Changes in Inflammatory Markers During Pulmonary Rehabilitation Based on Exacerbation States in COPD (CIMPRES-COPD)
18 oktober 2018 bijgewerkt door: 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.
Studie Overzicht
Toestand
Voltooid
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
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.
Studietype
Observationeel
Inschrijving (Werkelijk)
85
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studie Locaties
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Lincoln, Verenigd Koninkrijk, LN2 2EF
- Sudbrooke Drive Community Centre
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Lincoln, Verenigd Koninkrijk, LN5 8QS
- Bracebridge Community Centre
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Lincolnshire
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Lincoln, Lincolnshire, Verenigd Koninkrijk, LN2 2JP
- Lindum Medical Practice
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Lincoln, Lincolnshire, Verenigd Koninkrijk, LN2 2RS
- Nettleham Medical Practice
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Lincoln, Lincolnshire, Verenigd Koninkrijk, LN6 0QQ
- Birchwood Medical Practice
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Lincoln, Lincolnshire, Verenigd Koninkrijk, LN2 3JH
- Welton Surgery
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Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
40 jaar tot 90 jaar (Volwassen, Oudere volwassene)
Accepteert gezonde vrijwilligers
Ja
Geslachten die in aanmerking komen voor studie
Allemaal
Bemonsteringsmethode
Kanssteekproef
Studie Bevolking
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.
Beschrijving
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.
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
Cohorten en interventies
Groep / Cohort |
Interventie / Behandeling |
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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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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
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Concentration of inflammatory markers in plasma and sputum (C-reactive protein, Fibrinogen, Interleukin(IL)-6, IL-8
Tijdsspanne: July 2016 - August 2018
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July 2016 - August 2018
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Secundaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
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Changes in the expression of anti-inflammatory genes
Tijdsspanne: July 2016 - August 2018
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July 2016 - August 2018
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Total and differential blood leukocyte count
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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
Tijdsspanne: July 2016 - August 2018
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July 2016 - August 2018
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Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Sponsor
Medewerkers
Onderzoekers
- Hoofdonderzoeker: Alex R Jenkins, MPhil, PhD student
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start
1 juli 2016
Primaire voltooiing (Werkelijk)
28 augustus 2018
Studie voltooiing (Werkelijk)
28 augustus 2018
Studieregistratiedata
Eerst ingediend
8 april 2016
Eerst ingediend dat voldeed aan de QC-criteria
12 april 2016
Eerst geplaatst (Schatting)
15 april 2016
Updates van studierecords
Laatste update geplaatst (Werkelijk)
19 oktober 2018
Laatste update ingediend die voldeed aan QC-criteria
18 oktober 2018
Laatst geverifieerd
1 oktober 2018
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- 16/LO/0865
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
NEE
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