Association of Physical Activity Levels and Inflammatory Markers Following Pulmonary Rehabilitation (PALI-COPD)

The Association of Physical Activity Levels and Inflammatory Markers in COPD Patients Following Pulmonary Rehabilitation

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.

Study Overview

• Status: Completed
• Conditions: COPD
• Intervention / Treatment: Other: Physical activity monitoring

• Study Type: Observational
• Enrollment (Actual): 18

Contacts and Locations

Study Locations

• United Kingdom
  • Lincolnshire
    • Lincoln, Lincolnshire, United Kingdom, LN2 2JP
      • Lindum Medical Practice
    • Lincoln, Lincolnshire, United Kingdom, LN2 2RS
      • Nettleham Medical Practice
    • Lincoln, Lincolnshire, United Kingdom, LN6 0QQ
      • Birchwood Medical Practice

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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).

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Most active; COPD patients with higher physical activity levels as defined by daily step counts.	Other: Physical activity monitoring; 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; COPD patients with lower physical activity levels as defined by daily step counts.	Other: Physical activity monitoring; COPD patients will wear an accelerometer and complete questionnaires related to daily physical activity levels for 7 days before returning for a clinic visit.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cytokines	Changes in concentration of inflammatory cytokines in the plasma of all participants using ELISA's (mg/L)	May 2018 - August 2018

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Leukocyte count	Changes in total and differential leukocyte count in all participants (10^9.L-1)	May 2018 - August 2018
Cell function	Changes in function of the following cells: myeloperoxidase, neutrophil elastase, MMP-8, MMP-9, TNF-a in the plasma of all participants using ELISA's (mg/L)	May 2018 - August 2018
Cell sensitivity to corticosteroids	Changes in cell sensitivity to corticosteroids and forskolin in all participants (expressed as fold increase from not treated samples)	May 2018 - August 2018

Collaborators and Investigators

• Sponsor: University of Lincoln
• Collaborators: National Health Service, United Kingdom

Study record dates

Study Major Dates

• Study Start (Actual): May 2, 2018
• Primary Completion (Actual): October 2, 2018
• Study Completion (Actual): October 2, 2018

Study Registration Dates

• First Submitted: February 7, 2018
• First Submitted That Met QC Criteria: February 27, 2018
• First Posted (Actual): March 6, 2018

Study Record Updates

• Last Update Posted (Actual): October 9, 2018
• Last Update Submitted That Met QC Criteria: October 8, 2018
• Last Verified: September 1, 2018

More Information

Terms related to this study

• Keywords: Pulmonary Rehabilitation; Neutrophils
• Other Study ID Numbers: 18/WM/0081

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No