An interventional study of Exercise and Exercise in Asthma (Diagnosis), sponsored by Hasan Kalyoncu University. Not yet recruiting at 1 site in Turkey (Türkiye). Open to participants aged 12 Years to 18 Years. Per ClinicalTrials.gov, last updated 2026-10-19.
Sponsored by Hasan Kalyoncu University · Not applicable, Interventional, and Treatment
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.
4,010 studies on the registry are indexed under Asthma; 514 are open to participants now.
This study's planned enrollment of 32 is below the median of 83 across 2,814 interventional studies indexed under Asthma.
Browse Asthma studies →Hasan Kalyoncu University is the lead sponsor of 165 studies on the registry; 32 are open to participants now.
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Exclusion Criteria:
Participants in this group will receive inspiratory muscle training in addition to thoracic mobility and thoracic expansion exercises for 8 weeks.
Other: Exercise
Participants will perform thoracic mobility and thoracic expansion exercises for 8 weeks without additional inspiratory muscle training.
Other: Exercise
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.
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.
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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline and after the 8-week intervention
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline and immediately after the 8-week intervention
Sociodemographic Data
Age, sex, Height, weight, BMI, Smoking status, economic status, drug treatments, duration of illness
Time frame: At the beginning of the study
Plan to share: 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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From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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