Association of Physical Activity Levels and Inflammatory Markers Following Pulmonary Rehabilitation

NCT ID: NCT03455153

Last Updated: 2018-10-09

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 18 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-05-02
• Study Completion Date: 2018-10-02

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Most active

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

Physical activity monitoring

Intervention Type: 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

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

Physical activity monitoring

Intervention Type: 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.

Interventions

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.

Intervention Type: OTHER

Eligibility 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).

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Health Service, United Kingdom

OTHER_GOV

Sponsor Role: collaborator

University of Lincoln

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Lindum Medical Practice

Lincoln, Lincolnshire, United Kingdom

Nettleham Medical Practice

Lincoln, Lincolnshire, United Kingdom

Birchwood Medical Practice

Lincoln, Lincolnshire, United Kingdom

Countries

United Kingdom

Other Identifiers

18/WM/0081

Identifier Type: -

Identifier Source: org_study_id