Baseline, three weeks later and six months after treatment
Number of hospitalizations
Through study completion, an average of three weeks and six months after treatment
Number of days off-school
During the three weeks of treatment
Study Arms (2)
Buteyko Method
EXPERIMENTALChildren will perform 6 sessions (twice a week) of treatment with the Buteyko Method.
Control
NO INTERVENTIONAsthma education.
Interventions
Eligibility Criteria
You may qualify if:
- 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, and tuberculosis), retinal detachment, hypertensive crisis, congenital heart defect, pulmonary edema, history of lobectomy or lung segmentectomy, respiratory infections 15 days prior to the evaluations.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Universidade Federal do Rio Grande do Norte (UFRN)
Natal, Rio Grande do Norte, 59078970, Brazil
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal investigator
Study Record Dates
First Submitted
March 7, 2016
First Posted
March 31, 2016
Study Start
March 1, 2016
Primary Completion
August 1, 2016
Study Completion
October 1, 2016
Last Updated
January 24, 2017
Record last verified: 2017-01