Does Addition of Oscillatory Positive Expiratory Pressure (OPEP) Device to a Chest Physiotherapy Program Provide Further Health Benefits in Children With Bronchiectasis?
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 42
- 试验地点
- 2
- 主要终点
- Change from baseline Peak Expiratory Flow (PEF) at 8 weeks
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 8 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of bronchiectasis
排除标准
- •Hospitalization history during past month
- •Diagnosis of any other chronic childhood diseases such as cerebral palsy or neuromuscular diseases which may impede exercise tolerance
结局指标
主要结局
Change from baseline Peak Expiratory Flow (PEF) at 8 weeks
时间窗: 8 weeks
Peak Expiratory Flow (PEF) will be measured using Spiropalm 6MWT device
Change from baseline breathing reserve at 8 weeks
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 8 weeks
Forced Vital Capacity (FVC) will be measured using Spiropalm 6MWT device
Change from baseline six-minute walk distance at 8 weeks
时间窗: 8 weeks
Distance walked in six minutes will be recorded in six-minute walk test.
Change from baseline M. Quadriceps strength at 8 weeks
时间窗: 8 weeks
M. Quadriceps strength will be measured using hand-held dynamometer
次要结局
未报告次要终点
研究者
Melih Zeren
Assist. Prof. Dr.
Izmir Bakircay University