Ignite Creation Date:
2025-12-25 @ 5:00 AM
Ignite Modification Date:
2026-01-29 @ 4:19 AM
Study NCT ID:
NCT06122818
Status:
COMPLETED
Last Update Posted:
2024-11-20
First Post:
2023-11-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of Sarcopenia in Patients Receiving Home Health Care
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': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 120}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-11-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-11', 'completionDateStruct': {'date': '2024-10-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-11-18', 'studyFirstSubmitDate': '2023-11-03', 'studyFirstSubmitQcDate': '2023-11-03', 'lastUpdatePostDateStruct': {'date': '2024-11-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-11-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-10-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'handgrip strength', 'timeFrame': 'three months', 'description': 'Handgrip strength will be measured using a hand grip dynamometer. Measurements will be taken 3 times in a sitting position with the elbow flexed to 90° and the wrist in neutral position. The measured maximal grip strength will be recorded as hand grip strength. The measurement will be repeated 3 months after the first measurement'}, {'measure': 'calf circumference', 'timeFrame': 'three months', 'description': "Calf circumference is an anthropometric measurement that indicates fat free muscle mass and has been considered by the World Health Organization (WHO) the most sensitive index for evaluating the decrease in muscle mass. Calf circumference will be measured with an elastic band over the subject's right leg, both sitting and standing. The measurement will be repeated 3 months after the first measurement"}, {'measure': 'Body Mass Index (BMI)', 'timeFrame': 'three months', 'description': 'BMI will be calculated as weight (kg) divided by height2 (m2). The measurement will be repeated 3 months after the first measurement'}, {'measure': 'Skeletal muscle mass', 'timeFrame': 'three months', 'description': 'Skeletal muscle mass will be evaluated using a multi-frequency body composition analysis device. The measurement will be repeated 3 months after the first measurement'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Sarcopenia', 'home health care'], 'conditions': ['Sarcopenia', 'Home Health Care']}, 'referencesModule': {'references': [{'pmid': '36554892', 'type': 'BACKGROUND', 'citation': 'Hua N, Zhang Y, Tan X, Liu L, Mo Y, Yao X, Wang X, Wiley J, Wang X. Nutritional Status and Sarcopenia in Nursing Home Residents: A Cross-Sectional Study. Int J Environ Res Public Health. 2022 Dec 18;19(24):17013. doi: 10.3390/ijerph192417013.'}, {'pmid': '34379741', 'type': 'BACKGROUND', 'citation': 'De Spiegeleer A, Kahya H, Sanchez-Rodriguez D, Piotrowicz K, Surquin M, Marco E, Detremerie C, Hussein D, Hope S, Dallmeier D, Decker G, Hrnciarikova D, Czesak J, Toscano-Rico M, Meza-Valderrama D, Bahat G, Descamps A, Wynendaele E, Elewaut D, Vankova H, Landi F, Benoit F, Gasowski J, Van Den Noortgate N. Acute sarcopenia changes following hospitalization: influence of pre-admission care dependency level. Age Ageing. 2021 Nov 10;50(6):2140-2146. doi: 10.1093/ageing/afab163.'}, {'pmid': '35029041', 'type': 'BACKGROUND', 'citation': 'Thompson MQ, Jadczak AD, Yu S, Tucker GR, Visvanathan R. Sarcopenia risk in nursing home residents using SARC-F: FIRST study findings. Geriatr Gerontol Int. 2022 Mar;22(3):206-212. doi: 10.1111/ggi.14327. Epub 2022 Jan 13.'}, {'pmid': '29555099', 'type': 'BACKGROUND', 'citation': 'Kamo T, Ishii H, Suzuki K, Nishida Y. Prevalence of sarcopenia and its association with activities of daily living among japanese nursing home residents. Geriatr Nurs. 2018 Sep-Oct;39(5):528-533. doi: 10.1016/j.gerinurse.2018.02.011. Epub 2018 Mar 16.'}, {'pmid': '33183542', 'type': 'BACKGROUND', 'citation': 'Fashho E, Ahmed T, Garden G, Readman D, Storey L, Wilkinson L, Wilson G, Slee A. Investigating the prevalence of malnutrition, frailty and physical disability and the association between them amongst older care home residents. Clin Nutr ESPEN. 2020 Dec;40:231-236. doi: 10.1016/j.clnesp.2020.09.014. Epub 2020 Sep 22.'}]}, 'descriptionModule': {'briefSummary': 'The aim in the study is to evaluate the presence of sarcopenia in patients receiving home health care; To evaluate the relationship between sarcopenia and age, disease duration, and cause of immobility. In the literature review, a limited number of studies evaluating sarcopenia in home health patients were found.', 'detailedDescription': 'Home Health Service is the provision of health services needed by immobile and chronic disease patients in the home environment. The purpose of this service is not to diagnose the patient, but rather to follow up, implement and educate the treatment of the diagnosed patient.\n\nThe aim of the study is to evaluate the presence of sarcopenia in patients receiving home health care; To evaluate the relationship between sarcopenia and age, disease duration, and cause of immobility. In the literature review, a limited number of studies evaluating sarcopenia in home health patients were found.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Immobile patients receiving home health care', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Receiving home health care\n2. Being at the mental and physical activity level to be able to perform and complete the tests\n3. Being 18-85 years old\n\nExclusion Criteria:\n\n1\\) Patients who cannot cooperate'}, 'identificationModule': {'nctId': 'NCT06122818', 'briefTitle': 'Evaluation of Sarcopenia in Patients Receiving Home Health Care', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Istanbul Physical Medicine Rehabilitation Training and Research Hospital'}, 'officialTitle': 'Evaluation of Sarcopenia in Patients Receiving Home Health Care', 'orgStudyIdInfo': {'id': 'IstanbulPMRTRHomecare-srcpn'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Immobile patients receiving home health care', 'type': 'OTHER', 'description': 'Demographic characteristics, duration of immobility, sarcopenia presence, thigh circumference , Hand grip strength , bioelectrical impedance analysis'}]}, 'contactsLocationsModule': {'locations': [{'zip': '34192', 'city': 'Istanbul', 'country': 'Turkey (Türkiye)', 'facility': 'Istanbul Physical Medicine Rehabilitation Training and Research Hospital', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}], 'overallOfficials': [{'name': 'Tugba aydın', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Istanbul Physical Medicine Rehabilitation Training and Research Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Istanbul Physical Medicine Rehabilitation Training and Research Hospital', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Tuğba Aydın', 'investigatorAffiliation': 'Istanbul Physical Medicine Rehabilitation Training and Research Hospital'}}}}