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| Name | Class |
|---|---|
| Ege University | OTHER |
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Oscillatory positive expiratory pressure (OPEP) devices such as Flutter®, Aerobika® or Shaker ® are commonly prescribed in the clinical practice for airway clearance in children with chronic lung diseases including bronchiectasis, cystic fibrosis, and primary ciliary dyskinesia. Health insurance companies may cover these devices in some countries; but this is not a common practice around the world. Therefore, many families have to purchase these devices themselves. Unfortunately, these devices are rather expensive especially in the developing countries and consequently, families become financially burdened. Aim of this study is to investigate whether the addition of OPEP devices to a comprehensive chest physiotherapy program provide additional benefits on pulmonary function and exercise capacity in children with bronchiectasis. Results of this study may help better interpreting the cost-effectiveness of these devices.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Chest Physiotherapy Group | Active Comparator | Patients in this group will perform comprehensive chest physiotherapy program two times a day, 7 days a week for 8 weeks at their homes. |
|
| OPEP device + Chest Physiotherapy Group | Experimental | In addition to the same physiotherapy program applied to the controls, patients in this group will also use OPEP device two times a day, 7 days a week for 8 weeks at their homes. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Chest physiotherapy | Other | Programme will include diaphragmatic breathing exercise, thoracic expansion exercises, postural drainage and coughing techniques. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline Forced Vital Capacity (FVC) at 8 weeks | Forced Vital Capacity (FVC) will be measured using Spiropalm 6MWT device | 8 weeks |
| Change from baseline Forced Expiratory Volume in 1 second (FEV1) at 8 weeks | Forced Expiratory Volume in 1 second (FEV1) will be measured using Spiropalm 6MWT device | 8 weeks |
| Change from baseline Peak Expiratory Flow (PEF) at 8 weeks | Peak Expiratory Flow (PEF) will be measured using Spiropalm 6MWT device | 8 weeks |
| Change from baseline maximum minute ventilation at 8 weeks | Maximum minute ventilation will be measured using Spiropalm 6MWT device during six-minute walk test | 8 weeks |
| Change from baseline breathing reserve at 8 weeks | Breathing reserve will be measured using Spiropalm 6MWT device during six-minute walk test | 8 weeks |
| Change from baseline six-minute walk distance at 8 weeks | Distance walked in six minutes will be recorded in six-minute walk test. | 8 weeks |
| Change from baseline M. Quadriceps strength at 8 weeks | M. Quadriceps strength will be measured using hand-held dynamometer | 8 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ege University Faculty of Medicine, Department of Pediatrics, Division of Pediatric Pulmonology | Izmir | Turkey (Türkiye) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41914274 | Derived | Zeren M, Barlik M, Tosun BNC, Demir E, Gulen F. Does Addition of Oscillatory Positive Expiratory Pressure (OPEP) Device to a Chest Physiotherapy Program Provide Further Benefits in Children With Bronchiectasis?: A Randomized Trial. Pediatr Pulmonol. 2026 Apr;61(4):e71602. doi: 10.1002/ppul.71602. |
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| Oscillatory Positive Expiratory Pressure (OPEP) device | Device | Shaker® device will be used. |
|
| Change from baseline Leicester Cough Questionnaire score at 8 weeks |
Questionnaire consists of 19 items covering physical, psychological and social domains of chronic cough with a 7 point likert response scale (range from 1 to 7). Higher score indicates better quality of life. |
| 8 weeks |
| ID | Term |
|---|---|
| D001987 | Bronchiectasis |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
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