Ignite Creation Date:
2025-12-25 @ 3:21 AM
Ignite Modification Date:
2026-01-22 @ 1:47 PM
Study NCT ID:
NCT03993405
Status:
COMPLETED
Last Update Posted:
2019-08-13
First Post:
2019-06-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cut-off Values of Muscle Thickness Ratio for Sarcopenia
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': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'SCREENING', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 292}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-06', 'completionDateStruct': {'date': '2019-08-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-08-10', 'studyFirstSubmitDate': '2019-06-18', 'studyFirstSubmitQcDate': '2019-06-19', 'lastUpdatePostDateStruct': {'date': '2019-08-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-06-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-07-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Muscle thickness', 'timeFrame': '30 minutes', 'description': 'Muscle thickness in millimeters by Ultrasound.'}, {'measure': 'Skeletal muscle mass', 'timeFrame': '2 minutes', 'description': 'Skeletal muscle mass will be evaluated by bioelectrical impedance analysis.The unit of measure is kg.'}], 'secondaryOutcomes': [{'measure': 'Muscle strength', 'timeFrame': '15 minutes', 'description': 'Muscle strength will be evaluated using an isokinetic dynamometer (Biodex Medical Systems, New York, USA). Knee and ankle muscle strength( flexion, extension, dorsiflexion and plantarflexion) will be evaluated. The unit of measure is Nm/kg.'}, {'measure': 'Peripheral strength', 'timeFrame': '1 minutes', 'description': 'The peripheral (handgrip) strength will be measured with a dynamometer (JAMAR).Three measurements will be taken, whose average of the three measurements will be collected. The unit of measure is kg.'}, {'measure': 'Physical function', 'timeFrame': '5 minutes', 'description': 'Physical function will be evaluated by short physical performance scale. The score of this scale range from 0 (worst performance) to 12 (best performance).'}, {'measure': 'Anthropometric assessments', 'timeFrame': '5 minutes', 'description': 'Participants waist, hip and calf circumferences will be measured by tape measure. The unit of measure is centimeters.'}, {'measure': 'Balance', 'timeFrame': '1 minute', 'description': 'Timed up and go test evaluates dynamic balance of participants. The timed up and go test measures the time that a patient needs to stand up from a chair, walk a 3-m distance, come back and sit back on the chair.Timed up and go test measure is second. The lower values indicates the better balance.'}, {'measure': 'Body mass index', 'timeFrame': '1 minute', 'description': "Participants' weight and height will be evaluated by electronic weighing and tape measure, respectively. body mass index will be expressed in in kg/ m²"}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['older people', 'muscle', 'ultrasound'], 'conditions': ['Sarcopenia']}, 'descriptionModule': {'briefSummary': 'The loss of muscle mass is one of the major diagnostic criteria for sarcopenia. Many methods are also used for the definition of sarcopenia. However there is no information about cut-off values in this respect in the literature. Therefore, the aim of this study is to determine the cut-off values of this ratio for confirming the diagnosis of sarcopenia.', 'detailedDescription': 'Decreases in total skeletal muscle mass are accepted to be necessary for confirming the diagnosis of sarcopenia. Many methods are also used for the definition of sarcopenia.\n\nHowever, ultrasound measurements has a high sensitivity and specify for confirming the diagnosis of sarcopenia. However there is no information about cut-off values in this respect in the literature. Therefore, the aim of this study is to determine the cut-off values of this ratio for confirming the diagnosis of sarcopenia.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* To be a volunteer to participate\n* To be an aged 18-90 years old.\n\nExclusion Criteria:\n\n* Walking with assist device\n* Having a visual deficits\n* Having an undergone orthopedic surgery\n* Having a cardiac pacemaker\n* Having a hypothyroidism, diabetes mellitus, renal/hepatic failure'}, 'identificationModule': {'nctId': 'NCT03993405', 'briefTitle': 'Cut-off Values of Muscle Thickness Ratio for Sarcopenia', 'organization': {'class': 'OTHER', 'fullName': 'Hacettepe University'}, 'officialTitle': 'Cut-off Values and Adjustments for Diagnosing Sarcopenia', 'orgStudyIdInfo': {'id': 'GO 18/506-39'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Control group:young', 'description': 'Sixty older subjects will be evaluated in this study.', 'interventionNames': ['Other: Ultrasonographic evaluation']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control Group:Middle-aged', 'description': 'Sixty middle-aged subjects will be evaluated in this study.', 'interventionNames': ['Other: Ultrasonographic evaluation']}, {'type': 'EXPERIMENTAL', 'label': 'Experimental group:older', 'description': 'Sixty older subjects will be evaluated in this study.', 'interventionNames': ['Other: Ultrasonographic evaluation']}], 'interventions': [{'name': 'Ultrasonographic evaluation', 'type': 'OTHER', 'description': 'Ultrasonographic measurement is assessment method to diagnosis of sarcopenia', 'armGroupLabels': ['Control Group:Middle-aged', 'Control group:young', 'Experimental group:older']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06100', 'city': 'Ankara', 'country': 'Turkey (Türkiye)', 'facility': 'Ozden Ozkal', 'geoPoint': {'lat': 39.91987, 'lon': 32.85427}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hacettepe University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Ozden Ozkal', 'investigatorAffiliation': 'Hacettepe University'}}}}