Changes in Inflammatory Markers During Pulmonary Rehabilitation Based on Exacerbation States in COPD (CIMPRES-COPD)
2018年10月18日 更新者：Alex Jenkins、University of Lincoln
This study will examine the inflammatory response to exercise encompassed as part of a standard pulmonary rehabilitation programme in patients with chronic obstructive pulmonary disease (COPD).
Patients will be split into two groups, frequent exacerbators or infrequent exacerbators, dependent upon exacerbation history to compare responses to pulmonary rehabilitation amongst phenotypes.
研究概览
详细说明
Pulmonary rehabilitation has been proven to benefit COPD patients in terms of quality of life and functional capabilities.
The effects of pulmonary rehabilitation (exercise) on immune function are unclear despite clear benefits of exercise on immune function in healthy individuals being identified.
Moderate-intensity and frequency of exercise has been shown to decrease the risk of upper respiratory tract infections in healthy individuals in comparison to sedentary individuals.
Respiratory infections, also known as exacerbations, in COPD are the main cause of hospitalisation and mortality.
Therefore, if exercise can modulate immune function in COPD, it can be encouraged further in COPD to reduce hospitalisation risk.
However, it is important to compare the effects of exercise amongst different phenotypes as frequent exacerbators are known to have elevated inflammatory markers, and may consequently respond to exercise differently to infrequent exacerbators, paving a rationale for a different approach to this subset of patients.
研究类型
观察性的
注册 (实际的)
85
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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Lincoln、英国、LN2 2EF
- Sudbrooke Drive Community Centre
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Lincoln、英国、LN5 8QS
- Bracebridge Community Centre
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Lincolnshire
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Lincoln、Lincolnshire、英国、LN2 2JP
- Lindum Medical Practice
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Lincoln、Lincolnshire、英国、LN2 2RS
- Nettleham Medical Practice
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Lincoln、Lincolnshire、英国、LN6 0QQ
- Birchwood Medical Practice
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Lincoln、Lincolnshire、英国、LN2 3JH
- Welton Surgery
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
40年 至 90年 (成人、年长者)
接受健康志愿者
是的
有资格学习的性别
全部
取样方法
概率样本
研究人群
116 COPD patients, confirmed by diagnosis, will be recruited (58 frequent and 58 infrequent exacerbators in accordance with criteria listed above) to the study who have been referred to, and are about to enrol, on pulmonary rehabilitation.
20 healthy smokers and 20 healthy never smokers will be recruited for baseline measurements to compare with COPD patients.
描述
Inclusion Criteria:
- 58 frequent exacerbators and 58 infrequent exacerbators (116 in total) 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%).
Exclusion Criteria:
- Inability or unwillingness to sign informed consent
- Any unstable ongoing cardiovascular events which may be exacerbated by exercise
- Inability to complete walk tests due to physical or mental impairment
- Other active inflammatory conditions e.g. rheumatoid arthritis, cancer.
- Known asthma, allergic rhinitis or other respiratory disease (bronchiectasis, pulmonary fibrosis)
Healthy control group - Patients who have not been diagnosed with COPD or any other respiratory condition and are characteristically (age (between 45-85 years old) & smoking status) matched to recruited COPD patients.
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
队列和干预
团体/队列 |
干预/治疗 |
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Frequent exacerbators
Exacerbations will be defined as "a respiratory event which led to a hospitalisation or the prescription of antibiotics and/or oral corticosteroids".
Clinicians will ask patients to retrospectively recall how many exacerbations they have had in the past 12 months.
Patients will be allocated to the frequent exacerbators group based on whether they have had 2 or more hospitalisations for exacerbations or have taken 2 or more courses on steroids/antibiotics within the past 12 months.
Blood sample collection at the following pulmonary rehabilitation sessions: 1st (pre-exercise), 2nd (pre and post-exercise), 8th (pre-exercise), last session (pre and post exercise).
Sputum samples collected pre-exercise at the following pulmonary rehabilitation sessions: 1st, 8th, and last session.
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Frequent exacerbators and infrequent exacerbators will have blood and sputum samples obtained around pulmonary rehabilitation.
No other intervention will be administered.
Healthy controls will have resting blood samples taken.
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Infrequent exacerbators
Exacerbations will be defined as "a respiratory event which led to a hospitalisation or the prescription of antibiotics and/or oral corticosteroids".
Clinicians will ask patients to retrospectively recall how many exacerbations they have had in the past 12 months.
Patients will be allocated to the infrequent exacerbators group based on whether they have had no more than 1 hospitalisation for exacerbations or have not taken more than 1 course of steroids/antibiotics within the past 12 months.
Blood sample collection at the following pulmonary rehabilitation sessions: 1st (pre-exercise), 2nd (pre and post-exercise), 8th (pre-exercise), last session (pre and post exercise).
Sputum samples collected pre-exercise at the following pulmonary rehabilitation sessions: 1st, 8th, and last session.
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Frequent exacerbators and infrequent exacerbators will have blood and sputum samples obtained around pulmonary rehabilitation.
No other intervention will be administered.
Healthy controls will have resting blood samples taken.
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Healthy smokers
Recruited in accordance with inclusion/exclusion criteria with no medical history of COPD diagnosis and currently smoke.This group will be recruited by a nurse using medical records to assess smoking status and age-matching to the COPD groups.
A resting blood sample will be taken from these patients and used to compare baseline measurements with the COPD groups.
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Frequent exacerbators and infrequent exacerbators will have blood and sputum samples obtained around pulmonary rehabilitation.
No other intervention will be administered.
Healthy controls will have resting blood samples taken.
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Healthy never smokers
Recruited in accordance with inclusion/exclusion criteria with no medical history of COPD diagnosis and have never smoked.This group will be recruited by a nurse using medical records to assess smoking status and age-matching to the COPD groups.
Resting blood samples will be taken from these patients and used to compare baseline measurements with the COPD groups.
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Frequent exacerbators and infrequent exacerbators will have blood and sputum samples obtained around pulmonary rehabilitation.
No other intervention will be administered.
Healthy controls will have resting blood samples taken.
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研究衡量的是什么？
主要结果指标
结果测量 |
大体时间 |
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Concentration of inflammatory markers in plasma and sputum (C-reactive protein, Fibrinogen, Interleukin(IL)-6, IL-8
大体时间：July 2016 - August 2018
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July 2016 - August 2018
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次要结果测量
结果测量 |
大体时间 |
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Changes in the expression of anti-inflammatory genes
大体时间：July 2016 - August 2018
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July 2016 - August 2018
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Total and differential blood leukocyte count
大体时间：July 2016 - August 2018
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July 2016 - August 2018
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Pre-activation and activation of blood neutrophils using flow cytometry
大体时间：July 2016 - August 2018
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July 2016 - August 2018
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Pro-coagulant and pro-inflammatory microparticle signatures in plasma
大体时间：July 2016 - August 2018
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July 2016 - August 2018
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Severe, moderate and mild exacerbations (number of /days to defined events, severity, recovery)
大体时间：July 2016 - August 2018
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July 2016 - August 2018
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Respiratory Symptoms™ (RS-Total score; RS-Breathlessness; RS-Cough and Sputum, and RS-Chest Symptoms)
大体时间：July 2016 - August 2018
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July 2016 - August 2018
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Routine clinical outcome measures following pulmonary rehabilitation (completion rates and clinically important differences - ISWT, ESWT, 6MWD, CRQ)
大体时间：July 2016 - August 2018
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July 2016 - August 2018
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Differences in basal levels of inflammation between frequent and infrequent exacerbators in comparison to healthy controls
大体时间：July 2016 - August 2018
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July 2016 - August 2018
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Alex R Jenkins, MPhil、PhD student
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2016年7月1日
初级完成 (实际的)
2018年8月28日
研究完成 (实际的)
2018年8月28日
研究注册日期
首次提交
2016年4月8日
首先提交符合 QC 标准的
2016年4月12日
首次发布 (估计)
2016年4月15日
研究记录更新
最后更新发布 (实际的)
2018年10月19日
上次提交的符合 QC 标准的更新
2018年10月18日
最后验证
2018年10月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.