NCT02720380

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at below P25 for not_applicable asthma

Timeline
Completed

Started Jul 2015

Shorter than P25 for not_applicable asthma

Geographic Reach
1 country

1 active site

Status
completed

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

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

March 7, 2016

Completed
18 days until next milestone

First Posted

Study publicly available on registry

March 25, 2016

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2016

Completed
Last Updated

January 24, 2017

Status Verified

January 1, 2017

Enrollment Period

10 months

First QC Date

March 7, 2016

Last Update Submit

January 20, 2017

Conditions

Keywords

AsthmaPhysical Therapy SpecialtyBreathing ExercisesChildClinical Trail

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

EXPERIMENTAL

Children in the intervention group will perform 6 sessions (twice a week) of treatment with the Buteyko Method.

Other: Buteyko

Asthma education

ACTIVE COMPARATOR

Children assigned to the control group will receive, along with their parents, educational interventions in relation to asthma.

Other: Asthma education

Interventions

ButeykoOTHER

Intervention will be held twice a week during 3 weeks.

Buteyko

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

Asthma education

Eligibility Criteria

Age7 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

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

Location

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

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

Locations