Effects on Exercise Capacity, Physical Activity and Quality of Life Using Ambulatory Oxygen in Patients With Chronic Obstructive Pulmonary Disease (COPD) Who Desaturate Only During Exercise
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 144
- 试验地点
- 2
- 主要终点
- Six-minute walk test
研究概览
简要总结
The purpose of this trial is to study the effects on exercise capacity, physical activity, inflammatory markers and quality of life of supplemental ambulatory oxygen, to be used during physical activity, in patients with COPD who are normoxic at rest but hypoxemic during a six-min walk test.
Our hypothesis is that if patients are able to use supplemental oxygen they will be more physically active and thereby improve health related quality of life.
详细描述
Study design The study will employ a parallel design for 6 months including 144 patients (72 patients/group). Patients will be randomized to intervention or control group. The intervention comprises supplemental oxygen to be used during physical activity for 6 months. The control group will receive the same physical activity instructions as the intervention group during the 6 months, but they will not be able to use supplemental oxygen during physical activity.
The study will be a prospective, randomized, single-blind multi-centre intervention study with an intention to treat design (last value carry over). Inclusion will continue until 144 patients have fulfilled the 6 months. Patients will be tested at baseline and after 6 months. There will also be a follow-up after 12 months comprising questionnaires. The study will include centers in Sweden Norway, Finland, and Estonia.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •COPD, Arterial Oxygen Saturation > 8 kilopascal at rest
- •Oxygen Saturation ≤ 88% and a fall in Oxygen Saturation ≥ 4% during a six-minute walk test in ambient air
- •No exacerbation within 4 weeks prior to the study
- •Post-bronchodilator forced expiratory volume at one second < 80% predicted and forced expiratory volume at one second /Vital capacity < 0.7
- •Oxygen Saturation ≥ 92 % during a walk test in self-selected pace with supplemental oxygen. Patients should use supplemental oxygen 10 minutes before the test starts.
- •Non-smoker (smoke free for ≥ 6 months)
- •Interest in being physically active
排除标准
- •Arterial carbon dioxide > 6.5 kilopascal at rest
- •Orthopedic, neurologic or mental impairments that would limit physical activity
- •Neoplastic disease that is anticipated to influence survival
- •Patients exercising with supplemental oxygen
- •Long-term oxygen therapy
- •Patients with arterial auricular fibrillation and/or heart disease that might hinder physical activity as judged by the physician
结局指标
主要结局
Six-minute walk test
时间窗: Change from baseline to 6 months
The patient is supposed to walk as long as possible during six minutes.
次要结局
- Physical activity level(Change from baseline to 6 months)
研究者
Margareta Emtner
PhD, Associate Professor
Uppsala University