Asthma (Diagnosis)NCT07880145
Effects of Respiratory Muscle Strength Training in Children With Asthma
A study testing Exercise in people with Asthma (Diagnosis), run by Hasan Kalyoncu University at 1 site in Turkey (Türkiye).
Trial summary
Asthma is a common long-term respiratory condition in children. In addition to affecting breathing, asthma may affect physical activity, exercise capacity, daily functioning, and quality of life. Read more about this study
- Who is it for?
- Ages 12 to 18 years
- Conditions the study is for
- Asthma (Diagnosis)
- What is being tested?
- Exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Oct 2026to Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 12 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Aged between 12 and 18 years.
- Diagnosed with asthma according to the Global Initiative for Asthma (GINA) criteria.
- Clinically stable asthma.
- No increase in asthma medication dosage within the previous 3 months.
Who cannot join
- Asthma exacerbation requiring prescription of corticosteroid medication.
- History of thoracic surgery.
- Previous participation in a rehabilitation program.
- Presence of other chronic diseases, including neuromuscular, rheumatologic, cardiovascular, or renal diseases.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Mardin Training and Research Hospital
Mardin, Mardin, 47001
Berk Can Özdemir, MSc, +90 553 190 06 59, berkcanozdemir@artuklu.edu.tr
About this study
Official title: Evaluation of the Effects of Respiratory Muscle Strength Training in Children With Asthma Within the Framework of the International Classification of Functioning, Disability and Health
Asthma is a common long-term respiratory condition in children. In addition to affecting breathing, asthma may affect physical activity, exercise capacity, daily functioning, and quality of life. Respiratory muscles, particularly the muscles used for breathing in, play an important role in breathing and may also contribute to physical functioning.
The purpose of this randomized controlled study is to investigate whether adding inspiratory muscle training to a respiratory exercise program provides additional benefits for children with asthma. The study will evaluate the effects of the training using the International Classification of Functioning, Disability and Health (ICF) framework, which provides a broad approach to understanding health by considering body functions, activities, participation, and related aspects of daily life.
Read more
Participants will be randomly assigned to one of two groups. Both groups will perform thoracic mobility and thoracic expansion exercises. In addition, one group will receive inspiratory muscle training for 8 weeks. Before and after the 8-week program, participants will undergo assessments of breathing muscle function, lung function, exercise capacity, autonomic function, physical activity, and quality of life.
The study aims to determine whether inspiratory muscle training can provide additional improvements in respiratory and physical functioning in children with asthma and to evaluate these effects from a broader perspective using the ICF framework.
- Conditions
- Asthma (Diagnosis)
- Being tested
- Exercise
- Keywords
- pediatric asthma, exercise, rehabilitation, ICF, inspiratory muscle training
- Medical subject headings
- Asthma, Disease, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseOther
Inspiratory muscle training will be performed for 8 weeks, 3 days per week, under face-to-face supervision of the researcher using a POWERbreathe Classic Light Resistance device (POWERbreathe International Ltd., Birmingham, UK). Training resistance will initially be set at 40% of the participant's maximal inspiratory pressure (MIP). Participants will perform 30 deep respiratory cycles per session, consisting of three sets of 10 repetitions with 15-minute rest intervals between sets. Training will be performed in a seated position with a nose clip. This intervention will be provided in addition to the thoracic expansion exercise program.
ExerciseOther
Thoracic expansion exercises will be performed as a home-based program for 8 weeks, 3 days per week. Participants will perform slow, deep nasal inspiration while focusing on lateral and anterior expansion of the chest wall, followed by a 3-5-second breath hold and slow expiration through the mouth. On each exercise day, participants will complete 120 repetitions in three daily sessions (40 repetitions in the morning, 40 at noon, and 40 in the evening). Each 40-repetition session will consist of two sets of 20 repetitions with 1-2 minutes of rest between sets. Participants will send the researchers a video of one exercise session at the end of each exercise day.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | Participants in this group will receive inspiratory muscle training in addition to thoracic mobility and thoracic expansion exercises for 8 weeks. Receives: Other: Exercise |
| Control Group | Active comparator | Participants will perform thoracic mobility and thoracic expansion exercises for 8 weeks without additional inspiratory muscle training. Receives: Other: Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Inspiratory Muscle Strength
nspiratory muscle strength will be assessed by measuring maximal inspiratory pressure (MIP) using a respiratory pressure measurement device (COSMED Pony FX, COSMED Srl, Rome, Italy) in accordance with ATS/ERS recommendations. MIP will be recorded in cmH2O. Measurements will be performed before and after the 8-week intervention.
Measured: Baseline and after the 8-week intervention
Pulmonary Function
Pulmonary function will be assessed using spirometry. Forced expiratory volume in one second (FEV1), forced vital capacity (FVC), and the FEV1/FVC ratio will be recorded. Peak expiratory flow (PEF) will also be measured using a peak flow meter. Measurements will be performed before and after the 8-week intervention.
Measured: Baseline and immediately after the 8-week intervention
Inspiratory Muscle Endurance
Inspiratory muscle endurance will be assessed using an incremental threshold loading test with a POWERbreathe Classic Light Resistance device. The test will begin at 20% of the participant's maximal inspiratory pressure (MIP), and the load will be increased by 20% of MIP every 2 minutes up to 100% of MIP. The highest successfully completed pressure will be recorded in cmH2O. Measurements will be performed before and after the 8-week intervention.
Measured: Baseline and after the 8-week intervention
Secondary outcomes (5)
Heart Rate Variability
Heart rate variability will be assessed using a Polar H10 heart rate sensor (Polar Electro Oy, Kempele, Finland) with Kubios HRV Scientific software. Low-frequency (LF) and high-frequency (HF) components will be obtained, and the LF/HF ratio will be used to assess sympathovagal balance.
Measured: Baseline and immediately after the 8-week intervention
Functional Exercise Capacity
Functional exercise capacity will be assessed using the 6-Minute Walk Test (6MWT) according to American Thoracic Society recommendations. Participants will walk along a 30-meter course for 6 minutes, and the total distance walked will be recorded in meters. The test will be performed twice with a 15-20-minute rest period between tests, and the greater walking distance will be used for analysis.
Measured: Baseline and immediately after the 8-week intervention
Asthma Control
Asthma control will be assessed using the Turkish version of the Asthma Control Test (ACT). The ACT consists of 5 items assessing asthma symptoms, their effects on daily activities, and rescue medication use during the previous 4 weeks. The total score ranges from 5 to 25, with higher scores indicating better asthma control. Scores of 19 or lower indicate uncontrolled asthma, while scores of 20 or higher indicate controlled asthma.
Measured: Baseline and immediately after the 8-week intervention
Asthma-Related Quality of Life
Asthma-related quality of life will be assessed using the Turkish version of the Pediatric Asthma Quality of Life Questionnaire (PAQLQ). The questionnaire consists of 23 items covering three domains: symptoms, activity limitations, and emotional function. Items are scored on a 7-point scale, with higher scores indicating better quality of life.
Measured: Baseline and immediately after the 8-week intervention
Climate Change Anxiety
Climate change anxiety will be assessed using the Turkish version of the Climate Change Anxiety Scale. The scale consists of 13 items rated on a 5-point Likert scale ranging from 1 (Never) to 5 (Almost Always) and includes cognitive impairment and functional impairment subdomains.
Measured: Baseline and immediately after the 8-week intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2026
- Study startOct 2026 (estimated)
- Primary completionJan 2027 (estimated)
- Study completionJan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Asthma (Diagnosis)Studies 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
- None (open label)
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hasan Kalyoncu University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Berk Can Özdemir, Hasan Kalyoncu University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07880145
- Sponsor's protocol ID
- 2026/036
- Status last verified
- Oct 2026
- First submitted
- 12 Oct 2026
- Last updated
- 19 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is currently no plan to share individual participant data (IPD) because data sharing was not included in the original study protocol or informed consent process.
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effects of Respiratory Muscle Strength Training in Children With Asthma Within the Framework of the International Classification of Functioning, Disability and Health
- ClinicalTrials.gov ID
- NCT07880145
- Acronym / sponsor ID
- 2026/036
- Conditions
- Asthma (Diagnosis)
- Keywords
- pediatric asthma, exercise, rehabilitation, ICF, inspiratory muscle training
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- Hasan Kalyoncu UniversityUniversity, hospital or other
- Study start
- Oct 2026 (estimated)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Jan 2027 (estimated)
- First posted
- 19 Oct 2026 (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.
Asthma is a common long-term respiratory condition in children. In addition to affecting breathing, asthma may affect physical activity, exercise capacity, daily functioning, and quality of life. Respiratory muscles, particularly the muscles used for breathing in, play an important role in breathing and may also contribute to physical functioning.
The purpose of this randomized controlled study is to investigate whether adding inspiratory muscle training to a respiratory exercise program provides additional benefits for children with asthma. The study will evaluate the effects of the training using the International Classification of Functioning, Disability and Health (ICF) framework, which provides a broad approach to understanding health by considering body functions, activities, participation, and related aspects of daily life.
Participants will be randomly assigned to one of two groups. Both groups will perform thoracic mobility and thoracic expansion exercises. In addition, one group will receive inspiratory muscle training for 8 weeks. Before and after the 8-week program, participants will undergo assessments of breathing muscle function, lung function, exercise capacity, autonomic function, physical activity, and quality of life.
The study aims to determine whether inspiratory muscle training can provide additional improvements in respiratory and physical functioning in children with asthma and to evaluate these effects from a broader perspective using the ICF framework.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Other: ExerciseParticipants in this group will receive inspiratory muscle training in addition to thoracic mobility and thoracic expansion exercises for 8 weeks. |
| Control Group | Active comparator | Other: ExerciseParticipants will perform thoracic mobility and thoracic expansion exercises for 8 weeks without additional inspiratory muscle training. |
Who may qualify
- Ages
- 12 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Aged between 12 and 18 years.
- Diagnosed with asthma according to the Global Initiative for Asthma (GINA) criteria.
- Clinically stable asthma.
- No increase in asthma medication dosage within the previous 3 months.
Key exclusion criteria (4 listed)
- Asthma exacerbation requiring prescription of corticosteroid medication.
- History of thoracic surgery.
- Previous participation in a rehabilitation program.
- Presence of other chronic diseases, including neuromuscular, rheumatologic, cardiovascular, or renal diseases.
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 |
|---|---|---|
| ExerciseInspiratory muscle training will be performed for 8 weeks, 3 days per week, under face-to-face supervision of the researcher using a POWERbreathe Classic Light Resistance device (POWERbreathe International Ltd., Birmingham, UK). Training resistance will initially be set at 40% of the participant's maximal inspiratory pressure (MIP). Participants will perform 30 deep respiratory cycles per session, consisting of three sets of 10 repetitions with 15-minute rest intervals between sets. Training will be performed in a seated position with a nose clip. This intervention will be provided in addition to the thoracic expansion exercise program. | Other | Intervention Group |
| ExerciseThoracic expansion exercises will be performed as a home-based program for 8 weeks, 3 days per week. Participants will perform slow, deep nasal inspiration while focusing on lateral and anterior expansion of the chest wall, followed by a 3-5-second breath hold and slow expiration through the mouth. On each exercise day, participants will complete 120 repetitions in three daily sessions (40 repetitions in the morning, 40 at noon, and 40 in the evening). Each 40-repetition session will consist of two sets of 20 repetitions with 1-2 minutes of rest between sets. Participants will send the researchers a video of one exercise session at the end of each exercise day. | Other | Control Group, Intervention Group |
Primary outcome
Inspiratory Muscle Strength
Time frame: Baseline and after the 8-week intervention
nspiratory muscle strength will be assessed by measuring maximal inspiratory pressure (MIP) using a respiratory pressure measurement device (COSMED Pony FX, COSMED Srl, Rome, Italy) in accordance with ATS/ERS recommendations. MIP will be recorded in cmH2O. Measurements will be performed before and after the 8-week intervention.
Pulmonary Function
Time frame: Baseline and immediately after the 8-week intervention
Pulmonary function will be assessed using spirometry. Forced expiratory volume in one second (FEV1), forced vital capacity (FVC), and the FEV1/FVC ratio will be recorded. Peak expiratory flow (PEF) will also be measured using a peak flow meter. Measurements will be performed before and after the 8-week intervention.
Inspiratory Muscle Endurance
Time frame: Baseline and after the 8-week intervention
Inspiratory muscle endurance will be assessed using an incremental threshold loading test with a POWERbreathe Classic Light Resistance device. The test will begin at 20% of the participant's maximal inspiratory pressure (MIP), and the load will be increased by 20% of MIP every 2 minutes up to 100% of MIP. The highest successfully completed pressure will be recorded in cmH2O. Measurements will be performed before and after the 8-week intervention.
5 secondary outcomes
Heart Rate Variability
Time frame: Baseline and immediately after the 8-week intervention
Functional Exercise Capacity
Time frame: Baseline and immediately after the 8-week intervention
Asthma Control
Time frame: Baseline and immediately after the 8-week intervention
Asthma-Related Quality of Life
Time frame: Baseline and immediately after the 8-week intervention
Climate Change Anxiety
Time frame: Baseline and immediately after the 8-week intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2026.
- Individual participant dataSharing planned: No. There is currently no plan to share individual participant data (IPD) because data sharing was not included in the original study protocol or informed consent process.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise in people with Asthma (Diagnosis), run by Hasan Kalyoncu 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 4 inclusion and 4 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: opening soon, as of the sponsor's last update on 19 Oct 2026. 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. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Berk Can Özdemir, MSc (+90 553 190 06 59, berkcanozdemir@artuklu.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Inspiratory Muscle Strength (time frame: Baseline and after the 8-week intervention). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Oct 2026.