Association of Physical Activity Levels and Inflammatory Markers Following Pulmonary Rehabilitation

NCT03455153 | Completed

• 1 other identifier: 18/WM/0081
• Study Type: observational
• Target: 18
• Locations: 1 country
• Sites: 3

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.

Conditions

COPD

Keywords

Pulmonary Rehabilitation; Neutrophils

Outcome Measures

Primary Outcomes (1)

• Cytokines

  Changes in concentration of inflammatory cytokines in the plasma of all participants using ELISA's (mg/L)

  May 2018 - August 2018

Secondary Outcomes (3)

• Leukocyte count

  May 2018 - August 2018

• Cell function

  May 2018 - August 2018

• Cell sensitivity to corticosteroids

  May 2018 - August 2018

Study Arms (2)

Most active

COPD patients with higher physical activity levels as defined by daily step counts.

Other: Physical activity monitoring

Least active

COPD patients with lower physical activity levels as defined by daily step counts.

Other: Physical activity monitoring

Interventions

Physical activity monitoring OTHER

COPD patients will wear an accelerometer and complete questionnaires related to daily physical activity levels for 7 days before returning for a clinic visit.

Least active; Most active

Eligibility Criteria

• Age: 40 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

COPD patients who have enrolled on pulmonary rehabilitation and took part in the initial CIMPRES-COPD study.

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• University of Lincoln: lead
• National Health Service, United Kingdom: collaborator

Study Sites (3)

Lindum Medical Practice

Lincoln, Lincolnshire, LN2 2JP, United Kingdom

Location

Nettleham Medical Practice

Lincoln, Lincolnshire, LN2 2RS, United Kingdom

Location

Birchwood Medical Practice

Lincoln, Lincolnshire, LN6 0QQ, United Kingdom

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

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 acellular plasma to be frozen at -80c for later analysis of cellular content.

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 7, 2018
• First Posted: March 6, 2018
• Study Start: May 2, 2018
• Primary Completion: October 2, 2018
• Study Completion: October 2, 2018
• Last Updated: October 9, 2018

Record last verified: 2018-09

Data Sharing

• IPD Sharing: Will not share

Locations

GB (3)