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

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ClinicalTrials.gov Identifier: NCT03455153
Recruitment Status : Not yet recruiting
First Posted : March 6, 2018
Last Update Posted : March 20, 2018
Sponsor:
Collaborator:
National Health Service, United Kingdom
Information provided by (Responsible Party):
University of Lincoln

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.


Condition or disease Intervention/treatment
COPD Other: Physical activity monitoring

Study Type : Observational
Estimated Enrollment : 40 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Association of Physical Activity Levels and Inflammatory Markers in COPD Patients Following Pulmonary Rehabilitation
Estimated Study Start Date : May 2018
Estimated Primary Completion Date : August 2018
Estimated Study Completion Date : August 2018

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. Neutrophil activation [ Time Frame: May 2018 - August 2018 ]
    Activation of blood neutrophils using flow cytometry in all participants (expressed as mean & median fluorescent intensity


Secondary Outcome Measures :
  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. Cytokines [ Time Frame: May 2018 - August 2018 ]
    Changes in concentration of inflammatory cytokines in the plasma of all participants using ELISA's (mg/L)

  4. 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)


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.


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Ages Eligible for Study:   40 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
COPD patients who have enrolled on pulmonary rehabilitation and took part in the initial CIMPRES-COPD study.
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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03455153


Contacts
Contact: Alex R Jenkins, MPhil 01522 835360 ext +44 aljenkins@lincoln.ac.uk
Contact: Arwel W Jones, PhD 01522 886451 arjones@lincoln.ac.uk

Sponsors and Collaborators
University of Lincoln
National Health Service, United Kingdom

Responsible Party: University of Lincoln
ClinicalTrials.gov Identifier: NCT03455153     History of Changes
Other Study ID Numbers: 18/WM/0081
First Posted: March 6, 2018    Key Record Dates
Last Update Posted: March 20, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University of Lincoln:
Pulmonary Rehabilitation
Neutrophils