Ignite Creation Date:
2025-12-24 @ 1:02 PM
Ignite Modification Date:
2026-05-30 @ 6:06 AM
Study NCT ID:
NCT02190461
Status:
COMPLETED
Last Update Posted:
2018-09-06
First Post:
2014-07-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Impact of Early Respiratory Rehabilitation in the Exacerbations of Re-admitted COPD Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D029424', 'term': 'Pulmonary Disease, Chronic Obstructive'}], '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': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 39}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-09', 'completionDateStruct': {'date': '2017-06-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-09-04', 'studyFirstSubmitDate': '2014-07-11', 'studyFirstSubmitQcDate': '2014-07-11', 'lastUpdatePostDateStruct': {'date': '2018-09-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-07-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-06-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Exacerbations', 'timeFrame': '1 year', 'description': 'Exacerbations with or without admission due to respiratory illness'}], 'secondaryOutcomes': [{'measure': 'Dyspnea', 'timeFrame': '1 year', 'description': 'dyspnea in activities of daily living measured by the area of the dyspnea in the original CRQ questionnaire'}, {'measure': 'Functional capacity', 'timeFrame': '1 year', 'description': 'Exercise capacity with the six minutes walk test'}, {'measure': 'Quality of life related to health', 'timeFrame': '1 year', 'description': 'Quality of life related to health from self-administered CAT and CRC questionnaires'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Early Respiratory Rehabilitation', 'Chronic Obstructive Pulmonary Disease', 'Re-admitted patients', 'Open clinical trial', 'Exacerbations'], 'conditions': ['Pulmonary Disease, Chronic Obstructive']}, 'referencesModule': {'references': [{'pmid': '33287581', 'type': 'DERIVED', 'citation': 'Guell-Rous MR, Morante-Velez F, Flotats-Farre G, Paz-Del Rio LD, Closa-Rusines C, Ouchi-Vernet D, Segura-Medina M, Bolibar-Ribas I. Timing of Pulmonary Rehabilitation in Readmitted Patients with Severe Chronic Obstructive Pulmonary Disease: A Randomized Clinical Trial. COPD. 2021 Feb;18(1):26-34. doi: 10.1080/15412555.2020.1856059. Epub 2020 Dec 7.'}]}, 'descriptionModule': {'briefSummary': 'Open clinical trial with 1 year follow up comparing the impact of an Early Respiratory Rehabilitation program with the conventional Respiratory Rehabilitation in COPD re-admitted patients. Outcomes will be exacerbations, symptoms, functional capacity and quality of life related to health (HRQOL).', 'detailedDescription': 'Open clinical trial with 1 year follow up comparing the impact of an Early Respiratory Rehabilitation (ERR) program with the conventional Respiratory Rehabilitation (CRR) in COPD re-admitted patients. Outcomes will be exacerbations, symptoms, functional capacity and quality of life related to health (HRQOL). Sixty patients will be randomized into the two groups: ERR starts the program during admission and continues at home immediately after discharge for a period of 3 months; CRR was started at home one month after discharge from hospital and continues for 3 months. Recruitment of patients and starting the RR program will occur in the first year. In the second year we will continue the intervention to those who have not completed the year. Follow-up will last until the completion of the year of all patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '110 Years', 'minimumAge': '41 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age\\> 40 years\n* Diagnostic criteria of COPD GOLD II-IV confirmed by spirometry\n* Having frequent re-admissions (≥ 2 times / year).\n* Sign the informed consent.\n\nExclusion Criteria:\n\n* Have completed a pulmonary rehabilitation program (including training) in the last 6 months.\n* Respiratory and / or cardiac serious associated diseases.\n* End-stage COPD (inability to perform exercises or treatment with morphine).\n* Prognosis of \\<6 months.\n* Living in a residence or not having a primary caregiver.\n* Cognitive disorders that prevent active participation.\n* Patients who are admired to other hospitalization rooms than Pneumology.\n* Patients who do not belong to the area of health coverage of the Respiratory Rehabilitation home team'}, 'identificationModule': {'nctId': 'NCT02190461', 'briefTitle': 'Impact of Early Respiratory Rehabilitation in the Exacerbations of Re-admitted COPD Patients', 'organization': {'class': 'OTHER', 'fullName': "Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau"}, 'officialTitle': 'Impact of Early Respiratory Rehabilitation in the Exacerbations of Re-admitted Patients With Chronic Obstructive Pulmonary Disease (COPD)', 'orgStudyIdInfo': {'id': 'IIBSP-EXA-2013-04'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Early Respiratory Rehabilitation', 'description': 'Starting the Early Respiratory Rehabilitation programme during the admission and continues it at home immediately after discharge for a period of 3 months.', 'interventionNames': ['Procedure: Early Respiratory Rehabilitation Program']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Conventional Respiratory Rehabilitation', 'description': 'Started a conventional Respiratory Rehabilitation programme at home one month after discharge from hospital and continues for 3 months.', 'interventionNames': ['Procedure: Conventional Respiratory Rehabilitation Program']}], 'interventions': [{'name': 'Early Respiratory Rehabilitation Program', 'type': 'PROCEDURE', 'armGroupLabels': ['Early Respiratory Rehabilitation']}, {'name': 'Conventional Respiratory Rehabilitation Program', 'type': 'PROCEDURE', 'armGroupLabels': ['Conventional Respiratory Rehabilitation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '08025', 'city': 'Barcelona', 'country': 'Spain', 'facility': 'Servicio de Neumología Hospital de la Santa Creu i Sant Pau', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}], 'overallOfficials': [{'name': 'Fátima E Morante, Nurse', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau", 'class': 'OTHER'}, 'collaborators': [{'name': 'Spanish Society of Pneumology and Thoracic Surgery', 'class': 'OTHER'}, {'name': 'Spanish Clinical Research Network - SCReN', 'class': 'NETWORK'}], 'responsibleParty': {'type': 'SPONSOR'}}}}