CompletedNCT01388218Updated Apr 27, 2018

Non-interventional Cross-over Study to Reduce Items of PROactive Tools Measuring Physical Activity in Chronic Obstructive Pulmonary Disease (COPD)

An observational study in Chronic Obstructive Pulmonary Disease (COPD), sponsored by Barcelona Institute for Global Health. Completed at 5 sites in 4 countries. Open to participants aged 40 Years and older. Per ClinicalTrials.gov, last updated 2018-04-27.

Sponsored by Barcelona Institute for Global Health · Observational

Study type: Observational
Model: Case-crossover
Time perspective: Cross-sectional
Enrollment: 236
Ages: 40 Years and older
Sex: All

Study 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.

Conditions studied

Chronic Obstructive Pulmonary Disease (COPD)

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Keywords

Physical Activity
Patient Reported Outcome (PRO)
Chronic obstructive pulmonary disease (COPD)
Innovative Medicines Initiative - Joint Undertaking (IMI-JU)

In context

Lung Diseases

3,303 studies on the registry are indexed under Lung Diseases; 355 are open to participants now.

This study's enrollment of 236 is above the median of 157 across 929 observational studies indexed under Lung Diseases.

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Lead sponsor

Barcelona Institute for Global Health is the lead sponsor of 24 studies on the registry; 5 are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 40 Years and older
Sexes eligible: All
Accepts healthy volunteers: No
Sampling method: Probability sample

Study population

Stable COPD patients from Outpatients clinics and Primary care clinic

Exacerbated COPD patients from Inpatients

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

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

Study design

Observational model: Case-crossover
Time perspective: Cross-sectional
Enrollment: 236 participants (actual)

Groups and cohorts

Arm 1 - Daily+Clinical
Order of assessment: Daily PRO + Clinical visit PRO
Arm 2 - Clinical+Daily
Order of assessment: Clinical visit PRO + Daily PRO

Study locations

5 sites

University Hospital Gasthuisberg, Katholieke Universiteit Leuven
Leuven, 3000, Belgium
Thorax Research Foundation
Athens, Greece
University Medical Center
Groningen, Netherlands
Royal Brompton Hospital, Imperial College
London, England SW3 6NP, United Kingdom
ELEGI/Colt laboratory UoE/MRC Centre for Inflammation Research The Queen's Medical Research Institute, University of Edinburgh
Edinburgh, Scotland EH16 4TJ, United Kingdom

References and documents

Publications

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. PubMed 26022965 ↗
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. PubMed 26974332 ↗

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Apr 27, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT01388218
Lead sponsor: Barcelona Institute for Global Health
Collaborators: KU Leuven, University of Edinburgh, Royal Brompton & Harefield NHS Foundation Trust, University Medical Center Groningen, University of Athens
Responsible party: Sponsor
First posted: Jul 6, 2011
Start date: Jul 2011
Primary completion: Dec 2011
Completion: Dec 2012
Last update: Apr 27, 2018

Study contacts

Judith Garcia-Aymerich, MD, PhD

study chair · Barcelona Institute for Global Health

Niklas Karlsson

study chair · AstraZeneca

Thierry Troosters

principal investigator · KUL Leuven

Thys van der Molen

principal investigator · University Medical Center Groningen

Nick Hopkinson, MD

principal investigator · Imperial College London

Roberto Rabinovich, MD, PhD

principal investigator · University of Edinburgh

Ioannis Vogiatzis, PhD

principal investigator · Thorax Research Foundation Athens

Oversight

Data monitoring committee: Yes

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2015. You cannot join it, but the record below documents what was studied.

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