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:
Centre for Research in Environmental Epidemiology, Spain
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
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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
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 Respiration Disorders Pulmonary Disease, Chronic Obstructive Lung Diseases, Obstructive Respiratory Tract Diseases |
ClinicalTrials.gov processed this record on May 21, 2013