Effects of Expiratory Muscle Training in Children With Asthma: A Randomised Controlled Trial

December 17, 2025 updated by: Atlas University
The goal of this randomized clinical trial is to evaluate the effectiveness of expiratory muscle training (EMT) as an adjunct to conventional chest physiotherapy in children with asthma. Respiratory muscle training has been shown to improve muscle strength, functional capacity, and symptom control in adults with asthma, but evidence in pediatric populations is limited, particularly regarding expiratory training. This study aims to determine whether adding EMT to standard physiotherapy enhances pulmonary function, respiratory muscle strength, asthma control, and functional capacity compared to chest physiotherapy alone. The main questions are: (1) Does EMT improve expiratory muscle strength and pulmonary function in children with asthma? (2) Does EMT contribute to better asthma control and overall physical performance? Participants will be randomly assigned to either conventional chest physiotherapy or chest physiotherapy plus EMT. Interventions will be delivered as a home-based, low-cost, feasible program, with training protocols standardized in terms of intensity, frequency, and duration.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Age between 8 and 18 years Clinically diagnosed with asthma Ability to walk, cooperate, and be clinically stable Willingness to participate in the study

Exclusion Criteria:

  • History of hospitalization within the last 4 weeks prior to enrollment Hospitalization during the exercise training program Presence of secondary conditions that may affect respiratory function (e.g., kyphoscoliosis) Currently participating in or having participated in a regular exercise training program within the past year

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental group
Children in the experimental group will receive the same home-based chest physiotherapy program as the control group (8 weeks, 5 days per week, 30 minutes per day). In addition, they will perform expiratory muscle training (EMT) using a threshold device at 30% of their maximum expiratory pressure (MEP). EMT will be applied twice daily for 20 minutes, at least 5 days per week for 8 weeks. Resistance will be increased by 10% each week, adjusted according to tolerance and the presence of any complaints.
Other: Home-based chest physiotherapy program
he program will include breathing exercises, teaching of relaxation positions, cough training, breathing control strategies, and physical activity recommendations.
Other: Expiratory Muscle Training
Participants perform expiratory muscle training (EMT) using a threshold device at 30% of their maximum expiratory pressure (MEP). The program consists of twice daily sessions, each lasting 20 minutes, at least 5 days per week, for 8 weeks. Resistance will be increased by 10% each week, adjusted according to tolerance and the presence of any complaints for experimental group.
Sham Comparator: Control group
Children in the control group will receive a home-based chest physiotherapy program for 8 weeks, 5 days per week, 30 minutes per day. The program will include breathing exercises, teaching of relaxation positions, cough training, breathing control strategies, and physical activity recommendations. In addition, participants will perform sham expiratory muscle training at the lowest fixed load, twice daily for 20 minutes, at least 5 days per week for 8 weeks.
Other: Home-based chest physiotherapy program
he program will include breathing exercises, teaching of relaxation positions, cough training, breathing control strategies, and physical activity recommendations.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Respiratory Function Test
Time Frame: 8 weeks
Change from baseline forced vital capacity (FVC) at 8 weeks.
8 weeks
Respiratory Function Test
Time Frame: 8 weeks
Change from baseline forced forced expiratory volume in 1 (FEV1) second at 8 weeks.
8 weeks
Respiratory Function Test
Time Frame: 8 weeks
Change from baseline peak expiratory flow (PEF) at 8 weeks.
8 weeks
Respiratory Function Test
Time Frame: 8 weeks
Change from baseline FEV1/FVC at 8 weeks.
8 weeks
Respiratory Muscle Strength
Time Frame: 8 weeks
Change from baseline maximum inspiratory pressure (MIP) at 8 weeks.
8 weeks
Respiratory Muscle Strength
Time Frame: 8 weeks
Change from baseline maximum expiratory pressure (MEP) at 8 weeks.
8 weeks
Peripheral Muscle Strength
Time Frame: 8 weeks
Change from baseline m. quadriceps strength at 8 weeks.
8 weeks
Functional Capacity
Time Frame: 8 weeks
Change from baseline distance covered in six minute walk test at 8 weeks.
8 weeks
Peak Cough Flow
Time Frame: 8 weeks
Change from baseline peak cough flow at 8 weeks.
8 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Asthma Control
Time Frame: 8 weeks
Change from baseline Asthma Control Test at 8 weeks.
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Atlas University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2024

Primary Completion (Actual)

July 31, 2025

Study Completion (Actual)

October 1, 2025

Study Registration Dates

First Submitted

September 5, 2025

First Submitted That Met QC Criteria

September 5, 2025

First Posted (Estimated)

September 11, 2025

Study Record Updates

Last Update Posted (Actual)

December 18, 2025

Last Update Submitted That Met QC Criteria

December 17, 2025

Last Verified

September 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AtlasUmkaya05
  • 2023/10 (Other Grant/Funding Number: Istanbul Atlas University)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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