Changes in Inflammatory Markers During Pulmonary Rehabilitation Based on Exacerbation States in COPD
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 85
- 试验地点
- 6
- 主要终点
- Concentration of inflammatory markers in plasma and sputum (C-reactive protein, Fibrinogen, Interleukin(IL)-6, IL-8
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 40 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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%).
排除标准
- •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.
结局指标
主要结局
Concentration of inflammatory markers in plasma and sputum (C-reactive protein, Fibrinogen, Interleukin(IL)-6, IL-8
时间窗: July 2016 - August 2018
次要结局
- Routine clinical outcome measures following pulmonary rehabilitation (completion rates and clinically important differences - ISWT, ESWT, 6MWD, CRQ)(July 2016 - August 2018)
- Respiratory Symptoms™ (RS-Total score; RS-Breathlessness; RS-Cough and Sputum, and RS-Chest Symptoms)(July 2016 - August 2018)
- Total and differential blood leukocyte count(July 2016 - August 2018)
- Pre-activation and activation of blood neutrophils using flow cytometry(July 2016 - August 2018)
- Severe, moderate and mild exacerbations (number of /days to defined events, severity, recovery)(July 2016 - August 2018)
- Changes in the expression of anti-inflammatory genes(July 2016 - August 2018)
- Pro-coagulant and pro-inflammatory microparticle signatures in plasma(July 2016 - August 2018)
- Differences in basal levels of inflammation between frequent and infrequent exacerbators in comparison to healthy controls(July 2016 - August 2018)
研究者
Alex Jenkins
Mr Alex Jenkins
University of Lincoln