Ignite Creation Date:
2025-12-25 @ 4:42 AM
Ignite Modification Date:
2026-02-28 @ 9:25 PM
Study NCT ID:
NCT01388218
Status:
COMPLETED
Last Update Posted:
2018-04-27
First Post:
2011-07-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Non-interventional Cross-over Study to Reduce Items of PROactive Tools Measuring Physical Activity in Chronic Obstructive Pulmonary Disease (COPD)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D029424', 'term': 'Pulmonary Disease, Chronic Obstructive'}, {'id': 'D009043', 'term': 'Motor Activity'}], 'ancestors': [{'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 236}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-07', 'completionDateStruct': {'date': '2012-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-04-26', 'studyFirstSubmitDate': '2011-07-04', 'studyFirstSubmitQcDate': '2011-07-04', 'lastUpdatePostDateStruct': {'date': '2018-04-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2011-07-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-12', 'type': 'ACTUAL'}}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Physical Activity', 'Patient Reported Outcome (PRO)', 'Chronic obstructive pulmonary disease (COPD)', 'Innovative Medicines Initiative - Joint Undertaking (IMI-JU)'], 'conditions': ['Chronic Obstructive Pulmonary Disease (COPD)']}, 'referencesModule': {'references': [{'pmid': '26022965', 'type': 'RESULT', 'citation': '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': '26974332', 'type': 'DERIVED', 'citation': '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.'}], 'seeAlsoLinks': [{'url': 'http://www.proactivecopd.com', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '40 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Stable COPD patients from Outpatients clinics and Primary care clinic\n\nExacerbated COPD patients from Inpatients', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 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.\n* Current or ex-smokers with a smoking history equivalent to at least 10 pack years.\n* Able to read and write and to use electronic devices and physical activity monitor.\n\nExclusion Criteria:\n\n* Orthopaedic, neurological or other complaints that significantly impair normal biomechanical movement patterns, as judged by the investigator.\n* Respiratory diseases other than COPD (e.g. asthma).\n* Cognitive impairment, as judged by the investigator'}, 'identificationModule': {'nctId': 'NCT01388218', 'briefTitle': 'Non-interventional Cross-over Study to Reduce Items of PROactive Tools Measuring Physical Activity in Chronic Obstructive Pulmonary Disease (COPD)', 'organization': {'class': 'OTHER', 'fullName': 'Barcelona Institute for Global Health'}, 'officialTitle': '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)', 'orgStudyIdInfo': {'id': 'PROactive WP4'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Arm 1 - Daily+Clinical', 'description': 'Order of assessment: Daily PRO + Clinical visit PRO'}, {'label': 'Arm 2 - Clinical+Daily', 'description': 'Order of assessment: Clinical visit PRO + Daily PRO'}]}, 'contactsLocationsModule': {'locations': [{'zip': '3000', 'city': 'Leuven', 'country': 'Belgium', 'facility': 'University Hospital Gasthuisberg, Katholieke Universiteit Leuven', 'geoPoint': {'lat': 50.87959, 'lon': 4.70093}}, {'city': 'Athens', 'country': 'Greece', 'facility': 'Thorax Research Foundation', 'geoPoint': {'lat': 37.98376, 'lon': 23.72784}}, {'city': 'Groningen', 'country': 'Netherlands', 'facility': 'University Medical Center', 'geoPoint': {'lat': 53.21917, 'lon': 6.56667}}, {'zip': 'SW3 6NP', 'city': 'London', 'state': 'England', 'country': 'United Kingdom', 'facility': 'Royal Brompton Hospital, Imperial College', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'zip': 'EH16 4TJ', 'city': 'Edinburgh', 'state': 'Scotland', 'country': 'United Kingdom', 'facility': "ELEGI/Colt laboratory UoE/MRC Centre for Inflammation Research The Queen's Medical Research Institute, University of Edinburgh", 'geoPoint': {'lat': 55.95206, 'lon': -3.19648}}], 'overallOfficials': [{'name': 'Judith Garcia-Aymerich, MD, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Barcelona Institute for Global Health'}, {'name': 'Niklas Karlsson', 'role': 'STUDY_CHAIR', 'affiliation': 'AstraZeneca'}, {'name': 'Thierry Troosters', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'KUL Leuven'}, {'name': 'Thys van der Molen', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Medical Center Groningen'}, {'name': 'Nick Hopkinson, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Imperial College London'}, {'name': 'Roberto Rabinovich, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Edinburgh'}, {'name': 'Ioannis Vogiatzis, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Thorax Research Foundation Athens'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Barcelona Institute for Global Health', 'class': 'OTHER'}, 'collaborators': [{'name': 'KU Leuven', 'class': 'OTHER'}, {'name': 'University of Edinburgh', 'class': 'OTHER'}, {'name': 'Royal Brompton & Harefield NHS Foundation Trust', 'class': 'OTHER'}, {'name': 'University Medical Center Groningen', 'class': 'OTHER'}, {'name': 'University of Athens', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}