The Additional Effect of Intrapulmonary Percussive Ventilation (IPV) on Respiration in People With Multiple Sclerosis (MS).
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 5
- 试验地点
- 2
- 主要终点
- Change in breathing force
研究概览
简要总结
This study aims to investigate whether intrapulmonary percussive ventilation (IPV) in combination with active breathing exercises using the flow-based incentive spirometer (Inspirix) has a positive effect on the respiratory values in people with multiple sclerosis (MS).
详细描述
The primary research question includes "what is the additional effect of intensive IPV treatment in combination with active breathing exercises on respiratory power (Peak Expiratory Flow, PEF) in people with MS?".
In a single-center randomized clinical trial, 96 people with MS-related respiratory problems will be allocated to either the intervention group (IPV + active breathing training) or the control group (active breathing training only). Interventions will be provided by trained speech- and language therapists, in combination with a multidisciplinary rehabilitation programme of 3 weeks. Pre- en posttraining assessment includes measures of respiration, speech and fatigue.
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
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •diagnosis MS
- •inpatient in the National Multiple Sclerosis Center Melsbroek for at least 3 weeks in the period Jan-Dec 2020
- •adequate lip closure
- •adequate cognitive functioning (MMSE>26/30 & clinical observation)
- •Peak Expiratory Flow (PEF) with a cut off score of 80% or lower
排除标准
- •IPV or other breathing treatment of more than 1x/week within 3 months prior to study participation
- •MS relapse within 3 months prior to study participation
- •asthma or Chronic Obstructive Pulmonary Disease (COPD)
- •infection of lower respiratory tract within 6 weeks prior to study participation
- •infection of upper respiratory tract within 2 weeks prior to study participation
结局指标
主要结局
Change in breathing force
时间窗: pre- post (3 weeks) (some participants also at 4 weeks)
Change in Peak Expiratory Flow (PEF)- Maximum flow achieved during a maximum forced exhalation.
次要结局
- Change in Visual Analogue Scale (VAS) for fatigue(pre- post (3 weeks) (some participants also at 4 weeks))
- Change in Vital Capacity (VC)(pre- post (3 weeks) (some participants also at 4 weeks))
- Change in Maximum Phonation time (MFT)(pre- post (3 weeks) (some participants also at 4 weeks))
- Change in Voice Handicap Index (VHI-10)(pre- post (3 weeks) (some participants also at 4 weeks))
- Change in Maximum Inspiratory Pressure (MIP)(pre- post (3 weeks) (some participants also at 4 weeks))
- Change in Maximum Expiratory Pressure (MEP)(pre- post (3 weeks) (some participants also at 4 weeks))
- Change in Pulmonary Dysfunction Index (PDI)(pre- post (3 weeks) (some participants also at 4 weeks))