Short-term Effects of SIMEOX on Static Hyperinflation in Patients With Chronic Obstructive Pulmonary Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Change in functional residual capacity (FRC) using body plethysmography
研究概览
简要总结
This study will investigate the effects on the SIMEOX technology on static hyperinflation in patients with chronic obstructive pulmonary disease (COPD).
详细描述
This is a crossover study assessing the short-term effects of SIMEOX and PEP device on static hyperinflation in patients with COPD.
Patients will perform lung function tests (to assess the residual volume and functional residual capacity) before, after and 30 minutes after a 20-min long session of SIMEOX or PEP (depending of randomization).
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
- 否
入选标准
- •Patients with chronic obstructive pulmonary disease,
- •Forced expiratory volume in 1s (FEV1) <80% of predicted value,
- •Stable condition (no pulmonary exacerbation for more than 28 days).
排除标准
- •Routine use of one of the two treatments - SIMEOX and/or PEP,
- •Inability to understand or carry out the instructions,
- •Severe cardiac comorbidity, neuromuscular disease,
- •Severe scoliosis,
- •Patient with a pacemaker.
研究组 & 干预措施
SIMEOX
Participants will have to perform 20 minutes of SIMEOX. Passive exhalation is required using the SIMEOX, starting from tidal volume and going until achieving residual volume.
干预措施: SIMEOX (Device)
PEP
Participants will have to perform 20 minutes of PEP. Active exhalation is required using a PEP device, starting from tidal volume and going until achieving residual volume.
干预措施: PEP (Device)
结局指标
主要结局
Change in functional residual capacity (FRC) using body plethysmography
时间窗: 15 minutes
FRCpleth before, after and 30 minutes after performing SIMEOX and PEP will be compared.
Change in functional residual capacity (FRC) using helium dilution
时间窗: 5 minutes
FRChe before, after and 30 minutes after performing SIMEOX and PEP will be compared.
Change in air trapping
时间窗: 20 minutes
FRCpleth - FRChe before, after and 30 minutes after performing SIMEOX and PEP will be compared.
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