Ignite Creation Date:
2025-12-25 @ 12:04 AM
Ignite Modification Date:
2026-01-01 @ 4:09 PM
Study NCT ID:
NCT05113758
Status:
COMPLETED
Last Update Posted:
2023-08-30
First Post:
2021-10-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Sarcopenia Measured by Ultrasound in Hospitalized Older Adults
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': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 161}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-05-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-08', 'completionDateStruct': {'date': '2022-06-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-08-29', 'studyFirstSubmitDate': '2021-10-29', 'studyFirstSubmitQcDate': '2021-10-29', 'lastUpdatePostDateStruct': {'date': '2023-08-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-11-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-06-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Prevalence of sarcopenia on admission', 'timeFrame': '72 hours', 'description': 'Prevalence of sarcopenia on admission. A prevalent case of sarcopenia will be considered if a patient fulfills the EWGSOP2 at admission'}, {'measure': 'Incidence of sarcopenia between admission and discharge', 'timeFrame': '15 days', 'description': 'An incident case of sarcopenia will be considered if a patient not fulfilling EWGSOP2 diagnostic criteria on admission, will meet diagnostic criteria at discharge of sarcopenia at discharge (diagnosis will be considered as a dichotomous variable -yes/no-).'}, {'measure': 'Muscle mass (the anterior rectus femoris muscle)', 'timeFrame': '15 days', 'description': 'The evolution of muscle mass between admission and discharge will be assessed by ultrasound'}], 'secondaryOutcomes': [{'measure': 'Minimal nutritional assessment (MNA-SF) score', 'timeFrame': '72 hours', 'description': "The mini-nutritional assessment - short form is a simple, non - invasive and validated scale for the detection of malnutrition in older adults. It takes into account the patient's loss of appetite, weight loss, motor skills, recent health status, neuropsychological disorders. The maximum score of the MNA-SF is 14:\n\nGreater than or equal to 11: normal nutritional status. Between 8 and 11: risk of malnutrition. Less than 8: malnutrition."}, {'measure': 'Hand grip strength', 'timeFrame': '15 days', 'description': 'Using a hand-held dynamometer'}, {'measure': '4-meter walking speed test', 'timeFrame': '15 days', 'description': 'The evolution of the value of the 4-meter walking speed test between admission and discharge will be assessed.'}, {'measure': 'ADL (Activities of Daily Living) questionnaire', 'timeFrame': '3 months', 'description': 'the ADL questionnaire will also be performed on admission, at discharge, and at 3 months.'}, {'measure': 'SPPB score (SHORT PHYSICAL PERFORMANCE BATTERY score)', 'timeFrame': '15 days', 'description': 'Short Physical Performance Battery (SPPB): score range 0-12, higher score means a better outcome'}, {'measure': 'Mortality', 'timeFrame': '3 months', 'description': 'Mortality will be measured with vital status at 3 months.'}, {'measure': 'Length of stay, days', 'timeFrame': '15 days', 'description': 'Day of admission to day of discharge'}, {'measure': 'Readmission(s) after index hospitalization', 'timeFrame': '3 months', 'description': 'Readmission(s) after index hospitalization, Dichotomous outcome (yes/no)'}, {'measure': 'Emergency department (ED) visit(s)', 'timeFrame': '3 months', 'description': 'ED visit(s) after index hospitalization, Dichotomous outcome (yes/no)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['sarcopenia', 'ultrasound', 'aged', 'hospitalized'], 'conditions': ['Sarcopenia']}, 'referencesModule': {'references': [{'pmid': '38267149', 'type': 'DERIVED', 'citation': 'Lopez Jimenez E, Neira Alvarez M, Menendez Colino R, Checa Lopez M, Grau Jimenez C, Perez Rodriguez P, Vasquez Brolen B, Arias Munana E, Ramirez Martin R, Alonso Bouzon C, Amor Andres MS, Bermejo Boixareu C, Branas F, Alcantud Ibanez M, Alcantud Corcoles R, Cortes Zamora EB, Gomez Jimenez E, Romero Rizos L, Avendano Cespedes A, Hernandez Socorro CR, Abizanda P. Muscle mass loss measured with portable ultrasound in hospitalized older adults: The ECOSARC study. J Nutr Health Aging. 2024 Jan;28(1):100010. doi: 10.1016/j.jnha.2023.100010. Epub 2023 Dec 14.'}, {'pmid': '36949412', 'type': 'DERIVED', 'citation': 'Lopez Jimenez E, Neira Alvarez M, Ramirez Martin R, Alonso Bouzon C, Amor Andres MS, Bermejo Boixareu C, Branas F, Menendez Colino R, Arias Munana E, Checa Lopez M, Grau Jimenez C, Perez Rodriguez P, Alcantud Ibanez M, Vasquez Brolen B, Oliva J, Pena Longobardo LM, Alcantud Corcoles R, Cortes Zamora EB, Gomez Jimenez E, Romero Rizos L, Avendano Cespedes A, Hernandez Socorro CR, Abizanda P. "SARCOPENIA MEASURED BY ULTRASOUND IN HOSPITALIZED OLDER ADULTS" (ECOSARC): multi-centre, prospective observational study protocol. BMC Geriatr. 2023 Mar 22;23(1):163. doi: 10.1186/s12877-023-03891-5.'}]}, 'descriptionModule': {'briefSummary': 'Observational prospective study in older adults admitted to an Acute Geriatric Unit, in which sarcopenia will be evaluated by ultrasound in the anterior rectus femoris muscle.', 'detailedDescription': 'The main objective of the study is to estimate, by means of portable ultrasound, parameters of muscle quantity and quality (anterior rectus femoris muscle area, width and echostructure ) in older adults hospitalized in Acute Geriatric Units for medical reasons.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '69 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients over 69 years of age admitted to Acute Geriatric Units.', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patients over 69 years of age.\n* Hospitalization for a medical cause in Acute Geriatric Units.\n* Holden's Functional Ambulation Classification Scale at level 1 or higher.\n* Informed consent signed by the patient or legal representative.\n\nExclusion Criteria:\n\n* Terminal condition or life expectancy of less than 6 months.\n* Impossibility or refusal to undergo muscle ultrasound.\n* Refusal for follow-up\n* Severe dementia stage Global Deteriorating Scale: 7\n* Impossibility in the opinion of the investigators to complete the necessary data for the study."}, 'identificationModule': {'nctId': 'NCT05113758', 'acronym': 'ECOSARC', 'briefTitle': 'Sarcopenia Measured by Ultrasound in Hospitalized Older Adults', 'organization': {'class': 'OTHER', 'fullName': 'Complejo Hospitalario Universitario de Albacete'}, 'officialTitle': '"SARCOPENIA MEASURED BY ULTRASOUND IN HOSPITALIZED OLDER ADULTS" (ECOSARC Study).', 'orgStudyIdInfo': {'id': 'ABZ-ECO-2018-01'}}, 'armsInterventionsModule': {'interventions': [{'name': 'muscle ultrasound', 'type': 'DIAGNOSTIC_TEST', 'description': 'All participants will undergo a muscle ultrasound on admission and at discharge'}]}, 'contactsLocationsModule': {'locations': [{'zip': '02006', 'city': 'Albacete', 'country': 'Spain', 'facility': 'Complejo Hospitalario Universitario de Albacete', 'geoPoint': {'lat': 38.99424, 'lon': -1.85643}}], 'overallOfficials': [{'name': 'Pedro Abizanda, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Complejo Hospitalario Universitario de Albacete (SESCAM)'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pedro Abizanda', 'class': 'OTHER'}, 'collaborators': [{'name': 'Hospital Universitario Getafe', 'class': 'OTHER'}, {'name': 'Hospital Infanta Sofia', 'class': 'OTHER'}, {'name': 'Hospital Universitario Infanta Leonor', 'class': 'OTHER'}, {'name': 'Hospital Universitario La Paz', 'class': 'OTHER'}, {'name': 'Puerta de Hierro University Hospital', 'class': 'OTHER'}, {'name': 'Hospital Virgen del Valle de Toledo', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Pedro Abizanda', 'investigatorAffiliation': 'Complejo Hospitalario Universitario de Albacete'}}}}