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

This study has been completed.
Sponsor:
Collaborators:
Katholieke Universiteit Leuven
University of Edinburgh
Royal Brompton & Harefield NHS Foundation Trust
University Medical Centre Groningen
University of Athens
Information provided by (Responsible Party):
Centre for Research in Environmental Epidemiology, Spain
ClinicalTrials.gov Identifier:
NCT01388218
First received: July 4, 2011
Last updated: March 29, 2013
Last verified: March 2013
  Purpose

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
Chronic Obstructive Pulmonary Disease (COPD)

Study Type: Observational
Study Design: 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)

Resource links provided by NLM:


Further study details as provided by Centre for Research in Environmental Epidemiology, Spain:

Enrollment: 236
Study Start Date: July 2011
Study Completion Date: December 2012
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
Arm 1
Order of assessment: Daily PRO + Clinical visit PRO
Arm 2
Order of assessment: Clinical visit PRO + Daily PRO

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01388218

Locations
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
Centre for Research in Environmental Epidemiology, Spain
Katholieke Universiteit Leuven
University of Edinburgh
Royal Brompton & Harefield NHS Foundation Trust
University Medical Centre Groningen
University of Athens
Investigators
Study Chair: Judith Garcia-Aymerich, MD, PhD Centre for Research in Environmental Epidemiology, Spain
Study Chair: Niklas Karlsson AstraZeneca
Principal Investigator: Thierry Troosters KUL Leuven
Principal Investigator: Thys van der Molen University Medical Centre 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

Additional Information:
No publications provided

Responsible Party: Centre for Research in Environmental Epidemiology, Spain
ClinicalTrials.gov Identifier: NCT01388218     History of Changes
Other Study ID Numbers: PROactive WP4
Study First Received: July 4, 2011
Last Updated: March 29, 2013
Health Authority: Belgium: Ethics Committee
Greece: Ethics Committee
Netherlands: Independent Ethics Committee
United Kingdom: Research Ethics Committee
PROactive Ethics Board (Chair: Dr Pim de Boer, pim.de.boer@astmafonds.nl)

Keywords provided by Centre for Research in Environmental Epidemiology, Spain:
Physical Activity
Patient Reported Outcome (PRO)
Chronic obstructive pulmonary disease (COPD)
Innovative Medicines Initiative - Joint Undertaking (IMI-JU)

Additional relevant MeSH terms:
Lung Diseases
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on August 18, 2014