Ignite Creation Date:
2025-12-24 @ 3:20 PM
Ignite Modification Date:
2025-12-25 @ 8:31 PM
Study NCT ID:
NCT00628992
Status:
TERMINATED
Last Update Posted:
2015-03-27
First Post:
2008-02-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Early Rehabilitation of COPD Patients in ICU
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': 5}}, 'statusModule': {'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2008-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-03', 'completionDateStruct': {'date': '2011-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-03-26', 'studyFirstSubmitDate': '2008-02-04', 'studyFirstSubmitQcDate': '2008-02-25', 'lastUpdatePostDateStruct': {'date': '2015-03-27', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-03-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number day breathing without assistance during the 28-day study period', 'timeFrame': 'during the 28-day study period'}], 'secondaryOutcomes': [{'measure': 'Mortality at day 28 and day 90', 'timeFrame': 'Measured within the ICU stay of the patient'}, {'measure': 'Length of stay in intensive care unit and hospital', 'timeFrame': 'Measured within the ICU stay of the patient'}, {'measure': 'Clinical measurement of muscular strength in lower limbs(day 0-2 and day 28-30)', 'timeFrame': 'Measured within the ICU stay of the patient'}]}, 'conditionsModule': {'keywords': ['COPD: chronic obstructive pulmonary disease and acute respiratory failure'], 'conditions': ['Chronic Obstructive Pulmonary Disease', 'Acute Respiratory Failure']}, 'descriptionModule': {'briefSummary': 'Twenty per cent of the intensive care patients mechanically ventilated suffer from chronic obstructive pulmonary disease (COPD). These patients stay longer in Intensive Care which is more costly and they are more prone to nosocomial infection.In addition, they are longer bedridden and they develop muscular weakness.Prolonged inactivity results in respiratory and skeletal muscle weakness which curtails simple daily activity.The principal purpose of this study is to compare two types of muscular rehabilitation (electrical stimulation of the thigh and/or cycloergometer training) to classic passive mobilization of the leg.The second purpose is to analyse the effects of each type of rehabilitation on muscular fiber (structural and functional analysis) by muscular biopsies.Two hundred forty COPD patients admitted in the intensive care unit for acute respiratory failure will be randomized in 4: 1 fashion to receive passive mobilization of the legs(group 1, n=60), electrical stimulation of the thigh (group 2, n=60), cycloergometer training (group 3, n=60) or electrical stimulation of the thigh and cycloergometer training(group 4, n=60).The rehabilitation program will last 4 weeks with 5 sessions per week.In each group of patients, muscular biopsies will be done under local anaesthesia at the beginning and end of the rehabilitation programme and when they are discharged from the service.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient older than 18 years of age\n* Chronic obstructive pulmonary disease\n* Intubated with mechanical ventilation\n* Patients without sedation or catecholamine\n* 2 previous spontaneous breathing trial at 24 hour intervals with T-piece having been unsuccessful\n* Conscious and cooperative state\n* Ability for the patient to sit in a armchair\n\nExclusion Criteria:\n\n* Non chronic obstructive pulmonary disease\n* Lack of patient involvement\n* Minor Patients\n* Patients under guardianship\n* Unconscious and non cooperative state\n* Patients unable to ride in a wheelchair\n* Patients not affiliated with a Social Security System\n* Patients under justice safeguard\n* Patients under curator ship'}, 'identificationModule': {'nctId': 'NCT00628992', 'briefTitle': 'Early Rehabilitation of COPD Patients in ICU', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Strasbourg, France'}, 'officialTitle': 'Effects of Early Rehabilitation in Chronic Obstructive Pulmonary Disease Patients Under Mechanical Ventilation for Acute Respiratory Failure in Intensive Care Unit.', 'orgStudyIdInfo': {'id': '3912'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': '1', 'interventionNames': ['Other: No specific intervention, standard therapy serving as a control group, passive mobilization of the legs']}, {'type': 'ACTIVE_COMPARATOR', 'label': '2', 'interventionNames': ['Other: Electrical stimulation of the thigh']}, {'type': 'ACTIVE_COMPARATOR', 'label': '3', 'interventionNames': ['Other: Cycloergometer training']}, {'type': 'ACTIVE_COMPARATOR', 'label': '4', 'interventionNames': ['Other: Electrical stimulation of the thigh and cycloergometer training']}], 'interventions': [{'name': 'No specific intervention, standard therapy serving as a control group, passive mobilization of the legs', 'type': 'OTHER', 'description': 'Muscular rehabilitation of the leg', 'armGroupLabels': ['1']}, {'name': 'Electrical stimulation of the thigh', 'type': 'OTHER', 'description': 'Muscular rehabilitation of the leg', 'armGroupLabels': ['2']}, {'name': 'Cycloergometer training', 'type': 'OTHER', 'description': 'Muscular rehabilitation of the leg', 'armGroupLabels': ['3']}, {'name': 'Electrical stimulation of the thigh and cycloergometer training', 'type': 'OTHER', 'description': 'Muscular rehabilitation of the leg', 'armGroupLabels': ['4']}]}, 'contactsLocationsModule': {'locations': [{'zip': '67091', 'city': 'Strasbourg', 'country': 'France', 'facility': 'Service de Réanimation Médicale, Hôpital Civil, Hôpitaux Universitaires de Strasbourg', 'geoPoint': {'lat': 48.58392, 'lon': 7.74553}}, {'zip': '67091', 'city': 'Strasbourg', 'country': 'France', 'facility': 'Service des Explorations Fonctionnelles Respiratoires, Hôpital Civil, Hôpitaux Universitaires de Strasbourg', 'geoPoint': {'lat': 48.58392, 'lon': 7.74553}}, {'zip': '67098', 'city': 'Strasbourg', 'country': 'France', 'facility': 'Service de Médecine Physique et de Réadaptation, Hôpital de Hautepierre, Hôpitaux Universitaires de Strasbourg', 'geoPoint': {'lat': 48.58392, 'lon': 7.74553}}, {'zip': '67098', 'city': 'Strasbourg', 'country': 'France', 'facility': 'Service de Réanimation Médicale, Hôpital de Hautepierre, Hôpitaux Universitaires de Strasbourg', 'geoPoint': {'lat': 48.58392, 'lon': 7.74553}}], 'overallOfficials': [{'name': 'Vincent CASTELAIN, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hôpitaux Universitaires de Strasbourg'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Strasbourg, France', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}