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Completed

NCT Number: NCT07169071

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

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.

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Key information

Conditions

Asthma Childhood Asthma Bronchial Diseases Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Lung Diseases Lung Diseases, Obstructive Respiratory Hypersensitivity Respiratory Muscle Training Respiratory Tract Diseases

Age range

8 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Istanbul Atlas University

Istanbul, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Home-based chest physiotherapy program

Other

he program will include breathing exercises, teaching of relaxation positions, cough training, breathing control strategies, and physical activity recommendations.

Expiratory Muscle Training

Other

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.

Primary outcomes

  1. Respiratory Function Test

    Time frame: 8 weeks

    Change from baseline forced vital capacity (FVC) at 8 weeks.

  2. Respiratory Function Test

    Time frame: 8 weeks

    Change from baseline forced forced expiratory volume in 1 (FEV1) second at 8 weeks.

  3. Respiratory Function Test

    Time frame: 8 weeks

    Change from baseline peak expiratory flow (PEF) at 8 weeks.

  4. Respiratory Function Test

    Time frame: 8 weeks

    Change from baseline FEV1/FVC at 8 weeks.

  5. Respiratory Muscle Strength

    Time frame: 8 weeks

    Change from baseline maximum inspiratory pressure (MIP) at 8 weeks.

  6. Respiratory Muscle Strength

    Time frame: 8 weeks

    Change from baseline maximum expiratory pressure (MEP) at 8 weeks.

  7. Peripheral Muscle Strength

    Time frame: 8 weeks

    Change from baseline m. quadriceps strength at 8 weeks.

  8. Functional Capacity

    Time frame: 8 weeks

    Change from baseline distance covered in six minute walk test at 8 weeks.

  9. Peak Cough Flow

    Time frame: 8 weeks

    Change from baseline peak cough flow at 8 weeks.

Secondary outcomes

  1. Asthma Control

    Time frame: 8 weeks

    Change from baseline Asthma Control Test at 8 weeks.

Sponsors and collaborators

Lead sponsor

Atlas University

Other

Registry information

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Sep 11, 2025
Registry last updated
Dec 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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