Ignite Creation Date:
2025-12-24 @ 5:39 PM
Ignite Modification Date:
2025-12-28 @ 6:12 AM
Study NCT ID:
NCT01305668
Status:
COMPLETED
Last Update Posted:
2014-12-10
First Post:
2011-02-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Rehabilitation in Chronic Obstructive Pulmonary Disease (COPD) Patients With Emphysema
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D029424', 'term': 'Pulmonary Disease, Chronic Obstructive'}, {'id': 'D004646', 'term': 'Emphysema'}], '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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-12', 'completionDateStruct': {'date': '2012-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-12-09', 'studyFirstSubmitDate': '2011-02-28', 'studyFirstSubmitQcDate': '2011-02-28', 'lastUpdatePostDateStruct': {'date': '2014-12-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-03-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Exercise tolerance', 'timeFrame': '[Time Frame: Day 1 and 20 ]', 'description': 'Change in Six minute walked distance (6MWD)'}], 'secondaryOutcomes': [{'measure': 'Dyspnoea', 'timeFrame': '[ Time Frame: Day 1 and 20]', 'description': 'Change in dyspnea grade by MRC'}, {'measure': 'Symptoms on effort', 'timeFrame': '[ Time Frame: Day 1 and 20]', 'description': 'Change in Dyspnoea and leg fatigue by Borg scale'}, {'measure': 'Perceived Quality of life', 'timeFrame': '[ Time Frame: Day 1 and 20]', 'description': 'Change in Saint George Respiratory Questionnarie (Italian version)'}, {'measure': 'Global function', 'timeFrame': '[ Time Frame: Day 1 and 20]', 'description': 'Change in the multidimensional BODE index (validated in COPD population)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['COPD', 'Emphysema phenotype'], 'conditions': ['Chronic Obstructive Pulmonary Disease', 'Emphysema']}, 'descriptionModule': {'briefSummary': 'Chronic Obstructive Pulmonary Disease has two heterogeneous conditions (chronic bronchitis and pulmonary emphysema phenotypes) with a different clinical presentation.\n\nThe phenotype evaluation in COPD patient (trough clinical, functional and radiographic parameters) could influence final results in pharmacologic and non-pharmacologic management of the disease.\n\nThe aim of our study is to investigate whether COPD patients with different disease phenotype (chronic bronchitis versus pulmonary emphysema) have a different response to PR.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '40 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'COPD patients with or without Emphysema phenotype', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* COPD disease with any functional grade\n* Adherence to participate to a pulmonary rehabilitation program\n\nExclusion Criteria:\n\n* Recent acute exacerbation (4 weeks preceding enrollment)\n* Acute severe concomitant cardiovascular diseases\n* Concomitant neoplastic diseases\n* NO-Adherence to participate to a pulmonary rehabilitation program'}, 'identificationModule': {'nctId': 'NCT01305668', 'briefTitle': 'Rehabilitation in Chronic Obstructive Pulmonary Disease (COPD) Patients With Emphysema', 'organization': {'class': 'OTHER', 'fullName': 'Villa Pineta Hospital'}, 'officialTitle': 'Effectiveness of Pulmonary Rehabilitation in Chronic Obstructive Pulmonary Disease (COPD) Patients With Emphysema Phenotype', 'orgStudyIdInfo': {'id': 'VP-01-2011'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Emphysema phenotype'}, {'label': 'No-Emphysema phenotype'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Lumezzane', 'state': 'Brescia', 'country': 'Italy', 'facility': 'Fondazione Maugeri IRCCS', 'geoPoint': {'lat': 45.64789, 'lon': 10.26487}}, {'zip': '41026', 'city': 'Pavullo nel Frignano', 'state': 'Modena', 'country': 'Italy', 'facility': 'Villa Pineta Hospital', 'geoPoint': {'lat': 44.33352, 'lon': 10.83544}}, {'city': 'Volterra', 'state': 'Pisa', 'country': 'Italy', 'facility': 'Auxilium Vitae Rehabilitation Center', 'geoPoint': {'lat': 43.40251, 'lon': 10.86152}}, {'city': 'Velletri', 'state': 'Roma', 'country': 'Italy', 'facility': 'Ospedale San Raffaele', 'geoPoint': {'lat': 41.68573, 'lon': 12.77753}}, {'city': 'Naples', 'country': 'Italy', 'facility': 'Clinic Center', 'geoPoint': {'lat': 40.85216, 'lon': 14.26811}}], 'overallOfficials': [{'name': 'Enrico M Clini, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Villa Pineta Hospital and University of Modena and Reggio Emilia'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Villa Pineta Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Villa Pineta Hospital', 'investigatorFullName': 'Prof. Clini Enrico', 'investigatorAffiliation': 'Villa Pineta Hospital'}}}}