Ignite Creation Date:
2025-12-25 @ 3:20 AM
Ignite Modification Date:
2025-12-26 @ 1:58 AM
Study NCT ID:
NCT04451005
Status:
COMPLETED
Last Update Posted:
2020-06-30
First Post:
2020-06-02
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Diagnostic Evaluation of Sarcopenia in Elderly Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D055948', 'term': 'Sarcopenia'}], 'ancestors': [{'id': 'D009133', 'term': 'Muscular Atrophy'}, {'id': 'D020879', 'term': 'Neuromuscular Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D001284', 'term': 'Atrophy'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 403}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-05-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-06', 'completionDateStruct': {'date': '2019-12-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-06-25', 'studyFirstSubmitDate': '2020-06-02', 'studyFirstSubmitQcDate': '2020-06-25', 'lastUpdatePostDateStruct': {'date': '2020-06-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-06-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-05-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Sarcopenia in the elderly', 'timeFrame': '12 months', 'description': 'Evaluation of sarcopenia in the elderly'}], 'secondaryOutcomes': [{'measure': 'Development of a new tool for sarcopenia screening', 'timeFrame': '12 months', 'description': 'Development of a new tool for sarcopenia screening'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Body composition', 'Sarcopenia', 'Elderly'], 'conditions': ['Sarcopenia']}, 'descriptionModule': {'briefSummary': 'Sarcopenia is a generalized progressive skeletal muscle disorder that represents a related physiological vulnerability that is associated with or increases the likelihood of adverse outcomes, including falls, fractures, physical disability and death. The parameters used to assess sarcopenia in clinical practice have limited use due to their custody.\n\nIn this perspective, this study proposes or develops a tool for the diagnosis of having sarcopenia with a specific boa and a sensitive boa.\n\nlow cost and useful.\n\nElderly patients (n = 403) from the Geriatrics Outpatient Clinic of Hospital das Clínicas, Faculty of Medicine, University of São Paulo will be selected\n\nThis study was of clinical importance, due to sarcopenia and a relevant factor, and could lead to consequences and poor prognosis in patients with gold, and it was not a method of clinical practice to properly endorse body composition in this population.', 'detailedDescription': 'Sarcopenia is a progressive and generalized skeletal muscle disorder that represents an age-related physiological vulnerability that is associated with an increased likelihood of adverse outcomes, including falls, fractures, physical disability and mortality. The parameters used to assess sarcopenia in clinical practice have limited use due to its cost.\n\nIn this perspective, this study proposes the development of a tool for the diagnosis of having sarcopenia with good specificity and good sensitivity and of low cost and useful.\n\nElderly patients (n = 403) from the Geriatrics Outpatient Clinic of Hospital das Clínicas, Faculty of Medicine, University of São Paulo will be selected. After signing the informed consent, sarcopenia will be assessed using the reference method (DXA) and anthropometry. The data obtained by the methods are treated statistically to obtain correlation and thus a new tool for the evaluation of sarcopenia patients in the elderly can be developed.\n\nThis study is of clinical importance, as sarcopenia is a relevant factor and can lead to consequences and poor prognosis in elderly patients, and there is no low-cost method in clinical practice to properly assess body composition in this population.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '60 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Elderly patients over 60 years old, with cognitive ability and interested in participating in the study', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥ 60 years\n* Sign free and informed consent;\n* Demonstrate interest, conditions and availability to participate in all procedures included in the study protocol;\n\nExclusion Criteria:\n\n* Refusal to participate;\n* Patients who have not undergone cognitive testing;\n* Physical amputation;\n* Patients undergoing interventional treatment for sarcopenia;'}, 'identificationModule': {'nctId': 'NCT04451005', 'briefTitle': 'Diagnostic Evaluation of Sarcopenia in Elderly Patients', 'organization': {'class': 'OTHER', 'fullName': 'University of Sao Paulo'}, 'officialTitle': 'Development of a New Sarcopenia Screening Tool in the Elderly', 'orgStudyIdInfo': {'id': 'SARC-F'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Elderly patients with sarcopenia', 'description': 'Elderly patients with sarcopenia', 'interventionNames': ['Other: 0']}], 'interventions': [{'name': '0', 'type': 'OTHER', 'description': 'Elderly patients with sarcopenia', 'armGroupLabels': ['Elderly patients with sarcopenia']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Sao Paulo', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal researcher', 'investigatorFullName': 'Dan Linetzky Waitzberg', 'investigatorAffiliation': 'University of Sao Paulo'}}}}