Ignite Creation Date:
2025-12-24 @ 3:52 PM
Ignite Modification Date:
2026-01-24 @ 7:43 PM
Study NCT ID:
NCT02140892
Status:
UNKNOWN
Last Update Posted:
2014-05-16
First Post:
2014-05-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Comparison Study of Two Respiratory Physical Therapy Methods and Standard Medical Treatment for Treating COPD Patients During Acute Exacerbation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D029424', 'term': 'Pulmonary Disease, Chronic Obstructive'}, {'id': 'D029481', 'term': 'Bronchitis, Chronic'}], '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': 'D001991', 'term': 'Bronchitis'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D001982', 'term': 'Bronchial Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 75}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2014-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-05', 'completionDateStruct': {'date': '2015-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2014-05-15', 'studyFirstSubmitDate': '2014-05-14', 'studyFirstSubmitQcDate': '2014-05-15', 'lastUpdatePostDateStruct': {'date': '2014-05-16', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-05-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'length of stay in the hospital', 'timeFrame': 'up to three months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Chronic Obstructive Pulmonary Disease', 'Chronic Bronchitis']}, 'descriptionModule': {'briefSummary': "One of the main goals of the respiratory physical therapy is to help people who are suffering from accumulating of secretions in their airways and lungs.\n\nChronic Obstructive Pulmonary Disease (COPD) patients are often hospitalized with an Acute Exacerbation of their medical condition.\n\nThose patients usually get only the standard medical care during the acute phase and don't get respiratory physical therapy treatment.\n\nThe study's main aim is to investigate if respiratory physical therapy treatment in addition to standard medical care during the acute phase, can improve the respiratory and medical condition and reduce hospitalization stay.\n\nIn order to do so we will compare three groups of COPD patients during acute exacerbation; two groups will get one out of two respiratory physical therapy techniques; manually or Intrapulmonary Percussive Ventilator (IPV) in addition to standard medical care and the third group will get standard medical care alone."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* clinical diagnosis of Acute Exacerbation of COPD or Acute Exacerbation of Chronic Bronchitis\n* Respiratory Rate\\>25\n* PaCO2\\> 45 mmHg\n* 7.35 \\< PH \\< 7.38\n\nExclusion Criteria:\n\n* intubation\n* apnea\n* glasgow coma scale \\< 8\n* pneumothorax\n* FEV1 \\< 50% predicted\n* Ischemic Hearth Disease'}, 'identificationModule': {'nctId': 'NCT02140892', 'briefTitle': 'A Comparison Study of Two Respiratory Physical Therapy Methods and Standard Medical Treatment for Treating COPD Patients During Acute Exacerbation', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Sheba Medical Center'}, 'orgStudyIdInfo': {'id': 'SHEBA-13-0697-YO-CTIL'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'respiratory physical therapy manual technique', 'description': 'respiratory physical therapy manual technique- Autogenic Drainage', 'interventionNames': ['Procedure: respiratory physical therapy manual technique- Autogenic Drainage']}, {'type': 'EXPERIMENTAL', 'label': 'respiratory physical therapy technique- IPV', 'description': 'respiratory physical therapy technique- Intrapulmonary Percussive Ventilation', 'interventionNames': ['Device: respiratory physical therapy technique- IPV']}, {'type': 'NO_INTERVENTION', 'label': 'standart medical care', 'description': 'standard medical care'}], 'interventions': [{'name': 'respiratory physical therapy manual technique- Autogenic Drainage', 'type': 'PROCEDURE', 'armGroupLabels': ['respiratory physical therapy manual technique']}, {'name': 'respiratory physical therapy technique- IPV', 'type': 'DEVICE', 'armGroupLabels': ['respiratory physical therapy technique- IPV']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Yaakov (kobi) Dagan, Msc.', 'role': 'CONTACT', 'email': 'kobi.dagan@sheba.health.gov.il', 'phone': '0523694979'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sheba Medical Center', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'SPONSOR'}}}}