NCT01388218

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.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
236

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2011

Geographic Reach
4 countries

5 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

July 1, 2011

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

July 4, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 6, 2011

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
Last Updated

April 27, 2018

Status Verified

July 1, 2015

Enrollment Period

5 months

First QC Date

July 4, 2011

Last Update Submit

April 26, 2018

Conditions

Chronic Obstructive Pulmonary Disease (COPD)

Keywords

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

Study Arms (2)

Arm 1 - Daily+Clinical

Order of assessment: Daily PRO + Clinical visit PRO

Arm 2 - Clinical+Daily

Order of assessment: Clinical visit PRO + Daily PRO

Eligibility Criteria

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

Stable COPD patients from Outpatients clinics and Primary care clinic Exacerbated COPD patients from Inpatients

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

University Hospital Gasthuisberg, Katholieke Universiteit Leuven

Leuven, 3000, Belgium

Location

Thorax Research Foundation

Athens, Greece

Location

University Medical Center

Groningen, Netherlands

Location

Royal Brompton Hospital, Imperial College

London, England, SW3 6NP, United Kingdom

Location

ELEGI/Colt laboratory UoE/MRC Centre for Inflammation Research The Queen's Medical Research Institute, University of Edinburgh

Edinburgh, Scotland, EH16 4TJ, United Kingdom

Location

Related Publications (2)

  • 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.

    PMID: 26022965RESULT

  • 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.

    PMID: 26974332DERIVED

Related Links

MeSH Terms

Conditions

Pulmonary Disease, Chronic ObstructiveMotor Activity

Condition Hierarchy (Ancestors)

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

Study Officials

  • Judith Garcia-Aymerich, MD, PhD

    Barcelona Institute for Global Health

    STUDY CHAIR

  • Niklas Karlsson

    AstraZeneca

    STUDY CHAIR

  • Thierry Troosters

    KUL Leuven

    PRINCIPAL INVESTIGATOR

  • Thys van der Molen

    University Medical Center Groningen

    PRINCIPAL INVESTIGATOR

  • Nick Hopkinson, MD

    Imperial College London

    PRINCIPAL INVESTIGATOR

  • Roberto Rabinovich, MD, PhD

    University of Edinburgh

    PRINCIPAL INVESTIGATOR

  • Ioannis Vogiatzis, PhD

    Thorax Research Foundation Athens

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CROSSOVER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 4, 2011

First Posted

July 6, 2011

Study Start

July 1, 2011

Primary Completion

December 1, 2011

Study Completion

December 1, 2012

Last Updated

April 27, 2018

Record last verified: 2015-07

Locations

GB(2)GR(1)BE(1)NL(1)