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Clinical Trials/NCT07025616
NCT07025616Not yet recruitingNot Applicable

Effectiveness of Buteyko Breathing Exercise in Children With Uncontrolled Asthma: A Single Blind, Randomized Controlled Trial

Ivan Sofian Wibowo1 site in 1 country74 target enrollmentStarted: June 2025Last updated:
Interventions
Drugs

Trial Snapshot

Phase
Not Applicable
Status
Not yet recruiting
Sponsor
Enrollment
74
Locations
1
Primary Endpoint
Asthma control

Study Overview

Brief Summary

This randomized controlled trial study aimed to measure the effectiveness of the combination of 4-weeks Buteyko breathing exercises and pharmacological therapy compared with pharmacological therapy alone in children with uncontrolled asthma.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Single (Outcomes Assessor)

Eligibility Criteria

Ages
7 Years to 17 Years (Child)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Children aged 7-17 years
  • Uncontrolled or partially controlled asthma (GINA Symptom Control Tool score > 1)
  • Receive bronchodilator therapy, either oral or inhaler from a pediatrician.
  • Children and parents/care givers agree to participate in the study until the end, and parents/care givers sign the informed consent form.
  • Can understand instructions.

Exclusion Criteria

  • Have received Buteyko breathing exercises or other breathing exercises.
  • Have congenital heart disease, pneumonia, or other significant and uncontrolled health disorders.
  • Have severe physical disabilities or mental retardation that could potentially prevent the implementation of Buteyko breathing exercises.
  • Have contraindications for spirometry examination

Arms & Interventions

Buteyko

Experimental

Buteyko breathing exercise plus pharmacological treatment

Intervention: Buteyko (Behavioral)

Buteyko

Experimental

Buteyko breathing exercise plus pharmacological treatment

Intervention: Asthma reliever and controller (Drug)

Control

Active Comparator

Pharmacological treatment

Intervention: Asthma reliever and controller (Drug)

Outcomes

Primary Outcomes

Asthma control

Time Frame: At enrollment and end of fourth-week

Level of asthma control measured by Asthma Control Questionnaire (ACQ) - Indonesian version. Minimum value 0, maximum value 6. Higher score means worse outcome.

Secondary Outcomes

  • Asthma Quality of Life(At enrollment and end of fourth-week)
  • Bronchodilator use(At end of fourth-week)
  • FEV1(At enrollment and end of fourth-week)
  • FVC(At enrollment and end of fourth-week)
  • FEV1/FVC(At enrollment and end of fourth-week)
  • PEFR(At enrollment and end of fourth-week)
  • Control Pause(At enrollment and end of fourth-week)

Investigators

Sponsor
Ivan Sofian Wibowo
Sponsor Class
Other
Responsible Party
Sponsor Investigator
Principal Investigator

Ivan Sofian Wibowo

dr.

Indonesia University

Study Sites (1)

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