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

NCT ID: NCT01388218

Last Updated: 2018-04-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

236 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-07-31

Study Completion Date

2012-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Chronic Obstructive Pulmonary Disease (COPD)

Study Design

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Observational Model Type

CASE_CROSSOVER

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Arm 1 - Daily+Clinical

Order of assessment: Daily PRO + Clinical visit PRO

No interventions assigned to this group

Arm 2 - Clinical+Daily

Order of assessment: Clinical visit PRO + Daily PRO

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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KU Leuven

OTHER

Sponsor Role collaborator

University of Edinburgh

OTHER

Sponsor Role collaborator

Royal Brompton & Harefield NHS Foundation Trust

OTHER

Sponsor Role collaborator

University Medical Center Groningen

OTHER

Sponsor Role collaborator

University of Athens

OTHER

Sponsor Role collaborator

Barcelona Institute for Global Health

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Judith Garcia-Aymerich, MD, PhD

Role: STUDY_CHAIR

Barcelona Institute for Global Health

Niklas Karlsson

Role: STUDY_CHAIR

AstraZeneca

Thierry Troosters

Role: PRINCIPAL_INVESTIGATOR

KUL Leuven

Thys van der Molen

Role: PRINCIPAL_INVESTIGATOR

University Medical Center Groningen

Nick Hopkinson, MD

Role: PRINCIPAL_INVESTIGATOR

Imperial College London

Roberto Rabinovich, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Edinburgh

Ioannis Vogiatzis, PhD

Role: PRINCIPAL_INVESTIGATOR

Thorax Research Foundation Athens

Locations

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University Hospital Gasthuisberg, Katholieke Universiteit Leuven

Leuven, , Belgium

Site Status

Thorax Research Foundation

Athens, , Greece

Site Status

University Medical Center

Groningen, , Netherlands

Site Status

Royal Brompton Hospital, Imperial College

London, England, United Kingdom

Site Status

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

Edinburgh, Scotland, United Kingdom

Site Status

Countries

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Belgium Greece Netherlands United Kingdom

References

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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.

Reference Type RESULT
PMID: 26022965 (View on PubMed)

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.

Reference Type DERIVED
PMID: 26974332 (View on PubMed)

Related Links

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Other Identifiers

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PROactive WP4

Identifier Type: -

Identifier Source: org_study_id

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