NCT02724657

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

87
On Track

Trial Health Score

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

Enrollment
35

participants targeted

Target at below P25 for not_applicable asthma

Timeline
Completed

Started Mar 2016

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

March 1, 2016

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

March 7, 2016

Completed
24 days until next milestone

First Posted

Study publicly available on registry

March 31, 2016

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2016

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2016

Completed
Last Updated

January 24, 2017

Status Verified

January 1, 2017

Enrollment Period

5 months

First QC Date

March 7, 2016

Last Update Submit

January 20, 2017

Conditions

Keywords

ChildBreathing exercises

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

EXPERIMENTAL

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

Other: Buteyko Method

Control

NO INTERVENTION

Asthma education.

Interventions

Intervention will be held twice a week during 3 weeks.

Buteyko Method

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, 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

Location

MeSH Terms

Conditions

AsthmaMouth Breathing

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System DiseasesRespiration DisordersSigns and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and Symptoms

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

Locations