Clinical trial NCT01388218: Non-interventional Cross-over Study to Reduce Items of PROactive Tools Measuring Physical Activity in Chronic Obstructive Pulmonary Disease (COPD)
Official title: Non-interventional Cross-over Study to Reduce Items of the Draft PROactive Tools as a Measure of Physical Activity in Daily Life in Patients With Chronic Obstructive Pulmonary Disease (COPD)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Obstructive Pulmonary Disease (COPD)
Keywords: Physical Activity
Patient Reported Outcome (PRO)
Chronic obstructive pulmonary disease (COPD)
Innovative Medicines Initiative - Joint Undertaking (IMI-JU)
Lead sponsor: Barcelona Institute for Global Health
Sponsor class: OTHER
Collaborators: name: KU Leuven
name: University of Edinburgh
name: Royal Brompton & Harefield NHS Foundation Trust
name: University Medical Center Groningen
name: University of Athens
First posted: 2011-07-06
Enrollment: 236
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CROSSOVER
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Stable COPD patients from Outpatients clinics and Primary care clinic

Exacerbated COPD patients from Inpatients

Brief summary: The purpose of the protocol is to develop final draft PRO instruments of physical activity in daily life to be used and evaluated in the further validation studies measuring physical activity in chronic obstructive pulmonary disease (COPD) patients.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of COPD (Global Initiative for Chronic Obstructive Lung Disease (GOLD) criteria: post bronchodilator forced expiratory volume in one second (FEV1)/forced vital capacity (FVC)\<70%) confirmed with spirometry in stable clinical conditions. For patients recruited during an exacerbation, the diagnosis of COPD should be confirmed in stable conditions.
* Current or ex-smokers with a smoking history equivalent to at least 10 pack years.
* Able to read and write and to use electronic devices and physical activity monitor.

Exclusion Criteria:

* Orthopaedic, neurological or other complaints that significantly impair normal biomechanical movement patterns, as judged by the investigator.
* Respiratory diseases other than COPD (e.g. asthma).
* Cognitive impairment, as judged by the investigator

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: University Hospital Gasthuisberg, Katholieke Universiteit Leuven
city: Athens
country: Greece
facility: Thorax Research Foundation
city: Groningen
country: Netherlands
facility: University Medical Center
city: London
country: United Kingdom
facility: Royal Brompton Hospital, Imperial College
state: England
city: Edinburgh
country: United Kingdom
facility: ELEGI/Colt laboratory UoE/MRC Centre for Inflammation Research The Queen's Medical Research Institute, University of Edinburgh
state: Scotland
Study officials:
affiliation: Barcelona Institute for Global Health
name: Judith Garcia-Aymerich, MD, PhD
role: STUDY_CHAIR
affiliation: AstraZeneca
name: Niklas Karlsson
role: STUDY_CHAIR
affiliation: KUL Leuven
name: Thierry Troosters
role: PRINCIPAL_INVESTIGATOR
affiliation: University Medical Center Groningen
name: Thys van der Molen
role: PRINCIPAL_INVESTIGATOR
affiliation: Imperial College London
name: Nick Hopkinson, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Edinburgh
name: Roberto Rabinovich, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Thorax Research Foundation Athens
name: Ioannis Vogiatzis, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Gimeno-Santos E, Raste Y, Demeyer H, Louvaris Z, de Jong C, Rabinovich RA, Hopkinson NS, Polkey MI, Vogiatzis I, Tabberer M, Dobbels F, Ivanoff N, de Boer WI, van der Molen T, Kulich K, Serra I, Basagana X, Troosters T, Puhan MA, Karlsson N, Garcia-Aymerich J; PROactive consortium. The PROactive instruments to measure physical activity in patients with chronic obstructive pulmonary disease. Eur Respir J. 2015 Oct;46(4):988-1000. doi: 10.1183/09031936.00183014. Epub 2015 May 28.
citation: Demeyer H, Gimeno-Santos E, Rabinovich RA, Hornikx M, Louvaris Z, de Boer WI, Karlsson N, de Jong C, Van der Molen T, Vogiatzis I, Janssens W, Garcia-Aymerich J, Troosters T, Polkey MI; PROactive consortium. Physical Activity Characteristics across GOLD Quadrants Depend on the Questionnaire Used. PLoS One. 2016 Mar 14;11(3):e0151255. doi: 10.1371/journal.pone.0151255. eCollection 2016.