Buteyko Method for Children With Asthma
1 other identifier
interventional
32
1 country
1
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.
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 Jul 2015
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
July 1, 2015
CompletedFirst Submitted
Initial submission to the registry
March 7, 2016
CompletedFirst Posted
Study publicly available on registry
March 25, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2016
CompletedJanuary 24, 2017
January 1, 2017
10 months
March 7, 2016
January 20, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (6)
Change in pulmonary function (spirometry)
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
Through study completion, an average of three weeks
- +1 more secondary outcomes
Study Arms (2)
Buteyko
EXPERIMENTALChildren in the intervention group will perform 6 sessions (twice a week) of treatment with the Buteyko Method.
Asthma education
ACTIVE COMPARATORChildren assigned to the control group will receive, along with their parents, educational interventions in relation to asthma.
Interventions
Educational interventions in relation to asthma will be given to children assigned to the control group.
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, 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 25, 2016
Study Start
July 1, 2015
Primary Completion
May 1, 2016
Study Completion
May 1, 2016
Last Updated
January 24, 2017
Record last verified: 2017-01
Data Sharing
- IPD Sharing
- Will not share