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| Name | Class |
|---|---|
| National Health Service, United Kingdom | OTHER_GOV |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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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| 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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| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sample collection | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Concentration of inflammatory markers in plasma and sputum (C-reactive protein, Fibrinogen, Interleukin(IL)-6, IL-8 | July 2016 - August 2018 |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in the expression of anti-inflammatory genes | July 2016 - August 2018 | |
| Total and differential blood leukocyte count | July 2016 - August 2018 | |
| Pre-activation and activation of blood neutrophils using flow cytometry |
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Inclusion Criteria:
Exclusion Criteria:
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.
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Alex R Jenkins, MPhil | PhD student | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lindum Medical Practice | Lincoln | Lincolnshire | LN2 2JP | United Kingdom | ||
| Nettleham Medical Practice |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | May 6, 2021 | |
| Reset | Jun 1, 2021 | |
| Release | Sep 30, 2021 |
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Whole blood samples will be used on the day of collection and analysed before being appropriately disposed of on the same day. Blood samples will be centrifuged with separated plasma to be frozen at -80c for later analysis of cellular content. Sputum samples will also be centrifuged with supernatant extracted and frozen -80c for later analysis.
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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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| July 2016 - August 2018 |
| Pro-coagulant and pro-inflammatory microparticle signatures in plasma | July 2016 - August 2018 |
| Severe, moderate and mild exacerbations (number of /days to defined events, severity, recovery) | July 2016 - August 2018 |
| Respiratory Symptoms™ (RS-Total score; RS-Breathlessness; RS-Cough and Sputum, and RS-Chest Symptoms) | July 2016 - August 2018 |
| Routine clinical outcome measures following pulmonary rehabilitation (completion rates and clinically important differences - ISWT, ESWT, 6MWD, CRQ) | July 2016 - August 2018 |
| Differences in basal levels of inflammation between frequent and infrequent exacerbators in comparison to healthy controls | July 2016 - August 2018 |
| Lincoln |
| Lincolnshire |
| LN2 2RS |
| United Kingdom |
| Welton Surgery | Lincoln | Lincolnshire | LN2 3JH | United Kingdom |
| Birchwood Medical Practice | Lincoln | Lincolnshire | LN6 0QQ | United Kingdom |
| Sudbrooke Drive Community Centre | Lincoln | LN2 2EF | United Kingdom |
| Bracebridge Community Centre | Lincoln | LN5 8QS | United Kingdom |
| Reset | Oct 27, 2021 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| May 6, 2021 | Jun 1, 2021 | |||
| Sep 30, 2021 | Oct 27, 2021 |
| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| D009043 | Motor Activity |
| D007249 | Inflammation |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D013048 | Specimen Handling |
| ID | Term |
|---|---|
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D008919 | Investigative Techniques |
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