Association of Physical Activity Levels and Inflammatory... | NCT03455153

Studies
Association of Physical Activity Levels and Inflammatory Markers Following Pulmonary Rehabilitation

NCT03455153

Sponsor

University of Lincoln

Status

Completed

Last Update Posted

Oct 9, 2018Actual

Enrollment

18Actual

Phase

Not provided

Conditions

COPD

Interventions

Physical activity monitoring

Countries

United Kingdom

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2, 2018Actual

Primary Completion Date

Oct 2, 2018Actual

Completion Date

Oct 2, 2018Actual

First Submitted Date

Feb 7, 2018

First Submission Date that Met QC Criteria

Feb 27, 2018

First Posted Date

Mar 6, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 8, 2018

Last Update Posted Date

Oct 9, 2018Actual

Name	Class
National Health Service, United Kingdom	OTHER_GOV

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

18Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Most active		COPD patients with higher physical activity levels as defined by daily step counts.	Other: Physical activity monitoring
Least active		COPD patients with lower physical activity levels as defined by daily step counts.	Other: Physical activity monitoring

Interventions

Name	Type	Description	Arm Group Labels	Other Names
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.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Cytokines	Changes in concentration of inflammatory cytokines in the plasma of all participants using ELISA's (mg/L)	May 2018 - August 2018

Secondary Outcomes

Measure	Description	Time Frame
Leukocyte count	Changes in total and differential leukocyte count in all participants (10^9.L-1)	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)

Other Outcomes

Not provided

Eligibility Module

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).

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

40 Years

Maximum Age

90 Years

Standard Ages

AdultOlder Adult

Study Population

COPD patients who have enrolled on pulmonary rehabilitation and took part in the initial CIMPRES-COPD study.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Lindum Medical Practice		Lincoln	Lincolnshire	LN2 2JP	United Kingdom
Nettleham Medical Practice

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D029424	Pulmonary Disease, Chronic Obstructive

Ancestor Terms

ID	Term
D008173	Lung Diseases, Obstructive
D008171	Lung Diseases
D012140	Respiratory Tract Diseases
D002908	Chronic Disease

Browse Leaves

Not provided

Browse Branches

Not provided

Description

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.