Evaluation of SIMEOX Technology on Volumes and Flows Generated in Healthy Subjects and Patients With COPD
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 48
- 试验地点
- 2
- 主要终点
- Change in expiratory flow
研究概览
简要总结
This study will investigate the effects on the SIMEOX technology on flow and volume generated in healthy subjects and patients with COPD
详细描述
This is a crossover study assessing the immediate physiological effects of SIMEOX and a PEP device on the exhalation phase in healthy subjects and patients with COPD.
Participants will perform (1) a slow vital capacity, (2) a maximal expiration from total lung capacity to residual volume with SIMEOX, (3) a maximal expiration from total lung capacity to residual volume with a PEP device.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 45 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy subjects: able to understand the instructions, no acute or chronic respiratory upper or lower airway disease, normal lung function.
- •Patients with COPD: able to understand the instructions; FEV1<80% predicted value, naive to the SIMEOX device.
排除标准
- •Healthy subjects: obesity (BMI > 30kg/m²); active or former smoker; severe scoliosis; cardiovascular or neuromuscular disease.
- •Patients with COPD: obesity (BMI > 30kg/m²); severe scoliosis; cardiovascular or neuromuscular disease.
结局指标
主要结局
Change in expiratory flow
时间窗: 5 minutes
Expiratory flow change between the 3 conditions (spontaneous expiration, SIMEOX and PEP).
Change in expiratory volume
时间窗: 5 minutes
Expiratory volume change between the 3 conditions (spontaneous expiration, SIMEOX and PEP).
次要结局
未报告次要终点
研究者
William Poncin, PT, PhD
Principal Investigator
Cliniques universitaires Saint-Luc- Université Catholique de Louvain