Evaluation of the Impact of a Wearable Noninvasive Positive Pressure Ventilation Device on Physical Activity and Quality of Life in Patients With COPD
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Icadom
- 入组人数
- 40
- 试验地点
- 14
- 主要终点
- Change of daily physical activity measured by actimetry
研究概览
简要总结
The objective is to assess the impact of a wearable Noninvasive Positive Pressure Ventilation, on physical activity and quality of life in patients with severe COPD, complaining of dyspnea.
详细描述
In order to avoid the occurrence of uncomfortable dyspnea, patients with Chronic Obstructive Pulmonary Disease (COPD) are locked in a vicious circle of inactivity and social isolation which profoundly affects their quality of life and prognosis. A new wearable non invasive positive pressure ventilation device has been recently proposed; it can be used by intermittence during or after physical activities for reducing dyspnea or for shortening dyspnea- recovery time. The investigators hypothesize that this system, in reducing the inconvenience caused by dyspnea, would stimulate a more active lifestyle and improve quality of life. Their objective is to assess the impact of this device on physical activity and quality of life in patients with severe COPD, complaining of dyspnea.
In this open study with no control group, participants will use the device at their convenience, according to their needs in daily life and for 4 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Device Feasibility
- 盲法
- None
入排标准
- 年龄范围
- 35 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with stable severe COPD (with FEV1 ≤50% predicted)
- •Patients with mMRC score > ou = 2.
排除标准
- •Exacerbate within a month prior.
- •Using other non invasive ventilation device > 15h per day.
- •Have musculoskeletal or neuromuscular problem affecting balance and walking.
- •Have cognitive problem affecting comprehension of the different évaluations or questionnaires.
- •Have recently participated in physical training or rehabilitation program (≤ 3 months).
- •Medical contra-indication to NIV.
- •Evolutionary pathologies (excluding COPD) may be life-threatening in the short term (1 year) (cancer, neuromuscular disease rapidly changing).
- •Simultaneously enrolled in an other clinical trial.
- •Not affiliated to social security.
- •Person deprived of liberty, major protected by law.
研究组 & 干预措施
Noninvasive ventilation
Participants will use the device at home by intermittence during or after physical activities for reducing dyspnea or for shortening dyspnea-recovery time over a 4-week period.
干预措施: Non-Invasive Ventilation (Device)
结局指标
主要结局
Change of daily physical activity measured by actimetry
时间窗: Continuously over a 8-week period (2 weeks before the use of the device, over the 4-week period usinf the device and 2 weeks after the use of the device
Change of number of steps by day and daily energy expenditure over the 8 week period
次要结局
- Change of Transition Dyspnea Index (TDI)(baseline and post use of the Vitabreath device at 4th weeks)
- Change of Chronic Obstructive Pulmonary Disease Assessment Test (CAT)score(Continuously over a 8-week period (2 weeks before the use of the device, over the 4-week period usinf the device and 2 weeks after the use of the device)
- Subjective appréciation of the device(post use of the Vitabreath device at 4th weeks)
- Change of Modified Medical Research Council Questionnaire (mMRC) score(baseline and post use of the Vitabreath device at 4th weeks)
- Change of Baseline Dyspnea Index (BDI) score(baseline and post use of the Vitabreath device at 4th weeks)
- Change of Visual Simplified Respiratory Questionnaire (VSRQ) score(baseline and post use of the Vitabreath device at 4th weeks)