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临床试验/NCT02124343
NCT02124343已完成不适用

A Pilot Study to Examine the Effect of Acute Exercise on Neutrophil Function in Patients With Chronic Obstructive Pulmonary Disease

Hywel Dda Health Board2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2014年3月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
20
试验地点
2
主要终点
Neutrophil response to exercise

研究概览

简要总结

Exercise is a cornerstone of pulmonary rehabilitation in the treatment of Chronic Obstructive Pulmonary Disease (COPD). Although researchers have shown numerous benefits with exercise in COPD patients, most studies have only looked at exercise tolerance and psychological outcomes following training. COPD is characterised by persistent inflammation that can cause progressive decline in lung function and multisystemic complications. This inflammation can be amplified in patients when they suffer acute exacerbations. There is a wellknown relationship between exercise, immune function and risk of infection. Exercise has also been shown to have an antiinflammatory effect when performed regularly. There is a lack of research looking into the inflammatory or immune response to exercise in patients with COPD. The exercise within this study will be individually tailored to patients with COPD based on their validated 6 minute walk test (6MWT) but the protocol will involve interval exercise that has been used previously. This type of exercise is considered most appropriate for research into mechanisms of benefit because it maintains the exercise training effects of other modalities (e.g. continuous low intensity aerobic exercise) while avoiding the occurrence of limitations to exercise in people with lung problems (e.g. dynamic hyperinflation). It also closely mirrors daily activity of someone with COPD.

The investigators want to explore the effects of exercise specifically on immune function in 15 people COPD and compare any changes to 15 Controls. By better understanding the mechanisms of how exercise affects inflammation, the investigators could eventually design better Pulmonary Rehabilitation interventions, especially for those most at risk.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
50 Years 至 80 Years(Adult, Older Adult)
性别
Male
接受健康志愿者

入选标准

  • COPD group - 15 Participants who have been diagnosed with any severity of COPD (according to BTS criteria, i.e. >10 pack-year smoking history and post-bronchodilator spirometry FEV1/FVC ratio <0.70 and FEV<80%) and have completed at least 12 from 18 sessions of a pulmonary rehabilitation programme.
  • Age 50-80 years.
  • Current non-smoker.
  • Control group - 15 Participants who will act as Controls, without COPD or cardiovascular disease
  • Age 50-80 years (ideally of similar gender distribution)
  • Current non-smoker.
  • Spirometry: FEV1/FVC>0.7 and FEV>80% predicted

排除标准

  • Known asthma or allergic rhinitis or other respiratory disease (bronchiectasis, pulmonary fibrosis).
  • A change in any medications within 4 weeks or during the study.
  • Require domiciliary oxygen.
  • Acute exacerbation of COPD within 4 weeks of study entry.
  • Any infection or illness within 4 weeks of study entry.
  • Other active inflammatory conditions e.g. rheumatoid arthritis, cancer, unstable cardiac conditions.
  • Receiving oral steroids or other immunomodulating drugs.
  • Currently undergoing exercise training (including Pulmonary Rehabilitation).
  • Any previous cardiovascular contraindications to exercise (e.g. unstable angina).
  • Inability to complete the 6MWT due to physical or mental impairment.
  • Exhaled CO>10ppm or smoked any cigarettes within 6 months.
  • Inability or unwillingness to sign informed consent.

结局指标

主要结局

Neutrophil response to exercise

时间窗: 4 months

The primary outcome measure for this study is to examine neutrophil responses to acute exercise, including changes in the counts and function of these cells in blood and sputa in order to compare any changes between COPD and age-gender matched controls.

次要结局

  • Different health status and the responses on neutrophil function(4 months)

研究者

发起方
Hywel Dda Health Board
申办方类型
Other
责任方
Principal Investigator
主要研究者

Alex Jenkins

Research Student

Hywel Dda Health Board

研究点 (2)

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