Association of Physical Activity Levels and Inflammatory Markers Following Pulmonary Rehabilitation

Study Overview
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Brief Summary
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COPD is characterised by irreversible airflow limitation that is usually progressive and associated with an enhanced chronic inflammatory response. This inflammation can be amplified with flare-ups that are commonly seen in COPD patients. Pulmonary rehabilitation is one of the most effective methods of managing chronic obstructive pulmonary disease (COPD). Pulmonary rehabilitation has been seen to induce improvements in functional capacity and quality. In healthy individuals, exercise has been shown to induce an anti-inflammatory response when performed regularly. However, the effects of exercise on inflammation in COPD are unclear. Our initial CIMPRES-COPD study has looked into the effects of short-term exercise, as part of pulmonary rehabilitation, on inflammation. However, this trial will examine the inflammatory response in COPD patients who are most active following pulmonary rehabilitation against those who are least active. This study will split participants into 2 groups according to physical activity level following pulmonary rehabilitation. We will recruit 40 COPD patients who provided a sample in the initial CIMPRES-COPD study to explore inflammatory responses in those who are most active and least active. By better understanding the mechanisms of how long-term physical activity levels affects inflammation in COPD, we could design better interventions to increase physical activity levels following pulmonary rehabilitation.

Official Title
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The Association of Physical Activity Levels and Inflammatory Markers in COPD Patients Following Pulmonary Rehabilitation

Conditions
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COPD

Intervention / Treatment
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* Other: Physical activity monitoring


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients diagnosed with any severity of COPD (according to British Thoracic Society criteria, i.e. >10 pack year smoking history and post bronchodilator spirometry FEV1/FVC ratio <0.70 and FEV<80%) Previously enrolled on pulmonary rehabilitation providing at least one sample for the CIMPRES-COPD trial. Exclusion Criteria: Any unstable ongoing cardiovascular events. Other active inflammatory conditions (e.g. rheumatoid arthritis, cancer). Known asthma, allergic rhinitis or other respiratory disease (bronchiectasis, pulmonary fibrosis).

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Most active<br>COPD patients with higher physical activity levels as defined by daily step counts. | Other: Physical activity monitoring<br>* COPD patients will wear an accelerometer and complete questionnaires related to daily physical activity levels for 7 days before returning for a clinic visit.<br>|
| Least active<br>COPD patients with lower physical activity levels as defined by daily step counts. | Other: Physical activity monitoring<br>* COPD patients will wear an accelerometer and complete questionnaires related to daily physical activity levels for 7 days before returning for a clinic visit.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cytokines | Changes in concentration of inflammatory cytokines in the plasma of all participants using ELISA's (mg/L) | May 2018 - August 2018 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Leukocyte count | Changes in total and differential leukocyte count in all participants (10^9.L-1) | May 2018 - August 2018 | 
| Cell function | Changes in function of the following cells: myeloperoxidase, neutrophil elastase, MMP-8, MMP-9, TNF-a in the plasma of all participants using ELISA's (mg/L) | May 2018 - August 2018 | 
| Cell sensitivity to corticosteroids | Changes in cell sensitivity to corticosteroids and forskolin in all participants (expressed as fold increase from not treated samples) | May 2018 - August 2018 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pulmonary Rehabilitation, Neutrophils