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

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ClinicalTrials.gov Identifier: NCT01388218
Recruitment Status : Completed
First Posted : July 6, 2011
Last Update Posted : April 27, 2018
Sponsor:
Collaborators:
KU Leuven
University of Edinburgh
Royal Brompton & Harefield NHS Foundation Trust
University Medical Center Groningen
University of Athens
Information provided by (Responsible Party):
Barcelona Institute for Global Health

Study Description
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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.

Condition or disease
Chronic Obstructive Pulmonary Disease (COPD)

Study Design
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Study Type : Observational
Actual Enrollment : 236 participants
Observational Model: Case-Crossover
Time Perspective: Cross-Sectional
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 Start Date : July 2011
Actual Primary Completion Date : December 2011
Actual Study Completion Date : December 2012

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort
Arm 1 - Daily+Clinical
Order of assessment: Daily PRO + Clinical visit PRO
Arm 2 - Clinical+Daily
Order of assessment: Clinical visit PRO + Daily PRO


Outcome Measures
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Eligibility Criteria
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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   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

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01388218


Locations
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Belgium
University Hospital Gasthuisberg, Katholieke Universiteit Leuven
Leuven, Belgium, 3000
Greece
Thorax Research Foundation
Athens, Greece
Netherlands
University Medical Center
Groningen, Netherlands
United Kingdom
Royal Brompton Hospital, Imperial College
London, England, United Kingdom, SW3 6NP
ELEGI/Colt laboratory UoE/MRC Centre for Inflammation Research The Queen's Medical Research Institute, University of Edinburgh
Edinburgh, Scotland, United Kingdom, EH16 4TJ
Sponsors and Collaborators
Barcelona Institute for Global Health
KU Leuven
University of Edinburgh
Royal Brompton & Harefield NHS Foundation Trust
University Medical Center Groningen
University of Athens
Investigators
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Study Chair: Judith Garcia-Aymerich, MD, PhD Barcelona Institute for Global Health
Study Chair: Niklas Karlsson AstraZeneca
Principal Investigator: 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
More Information
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Additional Information:

Publications of Results:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Barcelona Institute for Global Health
ClinicalTrials.gov Identifier: NCT01388218    
Other Study ID Numbers: PROactive WP4
First Posted: July 6, 2011    Key Record Dates
Last Update Posted: April 27, 2018
Last Verified: July 2015
Keywords provided by Barcelona Institute for Global Health:
Physical Activity
Patient Reported Outcome (PRO)
Chronic obstructive pulmonary disease (COPD)
Innovative Medicines Initiative - Joint Undertaking (IMI-JU)
Additional relevant MeSH terms:
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Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases