Changes in Inflammatory Markers During Pulmonary Rehabilitation Based on Exacerbation States in COPD (CIMPRES-COPD)
18 oktober 2018 uppdaterad av: 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.
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Observationell
Inskrivning (Faktisk)
85
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
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Lincoln, Storbritannien, LN2 2EF
- Sudbrooke Drive Community Centre
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Lincoln, Storbritannien, LN5 8QS
- Bracebridge Community Centre
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Lincolnshire
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Lincoln, Lincolnshire, Storbritannien, LN2 2JP
- Lindum Medical Practice
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Lincoln, Lincolnshire, Storbritannien, LN2 2RS
- Nettleham Medical Practice
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Lincoln, Lincolnshire, Storbritannien, LN6 0QQ
- Birchwood Medical Practice
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Lincoln, Lincolnshire, Storbritannien, LN2 3JH
- Welton Surgery
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Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
40 år till 90 år (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Ja
Kön som är behöriga för studier
Allt
Testmetod
Sannolikhetsprov
Studera befolkning
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.
Beskrivning
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.
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
Kohorter och interventioner
Grupp / Kohort |
Intervention / Behandling |
|---|---|
|
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.
|
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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Vad mäter studien?
Primära resultatmått
Resultatmått |
Tidsram |
|---|---|
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Concentration of inflammatory markers in plasma and sputum (C-reactive protein, Fibrinogen, Interleukin(IL)-6, IL-8
Tidsram: July 2016 - August 2018
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July 2016 - August 2018
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Sekundära resultatmått
Resultatmått |
Tidsram |
|---|---|
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Changes in the expression of anti-inflammatory genes
Tidsram: July 2016 - August 2018
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July 2016 - August 2018
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Total and differential blood leukocyte count
Tidsram: 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
Tidsram: 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
Tidsram: 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)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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
Tidsram: July 2016 - August 2018
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July 2016 - August 2018
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Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Samarbetspartners
Utredare
- Huvudutredare: Alex R Jenkins, MPhil, PhD student
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart
1 juli 2016
Primärt slutförande (Faktisk)
28 augusti 2018
Avslutad studie (Faktisk)
28 augusti 2018
Studieregistreringsdatum
Först inskickad
8 april 2016
Först inskickad som uppfyllde QC-kriterierna
12 april 2016
Första postat (Uppskatta)
15 april 2016
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
19 oktober 2018
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
18 oktober 2018
Senast verifierad
1 oktober 2018
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 16/LO/0865
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
NEJ
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