High Flow Nasal Cannula Versus The Venturi Mask During Exercise Training in Chronic Obstructive Pulmonary Disease Patients, a Randomized, Simple Blind, Controlled Trial.
试验速览
- 阶段
- 不适用
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Change in Exercise Capacity - Maximum Walking Time Reached
研究概览
简要总结
The aim of this study is to compare exercise capacity in Chronic Obstructive Pulmonary Disease (COPD) patients before and after an 8 week pulmonary rehabilitation program.
Patients will be randomised in two groups, one arm will received oxygen through High Flow Nasal Cannula (HFNC) and the other group by The Venturi Mask (VM)
详细描述
Design: randomized, single blind, controlled trial.
The main goal of this study is to compare the exercise tolerance in COPD patients after an 8 week pulmonary rehabilitation program using High Flow Nasal Cannula or The Venturi Mask. The exercise tolerance will be measured in seconds in a Constant Load Treadmill Test (CTLT).
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 (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Long term oxygen therapy (LTOT) or oxygen needs during exercise.
- •Clinically stable defined as four weeks without exacerbation
排除标准
- •Refusal to participate
- •Any neuromuscular, cardiovascular or any other condition that limits test performance.
- •Contraindication for exercise
研究组 & 干预措施
High Flow Nasal Cannula
During a 8 week Pulmonary Rehabilitation Program patients will receive oxygen through High Flow Nasal Cannula (HFNC) while they are training aerobic capacity on the treadmill.
干预措施: High Flow Nasal Cannula (Device)
The Venturi Mask
During a 8 week Pulmonary Rehabilitation Program patients will receive oxygen through The Venturi Mask (VM) while they are training aerobic capacity on the treadmill.
干预措施: The Venturi Mask (Device)
结局指标
主要结局
Change in Exercise Capacity - Maximum Walking Time Reached
时间窗: 8 weeks
The exercise capacity test measures the maximum time (in minutes) reached during a Constant Load Treadmill Test (CLTT). The treadmill speed will be constant and set up at 90% of the maximum speed reached in the previous Incremental Load Treadmill Test (ILTT). The patient will walk at the same velocity until he exhausts his capacity thus ending the test. This CLTT will be performed three times, always after an Incremental Load Treadmill Test (ILTT)
次要结局
- Six Minutes Walking Test(8 weeks)
- Exercise capacity - Maximum Walking Speed Reached(8 weeks)
- Quality of Life - The St George's Respiratory Questionnaire(8 weeks)
- Quality of Life -Chronic Obstructive Pulmonary Disease Assessment Test(8 weeks)
- Dyspnea(8 weeks)
- Comfort(8 weeks)