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

NCT ID: NCT07169071

Last Updated: 2025-12-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-06-01

Study Completion Date

2025-10-01

Brief Summary

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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.

Detailed Description

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Conditions

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Asthma Childhood Respiratory Muscle Training

Keywords

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Asthma Expiratory Muscle Training

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

Home-based chest physiotherapy program

Intervention Type OTHER

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

Expiratory Muscle Training

Intervention Type 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.

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.

Group Type SHAM_COMPARATOR

Home-based chest physiotherapy program

Intervention Type OTHER

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

Interventions

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Home-based chest physiotherapy program

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

Intervention Type 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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

8 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Atlas University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Istanbul Atlas University

Istanbul, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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2023/10

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

AtlasUmkaya05

Identifier Type: -

Identifier Source: org_study_id