Changes in Inflammatory Markers During Pulmonary Rehabilitation Based on Exacerbation States in COPD (CIMPRES-COPD)
18 de octubre de 2018 actualizado por: 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.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Descripción detallada
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.
Tipo de estudio
De observación
Inscripción (Actual)
85
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
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Lincoln, Reino Unido, LN2 2EF
- Sudbrooke Drive Community Centre
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Lincoln, Reino Unido, LN5 8QS
- Bracebridge Community Centre
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Lincolnshire
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Lincoln, Lincolnshire, Reino Unido, LN2 2JP
- Lindum Medical Practice
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Lincoln, Lincolnshire, Reino Unido, LN2 2RS
- Nettleham Medical Practice
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Lincoln, Lincolnshire, Reino Unido, LN6 0QQ
- Birchwood Medical Practice
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Lincoln, Lincolnshire, Reino Unido, LN2 3JH
- Welton Surgery
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
40 años a 90 años (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
Sí
Géneros elegibles para el estudio
Todos
Método de muestreo
Muestra de probabilidad
Población de estudio
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.
Descripción
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.
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
Intervención / Tratamiento |
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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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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
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Concentration of inflammatory markers in plasma and sputum (C-reactive protein, Fibrinogen, Interleukin(IL)-6, IL-8
Periodo de tiempo: July 2016 - August 2018
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July 2016 - August 2018
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Medidas de resultado secundarias
Medida de resultado |
Periodo de tiempo |
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Changes in the expression of anti-inflammatory genes
Periodo de tiempo: July 2016 - August 2018
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July 2016 - August 2018
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Total and differential blood leukocyte count
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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
Periodo de tiempo: July 2016 - August 2018
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July 2016 - August 2018
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Alex R Jenkins, MPhil, PhD student
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio
1 de julio de 2016
Finalización primaria (Actual)
28 de agosto de 2018
Finalización del estudio (Actual)
28 de agosto de 2018
Fechas de registro del estudio
Enviado por primera vez
8 de abril de 2016
Primero enviado que cumplió con los criterios de control de calidad
12 de abril de 2016
Publicado por primera vez (Estimar)
15 de abril de 2016
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
19 de octubre de 2018
Última actualización enviada que cumplió con los criterios de control de calidad
18 de octubre de 2018
Última verificación
1 de octubre de 2018
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 16/LO/0865
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
NO
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .
Ensayos clínicos sobre Sample collection
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Hillel Yaffe Medical CenterDesconocido
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Cliniques universitaires Saint-Luc- Université...Université de LiègeReclutamientoFibrosis quística | BiomarcadoresBélgica