COPDPALI-COPDNCT03455153
Association of Physical Activity Levels and Inflammatory Markers Following Pulmonary Rehabilitation
An observational study of COPD, run by University of Lincoln at 3 sites in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 40 to 90 years
- Conditions the study is for
- COPD
- What is being tested?
- Physical activity monitoring
- How many people
- 18 participants
- Where
- 3 sitesUnited Kingdom
- Study dates
- 2 May 2018to 2 Oct 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: COPD patients who have enrolled on pulmonary rehabilitation and took part in the initial CIMPRES-COPD study.
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
3 sites in 1 country.
United Kingdom3 sites
Lindum Medical Practice
Lincoln, Lincolnshire, LN2 2JP
Nettleham Medical Practice
Lincoln, Lincolnshire, LN2 2RS
Birchwood Medical Practice
Lincoln, Lincolnshire, LN6 0QQ
About this study
Official title: 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.
- Conditions
- COPD
- Being tested
- Physical activity monitoring
- Keywords
- Pulmonary Rehabilitation, Neutrophils
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical activity monitoringOther
COPD patients will wear an accelerometer and complete questionnaires related to daily physical activity levels for 7 days before returning for a clinic visit.
| Study group | Role | What they receive |
|---|---|---|
| Most active | COPD patients with higher physical activity levels as defined by daily step counts. Receives: Other: Physical activity monitoring | |
| Least active | COPD patients with lower physical activity levels as defined by daily step counts. Receives: Other: Physical activity monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cytokines
Changes in concentration of inflammatory cytokines in the plasma of all participants using ELISA's (mg/L)
Measured: May 2018 - August 2018
Secondary outcomes (3)
Leukocyte count
Changes in total and differential leukocyte count in all participants (10^9.L-1)
Measured: 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)
Measured: 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)
Measured: May 2018 - August 2018
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2018
- Study start2 May 2018
- Primary completion2 Oct 2018
- Study completion2 Oct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COPDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Lincoln
- Sponsor type
- University, hospital or other
- Collaborators
- National Health Service, United Kingdom
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03455153
- Sponsor's protocol ID
- 18/WM/0081
- Acronym
- PALI-COPD
- Status last verified
- Sep 2018
- First submitted
- 7 Feb 2018
- Last updated
- 9 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Association of Physical Activity Levels and Inflammatory Markers in COPD Patients Following Pulmonary Rehabilitation
- ClinicalTrials.gov ID
- NCT03455153
- Acronym / sponsor ID
- PALI-COPD / 18/WM/0081
- Conditions
- COPD
- Keywords
- Pulmonary Rehabilitation, Neutrophils
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- University of LincolnUniversity, hospital or other
- Collaborators
- National Health Service, United Kingdom
- Study start
- 2 May 2018 (actual)
- Primary completion
- 2 Oct 2018 (actual)
- Study completion
- 2 Oct 2018 (actual)
- First posted
- 6 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Most active | – | Other: Physical activity monitoringCOPD patients with higher physical activity levels as defined by daily step counts. |
| Least active | – | Other: Physical activity monitoringCOPD patients with lower physical activity levels as defined by daily step counts. |
Who may qualify
- Ages
- 40 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- COPD patients who have enrolled on pulmonary rehabilitation and took part in the initial CIMPRES-COPD study.
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (3 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Physical activity monitoringCOPD patients will wear an accelerometer and complete questionnaires related to daily physical activity levels for 7 days before returning for a clinic visit. | Other | Least active, Most active |
Primary outcome
Cytokines
Time frame: May 2018 - August 2018
Changes in concentration of inflammatory cytokines in the plasma of all participants using ELISA's (mg/L)
3 secondary outcomes
Leukocyte count
Time frame: May 2018 - August 2018
Cell function
Time frame: May 2018 - August 2018
Cell sensitivity to corticosteroids
Time frame: May 2018 - August 2018
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COPD, run by University of Lincoln at 3 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cytokines (time frame: May 2018 - August 2018). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Oct 2018.