NCT05390554

Brief Summary

Asthma is a complex condition that can impair not only the child's physical growth but also his optimal functional capacity and performance. Buteyko Breathing Technique (BBT) is an exercise designed to regulate the breathing process. The Buteyko technique also proposes lifestyle changes beyond breathing, including diet, allergy avoidance, and stress control. This study aims to evaluate the effect of the Buteyko breathing technique on asthma severity control among school-age children. In Egypt, this technique was applied through five studies, four among adult patients and only one among children. At Mansoura University, only one study was conducted among adult patients, and no studies were conducted among children. To fulfill this knowledge gap, it is necessary to study the effect of this technique on asthma severity control among school-age children. This study will use the Childhood Asthma Control, Peak Expiratory Flow Rate, and Control Pause tests to evaluate the children's asthma severity control.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
33

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2019

Shorter than P25 for not_applicable

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 15, 2019

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 24, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 24, 2019

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

March 21, 2022

Completed
2 months until next milestone

First Posted

Study publicly available on registry

May 25, 2022

Completed
Last Updated

May 25, 2022

Status Verified

April 1, 2022

Enrollment Period

3 months

First QC Date

March 21, 2022

Last Update Submit

May 21, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • Childhood Asthma Control Test(C-ACT)

    The tool is a valid test established by GlaxoSmithKline that involves seven questions to evaluate asthma control and the effects of asthma on diurnal activities among school age children. It has seven questions; the first four are answered by the children and the last three by their parents. Each question had four answer options for children, and six answer options for parents. This part completed at the first and final sessions as a pre and posttest. Its scores were categorized as the following: * 20:27 good asthma control * 10:19 moderate asthma control * Less than 10 poorly asthma control

    4 weeks

Secondary Outcomes (2)

  • Peak Expiratory Flow Rate (PEFR)

    4 weeks

  • Control Pause Test (CP)

    4 weeks

Study Arms (1)

Buteyko Breathing Technique

EXPERIMENTAL

single group pre-post test

Behavioral: Buteyko Breathing Technique

Interventions

* The child was instructed to sit and take a relaxed posture in a vertical chair, relax his shoulders and lean his lower back against the back of the chair. * Until conducting CP, the child was told to avoid alternate breathing, the child was asked to take a small breath in (two seconds), a small breath out (three seconds) and clutch the nose with empty lungs but not too clear on the 'out-breath. To prevent air from escaping through the airways, clutching the nose is necessary. * The researcher estimates how many seconds the child can continue safely before the need to breathe in again, * The child was told to hold their breath until the first need to breathe in was felt. Release the nose then and naturally breathe through it smoothly. * The first intake of breath after the CP should be no higher than the breath before taking the measurement; the child should not hold the breath for too long as this could lead the child to take a major breath after measuring the CP.

Also known as: Breathing Exercises
Buteyko Breathing Technique

Eligibility Criteria

Age6 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • The school age child of both sex whose age range from 6: 12 years to insure the ability of the child to perform Buteyko exercise.
  • The child whose condition is mild to moderate as confirmed by the medical practitioner.
  • The child treated from asthma only by medications and no other alternative treatment as revealed by their primary caregiver.
  • The child and their parents not take any previous instruction about Buteyko method.
  • The child and their parents were accepting participation for four weeks during the study.

You may not qualify if:

  • The child with severe asthma, cardiac disease, mental retardation, pneumonia, infectious disease, lung disease, physical disabilities and psychiatric disorders as confirmed by the medical practitioner.
  • The child who receive any other alternative therapy. The sample size was limited because the starting of the COVID 19 pandemic which affect the children attendance to the clinic and refusal from mothers to continue in the study program.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mansoura University

Al Mansurah, 30016, Egypt

Location

Related Publications (6)

  • Chen E, Shalowitz MU, Story RE, Ehrlich KB, Levine CS, Hayen R, Leigh AK, Miller GE. Dimensions of Socioeconomic Status and Childhood Asthma Outcomes: Evidence for Distinct Behavioral and Biological Associations. Psychosom Med. 2016 Nov-Dec;78(9):1043-1052. doi: 10.1097/PSY.0000000000000392.

    PMID: 27749682BACKGROUND
  • Kuti BP, Omole KO. Epidemiology, triggers, and severity of childhood asthma in Ilesa, Nigeria: Implications for management and control. Niger Med J. 2017 Jan-Feb;58(1):13-20. doi: 10.4103/0300-1652.218412.

    PMID: 29238123BACKGROUND
  • Liu AH, Zeiger R, Sorkness C, Mahr T, Ostrom N, Burgess S, Rosenzweig JC, Manjunath R. Development and cross-sectional validation of the Childhood Asthma Control Test. J Allergy Clin Immunol. 2007 Apr;119(4):817-25. doi: 10.1016/j.jaci.2006.12.662. Epub 2007 Mar 13.

    PMID: 17353040BACKGROUND
  • American Academy of Allergy Asthma and Immunology (AAAAI) (2019). New study sheds light on the challenges and barriers of severe asthma management available at: https://www.aaaai.org/About/News/News/asthma.

    BACKGROUND
  • Buteyko Clinic International (2014). Breathing Exercise 1: The Control Pause (Part I). Available at https://buteykoclinic.com/breathing-exercise-1-the-control-pause-part-i/

    BACKGROUND
  • Kopač, M. (2017). Calculation of Predicted Peak Expiratory Flow in Children with a Formula. Open J Asthma, 1(1), 007-008. Available at https://www.peertechz.com/articles/OJA-1-102.php

    BACKGROUND

MeSH Terms

Interventions

Breathing Exercises

Intervention Hierarchy (Ancestors)

Mind-Body TherapiesComplementary TherapiesTherapeuticsExercise Movement TechniquesPhysical Therapy Modalities

Study Officials

  • Fawzia E Abusaad, Professsor

    Mansoura University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 21, 2022

First Posted

May 25, 2022

Study Start

September 15, 2019

Primary Completion

December 24, 2019

Study Completion

December 24, 2019

Last Updated

May 25, 2022

Record last verified: 2022-04

Locations