Clinical trial NCT03455153: Association of Physical Activity Levels and Inflammatory Markers Following Pulmonary Rehabilitation
Official title: The Association of Physical Activity Levels and Inflammatory Markers in COPD Patients Following Pulmonary Rehabilitation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: COPD
Keywords: Pulmonary Rehabilitation
Neutrophils
Lead sponsor: University of Lincoln
Sponsor class: OTHER
Collaborators: name: National Health Service, United Kingdom
First posted: 2018-03-06
Enrollment: 18
Sex: ALL
Minimum age (years): 40
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: COPD patients who have enrolled on pulmonary rehabilitation and took part in the initial CIMPRES-COPD study.

Brief summary: 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.


Eligibility criteria: 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).

Primary outcomes:
measure: Cytokines
timeFrame: May 2018 - August 2018
Secondary outcomes:
measure: Leukocyte count
timeFrame: May 2018 - August 2018
measure: Cell function
timeFrame: May 2018 - August 2018
measure: Cell sensitivity to corticosteroids
timeFrame: May 2018 - August 2018
Other outcomes:
Locations:
city: Lincoln
country: United Kingdom
facility: Lindum Medical Practice
state: Lincolnshire
city: Lincoln
country: United Kingdom
facility: Nettleham Medical Practice
state: Lincolnshire
city: Lincoln
country: United Kingdom
facility: Birchwood Medical Practice
state: Lincolnshire
Study officials:
References: