Ignite Creation Date:
2026-03-26 @ 3:14 PM
Ignite Modification Date:
2026-03-30 @ 4:18 AM
Study NCT ID:
NCT07454759
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-03-06
First Post:
2026-02-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Acute Sarcopenia in Hospitalized Older Adults
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, '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': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 280}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-06-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2027-05-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-03-04', 'studyFirstSubmitDate': '2026-02-25', 'studyFirstSubmitQcDate': '2026-03-04', 'lastUpdatePostDateStruct': {'date': '2026-03-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-05-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'ACUTE SARCOPENIA INCIDENCE', 'timeFrame': 'Time point(s): baseline (within 24h of admission), days 3, 5, 7, 10, then every 5 days until hospital discharge (on average maximum 20 days after hospital admission).', 'description': 'Primary Objective: to determine the incidence of acute sarcopenia, defined as a reduction in muscle mass and strength during hospitalization in older adults.\n\nPrimary Endpoint: incidence of acute sarcopenia, defined as a reduction in muscle mass (BIA and anterior thigh ultrasound) and muscle strength (handgrip dynamometry) compared with baseline.'}], 'secondaryOutcomes': [{'measure': 'ACUTE SARCOPENIA RISK FACTORS AND OUTCOMES', 'timeFrame': 'Time point(s): baseline (within 24h of admission), days 3, 5, 7, 10, every 5 days until hospital discharge (on average maximum 20 days after hospital admission), and follow-ups at 3 and 6 months.', 'description': 'to identify clinical and demographic risk factors for acute sarcopenia, relevant clinical outcomes such as length of stay, nosocomial infections, pressure injuries, rehospitalization and mortality.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['sarcopenia', 'acute sarcopenia'], 'conditions': ['Sarcopenia', 'Sarcopenia in Elderly']}, 'descriptionModule': {'briefSummary': 'Acute sarcopenia is a rapid decline in muscle mass and function occurring within 28 days of a major stressor, such as hospitalization, infection, or surgery. It is frequent but often underdiagnosed in older adult. Current standard of care lacks systematic strategies for its early detection and risk stratification. This study therefore proposes to combine established clinical and instrumental assessments (handgrip dynamometry, bioelectrical impedance analysis, ultrasound of the anterior thigh) to better characterize the risk factors, and outcomes of acute sarcopenia in hospitalized patients aged 65 years or older.\n\nThe study hypothesis is that the use of a systematic objective clinical assessments will improve early detection and risk stratification of this condition and the detection of acute sarcopenia related outcomes.\n\nThis is a prospective observational cohort study that will be conducted in the Emergency Department and Medical Wards of the San Raffaele Hospital.\n\nStudies objectives will include:\n\n* Determination of the incidence of acute sarcopenia\n* Identification of clinical and demographic risk factors for acute sarcopenia and relevant clinical outcomes associated with this condition'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '65 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'hospitalized older people', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients aged 65 years or older.\n* Hospital admission for an acute medical condition\n\nExclusion Criteria:\n\n* Presence of pre-existing neuromuscular disorders.\n* Diagnosis of terminal illness with life expectancy less than 30 days\n* Refuse to sign written informed consent'}, 'identificationModule': {'nctId': 'NCT07454759', 'acronym': 'BASIS', 'briefTitle': 'Acute Sarcopenia in Hospitalized Older Adults', 'organization': {'class': 'OTHER', 'fullName': 'IRCCS San Raffaele'}, 'officialTitle': 'Towards Better Detection of Acute Sarcopenia in Hospitalized Older Adults: Integrating Clinical and Ultrasound Approaches', 'orgStudyIdInfo': {'id': 'BASIS'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Groups: older adults aged 65 years or above, hospitalized for acute medical condition', 'description': 'Groups: older adults (male and female) aged 65 years or above, hospitalized for acute medical conditions.', 'interventionNames': ['Diagnostic Test: Acute sarcopenia will be defined as the incidence of sarcopenia compared to baseline measurements at recruitment, using the European Working Group on Sarcopenia in older people 2 (EWGSOP2) criteria']}], 'interventions': [{'name': 'Acute sarcopenia will be defined as the incidence of sarcopenia compared to baseline measurements at recruitment, using the European Working Group on Sarcopenia in older people 2 (EWGSOP2) criteria', 'type': 'DIAGNOSTIC_TEST', 'description': 'The study procedures include:\n\n* Handgrip dynamometry to evaluate muscle strength using a standardized dynamometer.\n* Bioelectrical impedance analysis (BIA) and ultrasound of the anterior thigh to measure muscle mass.\n\nNo comparator procedure is foreseen. The regimen includes baseline assessment within 24 hours of admission, repeated evaluations on days 3, 5, 7, 10, and every five days until discharge (on average maximum 20 days after hospital admission), with follow-up visits at 3 and 6 months post-discharge.', 'armGroupLabels': ['Groups: older adults aged 65 years or above, hospitalized for acute medical condition']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Sarah Damanti, MD, PhD', 'role': 'CONTACT', 'email': 'damanti.sarah@hsr.it', 'phone': '+390226436095'}, {'name': 'Anna Fumagalli, MSc', 'role': 'CONTACT', 'email': 'fumagalli.anna@hsr.it', 'phone': '+390226436095'}], 'overallOfficials': [{'name': 'Sarah Damanti, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'IRCCS Ospedale San Raffaele'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'IRCCS San Raffaele', 'class': 'OTHER'}, 'collaborators': [{'name': 'Società Italiana di Medicina Interna', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Sarah Damanti', 'investigatorAffiliation': 'IRCCS San Raffaele'}}}}