The Effect of BiLevel Pressure Support NonInvasive Ventilation on Quality of Life and Exercise Capacity in a COPD Exercise Rehabilitation Program
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 14
- 试验地点
- 1
- 主要终点
- Daily Physical Activity
研究概览
简要总结
This trial hopes to demonstrate the effect of 4 weeks of outpatient exercise rehabilitation on COPD patients. In particular the effect on:
- the amount of daily physical activity
- Quality of life
- The 6-minute walk distance
- Time to exacerbation
and compare it to the effect of 4 weeks of outpatients rehabilitation with Noninvasive Ventilation as an adjunct therapy.
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
- None
入排标准
- 年龄范围
- 18 Years 至 120 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of COPD III+IV
- •Age >18 years
- •Former NIV treatment for at least 6 weeks with a positive end-expiratory pressure of at least 4 cmH2O and a pressure support of 8 cmH2O or higher
排除标准
- •Pulmonary Exacerbation requiring antibiotic treatment or hospitalization during the last 6 weeks
- •non-pulmonary Exercise impairment (amputation, severe heart disease, etc)
- •any disease that precludes exercise training
- •inability to understand the patient information
- •substance abuse
- •oxygen requirement of more than 6l O2/min during exercise
研究组 & 干预措施
Control Arm
This arm will perform the pulmonary rehabilitation as specified with no respiratory assistance.
Intervention Arm
This arm will conduct the pulmonary rehabilitation program with BiLevel Noninvasive Ventilation assistance from a ResMed ventilator.
干预措施: BiLevel Noninvasive Ventilation (Device)
结局指标
主要结局
Daily Physical Activity
时间窗: 3 Months
The primary outcome will be measured by daily activity using accelerometer arm bands. This will be measured at the beginning of the rehabilitation program, at the end and at a 3 month follow up.
Exercise Capacity
时间窗: 6 Weeks
6 Minute Walking Distance will be measured every week during the exercise program.
次要结局
- Change in Physiological Parameters(3 Months)
- Dyspnoea(6 Weeks)
- Quality of Life(3 Months)