Ignite Creation Date:
2025-12-24 @ 6:41 PM
Ignite Modification Date:
2025-12-29 @ 11:43 PM
Study NCT ID:
NCT01483157
Status:
UNKNOWN
Last Update Posted:
2014-02-28
First Post:
2011-11-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Vascular Occlusion and Rheumatoid Arthritis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001172', 'term': 'Arthritis, Rheumatoid'}], 'ancestors': [{'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}, {'id': 'D003240', 'term': 'Connective Tissue Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2011-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-02', 'completionDateStruct': {'date': '2015-11', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2014-02-27', 'studyFirstSubmitDate': '2011-11-29', 'studyFirstSubmitQcDate': '2011-11-30', 'lastUpdatePostDateStruct': {'date': '2014-02-28', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-12-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'muscle strength', 'timeFrame': 'twelve weeks'}], 'secondaryOutcomes': [{'measure': 'quality of life', 'timeFrame': 'twelve weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Rheumatoid Arthritis']}, 'referencesModule': {'references': [{'pmid': '31033228', 'type': 'DERIVED', 'citation': 'Rodrigues R, Ferraz RB, Kurimori CO, Guedes LK, Lima FR, de Sa-Pinto AL, Gualano B, Roschel H. Low-Load Resistance Training With Blood-Flow Restriction in Relation to Muscle Function, Mass, and Functionality in Women With Rheumatoid Arthritis. Arthritis Care Res (Hoboken). 2020 Jun;72(6):787-797. doi: 10.1002/acr.23911. Epub 2020 May 14.'}]}, 'descriptionModule': {'briefSummary': 'Resistance exercise plus vascular occlusion may induce greater improvements in strength and muscle mass resistance training alone. The investigators speculate this training strategy could be beneficial in patients with rheumatoid arthritis.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '30 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* female with rheumatoid arthritis\n* Disease activity scores \\> 2.6\n* use of anti-TNF-alpha drugs for at least 8 weeks\n\nExclusion Criteria:\n\n* BMD \\< 20 kg/m2\n* fibromyalgia\n* cardiovascular disease'}, 'identificationModule': {'nctId': 'NCT01483157', 'briefTitle': 'Vascular Occlusion and Rheumatoid Arthritis', 'organization': {'class': 'OTHER', 'fullName': 'University of Sao Paulo'}, 'officialTitle': 'Effects of Strength Training With Vascular Occlusion in Patients With Rheumatoid Arthritis: A Randomized Clinical Trial', 'orgStudyIdInfo': {'id': 'vascular occlusion and RA'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'low intensity with vascular occlusion', 'interventionNames': ['Other: vascular occlusion with exercise trainig']}, {'type': 'EXPERIMENTAL', 'label': 'high intensity resistance training', 'interventionNames': ['Other: high intensity resistance training']}, {'type': 'NO_INTERVENTION', 'label': 'no exercise training'}], 'interventions': [{'name': 'vascular occlusion with exercise trainig', 'type': 'OTHER', 'description': 'twelve weeks of resistance training with vascular occlusion twice a week', 'armGroupLabels': ['low intensity with vascular occlusion']}, {'name': 'high intensity resistance training', 'type': 'OTHER', 'description': 'twelve weeks of resistance training twice a week', 'armGroupLabels': ['high intensity resistance training']}]}, 'contactsLocationsModule': {'locations': [{'zip': '05403-010', 'city': 'São Paulo', 'state': 'São Paulo', 'status': 'RECRUITING', 'country': 'Brazil', 'contacts': [{'name': 'Reynaldo Costa Rodrigues, PhD Student', 'role': 'CONTACT', 'email': 'rcrodriguespt@yahoo.com.br', 'phone': '55 11 26618022'}, {'name': 'Ana Lucia Sa Pinto, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Lissiane Noronha Guedes, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Bruno Gualano, PhD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'University of Sao Paulo - School of Medicine - Clinical Hospital', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Sao Paulo', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Bruno Gualano', 'investigatorAffiliation': 'University of Sao Paulo'}}}}