A Randomised Controlled Trial of an Air Warming Mask to Increase Exercise Tolerance in Patients With Stable and Moderate or Severe Chronic Obstructive Pulmonary Disease (COPD).
试验速览
- 阶段
- 不适用
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- The primary outcome measure for the study is the difference between forced expiratory volume in one second (FEV1) in litres per second before and after a 6 minute walk.
研究概览
简要总结
The World Health Organisation defines chronic obstructive pulmonary disease (COPD) as 'not one single disease but an umbrella term used to describe chronic lung diseases that cause limitations in lung airflow' covering emphysema and chronic bronchitis; and estimates (2004) that worldwide there are currently 64 million sufferers with 3 to 4 million in the UK.
COPD results from damaged airways in the lungs, causing them to become narrower and making it harder for air to get in and out of the lungs. It is diagnosed by measuring the amount of air that can be expelled in the first second of breathing out (FEV1) in litres per second.
COPD is a progressive disease and the condition can have a serious impact on the quality of life of sufferers. Going out in very cold weather can cause an immediate drop in FEV1, and increased breathlessness.
This is a randomised crossover controlled trial of participants with COPD. It compares the effectiveness of an air-warming face mask which covers the mouth compared with no face covering, in increasing participants exercise capacity and quality of life in cold weather. The mask warms air at the mouth by drawing on air warmed beneath the participants clothing, through a 20cm long hollow plastic tube and a one-way inspiratory valve into the mask. Air is expired through the nose.
24 participants with moderate or severe COPD, will undertake 3 exercise tests on 3 separate days. Two tests will be in an environmentally controlled chamber performed at 5°C with participants wearing either the mask or no face covering. The third test will be performed at ambient temperature outside the chamber.
The order will be determined by random allocation. Participants will undergo the Treadmill 6 Minute Walk Test; various measurements will be taken, all of which will be non-invasive.
详细描述
Purpose and design
Previous studies have demonstrated the detrimental effect of inhaled cold air for COPD sufferers [1].
Recommendations for COPD sufferers suggest covering the mouth or mouth and nose during cold weather to reduce the impact of cold air, but to date there is no information about how effective this actually is. A previous study of an alternative mask only involved 9 participants with moderate levels of COPD [2].
A further study is needed to establish how effective masks are during cold conditions as they could be a simple, inexpensive way of improving quality of life through exercise, further deterioration of the condition can result from sufferers becoming more sedentary.. A better understanding could be useful for clinicians to advise patients on how and why they can protect themselves from the cold.
NICE guidelines published in 2004 and 2010 highlight the importance of pulmonary rehabilitation in improving the quality of life of COPD patients incorporating a programme of physical training, disease education, nutritional, psychological and behavioural intervention. Exercise has many health benefits, including reducing depression and anxiety; clinical depression and anxiety are common problems for participants with COPD. Exercise can be, or perceived to be difficult for COPD sufferers during cold periods due to brochoconstriction (constriction of the airways in the lungs) and many sufferers can be confined indoors during cold weather in the winter months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males or females diagnosed with COPD, GOLD stage 2 to stage 4
- •Stable COPD
- •≥40 years old
- •Ability to walk for 6 minutes without stopping
- •Medical Research Council (MRC) scale of dyspnoea - grade 3 or above (grade 3 means a patient is limited to walking slower than contemporaries on the level because of breathlessness, or has to stop for breath when walking at own pace).
排除标准
- •Significant disease other than COPD
- •Ischaemic heart disease
- •Use of supplemental oxygen therapy
- •Participants who are unable to walk
- •Unstable or life-threatening cardiac arrhythmia
- •History of myocardial infarction
- •Cold, flu like illness, or other chest infection in the last 8 weeks
- •Participants who are currently experiencing an exacerbation of their COPD
- •Participants who have experienced an exacerbation in the previous 8 weeks
- •Participants who have a known reaction to medical plastics
结局指标
主要结局
The primary outcome measure for the study is the difference between forced expiratory volume in one second (FEV1) in litres per second before and after a 6 minute walk.
时间窗: 2 hours
次要结局
未报告次要终点