Asthma ChildhoodNCT07169071
Effects of Expiratory Muscle Training in Children With Asthma: A Randomised Controlled Trial
A study testing Home-based chest physiotherapy program and Expiratory Muscle Training in people with Asthma Childhood and Respiratory Muscle Training, run by Atlas University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 8 to 18 years
- Conditions the study is for
- Asthma Childhood, Respiratory Muscle Training
- What is being tested?
- Home-based chest physiotherapy program and Expiratory Muscle Training
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jun 2024to 1 Oct 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Age between 8 and 18 years Clinically diagnosed with asthma Ability to walk, cooperate, and be clinically stable Willingness to participate in the study
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
- Being tested
- Home-based chest physiotherapy program, Expiratory Muscle Training
- Keywords
- Asthma, Expiratory Muscle Training
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Home-based chest physiotherapy programOther
he program will include breathing exercises, teaching of relaxation positions, cough training, breathing control strategies, and physical activity recommendations.
Expiratory Muscle TrainingOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Home-based chest physiotherapy program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Respiratory Function Test
Change from baseline forced vital capacity (FVC) at 8 weeks.
Measured: 8 weeks
Respiratory Function Test
Change from baseline forced forced expiratory volume in 1 (FEV1) second at 8 weeks.
Measured: 8 weeks
Respiratory Function Test
Change from baseline peak expiratory flow (PEF) at 8 weeks.
Measured: 8 weeks
Respiratory Function Test
Change from baseline FEV1/FVC at 8 weeks.
Measured: 8 weeks
Respiratory Muscle Strength
Change from baseline maximum inspiratory pressure (MIP) at 8 weeks.
Measured: 8 weeks
Respiratory Muscle Strength
Change from baseline maximum expiratory pressure (MEP) at 8 weeks.
Measured: 8 weeks
Peripheral Muscle Strength
Change from baseline m. quadriceps strength at 8 weeks.
Measured: 8 weeks
Functional Capacity
Change from baseline distance covered in six minute walk test at 8 weeks.
Measured: 8 weeks
Peak Cough Flow
Change from baseline peak cough flow at 8 weeks.
Measured: 8 weeks
Secondary outcomes (1)
Asthma Control
Change from baseline Asthma Control Test at 8 weeks.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2025
- Study start1 Jun 2024
- Primary completion31 Jul 2025
- Study completion1 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Asthma ChildhoodStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Atlas University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07169071
- Sponsor's protocol ID
- AtlasUmkaya05
- Other IDs
- 2023/10
- Status last verified
- Sep 2025
- First submitted
- 5 Sep 2025
- Last updated
- 18 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kaya M, Ucgun H, Gemici Karaaslan B, Kiykim A, Denizoglu Kulli H. Is it time to focus on expiratory muscle training in children with asthma? A randomized controlled trial. Eur J Pediatr. 2026 Jun 3;185(7):460. doi: 10.1007/s00431-026-07114-y.
PubMed 42230356
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Expiratory Muscle Training in Children With Asthma: A Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT07169071
- Acronym / sponsor ID
- AtlasUmkaya05
- Conditions
- Asthma Childhood, Respiratory Muscle Training
- Keywords
- Asthma, Expiratory Muscle Training
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Atlas UniversityUniversity, hospital or other
- Study start
- 1 Jun 2024 (actual)
- Primary completion
- 31 Jul 2025 (actual)
- Study completion
- 1 Oct 2025 (actual)
- First posted
- 11 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Other: Home-based chest physiotherapy program, Other: Expiratory Muscle TrainingChildren 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. |
| Control group | Sham comparator | Other: Home-based chest physiotherapy programChildren 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. |
Who may qualify
- Ages
- 8 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Age between 8 and 18 years Clinically diagnosed with asthma Ability to walk, cooperate, and be clinically stable Willingness to participate in the study
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Home-based chest physiotherapy programhe program will include breathing exercises, teaching of relaxation positions, cough training, breathing control strategies, and physical activity recommendations. | Other | Control group, Experimental group |
| Expiratory Muscle TrainingParticipants 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. | Other | Experimental group |
Primary outcome
Respiratory Function Test
Time frame: 8 weeks
Change from baseline forced vital capacity (FVC) at 8 weeks.
Respiratory Function Test
Time frame: 8 weeks
Change from baseline forced forced expiratory volume in 1 (FEV1) second at 8 weeks.
Respiratory Function Test
Time frame: 8 weeks
Change from baseline peak expiratory flow (PEF) at 8 weeks.
Respiratory Function Test
Time frame: 8 weeks
Change from baseline FEV1/FVC at 8 weeks.
Respiratory Muscle Strength
Time frame: 8 weeks
Change from baseline maximum inspiratory pressure (MIP) at 8 weeks.
Respiratory Muscle Strength
Time frame: 8 weeks
Change from baseline maximum expiratory pressure (MEP) at 8 weeks.
Peripheral Muscle Strength
Time frame: 8 weeks
Change from baseline m. quadriceps strength at 8 weeks.
Functional Capacity
Time frame: 8 weeks
Change from baseline distance covered in six minute walk test at 8 weeks.
Peak Cough Flow
Time frame: 8 weeks
Change from baseline peak cough flow at 8 weeks.
1 secondary outcome
Asthma Control
Time frame: 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2025.
- Derived from this study: PubMed 42230356Kaya M, Ucgun H, Gemici Karaaslan B, Kiykim A, Denizoglu Kulli H. Is it time to focus on expiratory muscle training in children with asthma? A randomized controlled trial. Eur J Pediatr. 2026 Jun 3;185(7):460. doi: 10.1007/s00431-026-07114-y.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Home-based chest physiotherapy program and Expiratory Muscle Training in people with Asthma Childhood and Respiratory Muscle Training, run by Atlas University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Respiratory Function Test (time frame: 8 weeks). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07169071, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Dec 2025.