NCT03157817

Brief Summary

Investigation into the associations between sedentary behaviour, physical activity, body composition and cardiometabolic risk in COPD. A single assessment visit with fasting blood tests, body composition and strength measures followed by a week of activity monitor wear to record sitting time and physical activity. Cardiometabolic risk markers include fasting glucose, HBA1c, HOMA and lipids and blood pressure.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2016

Shorter than P25 for all trials

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 18, 2016

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

May 15, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 17, 2017

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 15, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 15, 2017

Completed
Last Updated

September 1, 2017

Status Verified

August 1, 2017

Enrollment Period

10 months

First QC Date

May 15, 2017

Last Update Submit

August 31, 2017

Conditions

Outcome Measures

Primary Outcomes (1)

  • cardiometabolic risk

    aggregated measure based on lipid levels, fasting glucose, glycated haemoglobin (A1c) (HbA1c), homeostatic model assessment (HOMA) and blood pressure

    baseline

Study Arms (2)

Chronic Obstructive Pulmonary Disease

Patients with a diagnosis of Chronic Obstructive Pulmonary Disease

Healthy Volunteers

Volunteers without any respiratory condition or symptoms

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Those with COPD recruited from both secondary care and an existing primary care database. Healthy volunteers recruited from an existing database recruited through community advertisement.

You may qualify if:

  • People with COPD or healthy volunteers without any respiratory conditions
  • Over age of 40
  • Body Mass Index below 35

You may not qualify if:

  • Age below 40
  • BMI above 35
  • Unable to complete assessment visit

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Respiratory Biomedical Research Centre

Leicester, Leicestershire, LE3 9QP, United Kingdom

Location

Loughborough Universtiy

Loughborough, Leicestershire, LE11 3TU, United Kingdom

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Target Duration
1 Week
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 15, 2017

First Posted

May 17, 2017

Study Start

October 18, 2016

Primary Completion

August 15, 2017

Study Completion

August 15, 2017

Last Updated

September 1, 2017

Record last verified: 2017-08

Data Sharing

IPD Sharing
Will not share

Available on request from Ruth Trethewey

Locations