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

NCT07169071 | Completed

• 2 other identifiers: AtlasUmkaya052023/10
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Asthma Childhood; Respiratory Muscle Training

Keywords

Asthma; Expiratory Muscle Training

Outcome Measures

Primary Outcomes (9)

• Respiratory Function Test

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

  8 weeks

• Respiratory Function Test

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

  8 weeks

• Respiratory Function Test

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

  8 weeks

• Respiratory Function Test

  Change from baseline FEV1/FVC at 8 weeks.

  8 weeks

• Respiratory Muscle Strength

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

  8 weeks

• Respiratory Muscle Strength

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

  8 weeks

• Peripheral Muscle Strength

  Change from baseline m. quadriceps strength at 8 weeks.

  8 weeks

• Functional Capacity

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

  8 weeks

• Peak Cough Flow

  Change from baseline peak cough flow at 8 weeks.

  8 weeks

Secondary Outcomes (1)

• Asthma Control

  8 weeks

Study Arms (2)

Experimental group

EXPERIMENTAL

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; Other: Expiratory Muscle Training

Control group

SHAM COMPARATOR

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

Interventions

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.

Control group; Experimental group

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.

Experimental group

Eligibility Criteria

• Age: 8 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Atlas University: lead

Study Sites (1)

Istanbul Atlas University

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 5, 2025
• First Posted: September 11, 2025
• Study Start: June 1, 2024
• Primary Completion: July 31, 2025
• Study Completion: October 1, 2025
• Last Updated: December 18, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)