Association of Physical Activity Levels and Inflammatory Markers Following Pulmonary Rehabilitation

COPD Clinical Trial

— PALI-COPD  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03455153
• Other study ID #: 18/WM/0081
• Status: Completed
• Start date: May 2, 2018
• Est. completion date: October 2, 2018

Study information

• Verified date: September 2018
• Source: University of Lincoln
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: October 2, 2018
• Est. primary completion date: October 2, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 90 Years

Eligibility

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).

Related Conditions & MeSH terms

• COPD

Intervention

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.

Locations

Country	Name	City	State
United Kingdom	Birchwood Medical Practice	Lincoln	Lincolnshire
United Kingdom	Lindum Medical Practice	Lincoln	Lincolnshire
United Kingdom	Nettleham Medical Practice	Lincoln	Lincolnshire

Sponsors (2)

Lead Sponsor	Collaborator
University of Lincoln	National Health Service, United Kingdom

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cytokines	Changes in concentration of inflammatory cytokines in the plasma of all participants using ELISA's (mg/L)	May 2018 - August 2018
Secondary	Leukocyte count	Changes in total and differential leukocyte count in all participants (10^9.L-1)	May 2018 - August 2018
Secondary	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
Secondary	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