Does Addition of Oscillatory Positive Expiratory Pressure (OPEP) Device to a Chest Physiotherapy Program Provide Further Health Benefits in Children With Bronchiectasis?
- Conditions
- Bronchiectasis
- Interventions
- Other: Chest physiotherapyDevice: Oscillatory Positive Expiratory Pressure (OPEP) device
- Registration Number
- NCT05034900
- Lead Sponsor
- Izmir Bakircay University
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 42
- Diagnosis of bronchiectasis
- Hospitalization history during past month
- Diagnosis of any other chronic childhood diseases such as cerebral palsy or neuromuscular diseases which may impede exercise tolerance
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description OPEP device + Chest Physiotherapy Group Chest physiotherapy 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. Chest Physiotherapy Group Chest physiotherapy 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 Oscillatory Positive Expiratory Pressure (OPEP) device 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.
- Primary Outcome Measures
Name Time Method Change from baseline Peak Expiratory Flow (PEF) at 8 weeks 8 weeks Peak Expiratory Flow (PEF) will be measured using Spiropalm 6MWT device
Change from baseline breathing reserve at 8 weeks 8 weeks Breathing reserve will be measured using Spiropalm 6MWT device during six-minute walk test
Change from baseline Leicester Cough Questionnaire score at 8 weeks 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.
Change from baseline Forced Expiratory Volume in 1 second (FEV1) at 8 weeks 8 weeks Forced Expiratory Volume in 1 second (FEV1) will be measured using Spiropalm 6MWT device
Change from baseline maximum minute ventilation at 8 weeks 8 weeks Maximum minute ventilation will be measured using Spiropalm 6MWT device during six-minute walk test
Change from baseline Forced Vital Capacity (FVC) at 8 weeks 8 weeks Forced Vital Capacity (FVC) will be measured using Spiropalm 6MWT device
Change from baseline six-minute walk distance at 8 weeks 8 weeks Distance walked in six minutes will be recorded in six-minute walk test.
Change from baseline M. Quadriceps strength at 8 weeks 8 weeks M. Quadriceps strength will be measured using hand-held dynamometer
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Ege University Faculty of Medicine, Department of Pediatrics, Division of Pediatric Pulmonology
🇹🇷İzmir, Turkey