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| ID | Type | Description | Link |
|---|---|---|---|
| 2023/10 | Other Grant/Funding Number | Istanbul Atlas University |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Asthma Control | Change from baseline Asthma Control Test at 8 weeks. | 8 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Istanbul Atlas University | Istanbul | Turkey (Türkiye) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42230356 | Derived | 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. |
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| ID | Term |
|---|---|
| D001249 | Asthma |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
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| 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. |
|
| Peak Cough Flow |
Change from baseline peak cough flow at 8 weeks. |
| 8 weeks |
| D012130 |
| Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |