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OpenTrials
Completed

NCT Number: NCT03455153

Association of Physical Activity Levels and Inflammatory Markers 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.

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Key information

Age range

40 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Birchwood Medical Practice, Lincoln, Lincolnshire, United Kingdom

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

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.

Primary outcomes

  1. Cytokines

    Time frame: May 2018 - August 2018

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

Secondary outcomes

  1. Leukocyte count

    Time frame: May 2018 - August 2018

    Changes in total and differential leukocyte count in all participants (10^9.L-1)

  2. Cell function

    Time frame: May 2018 - August 2018

    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)

  3. Cell sensitivity to corticosteroids

    Time frame: May 2018 - August 2018

    Changes in cell sensitivity to corticosteroids and forskolin in all participants (expressed as fold increase from not treated samples)

Sponsors and collaborators

Lead sponsor

University of Lincoln

Other

Collaborators

  • National Health Service, United Kingdom

Registry information

Official study title

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

Acronym: PALI-COPD

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Mar 6, 2018
Registry last updated
Oct 9, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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