Ignite Creation Date:
2025-12-24 @ 10:16 PM
Ignite Modification Date:
2026-01-26 @ 8:14 PM
Study NCT ID:
NCT05638035
Status:
UNKNOWN
Last Update Posted:
2022-12-06
First Post:
2022-11-25
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Obesity on Rectus Femoris Muscle Thickness, Sarcopenia, Gait and Balance in Women
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D055948', 'term': 'Sarcopenia'}, {'id': 'D009765', 'term': 'Obesity'}], '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'}, {'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001835', 'term': 'Body Weight'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2022-10-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-11', 'completionDateStruct': {'date': '2023-06-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-11-25', 'studyFirstSubmitDate': '2022-11-25', 'studyFirstSubmitQcDate': '2022-11-25', 'lastUpdatePostDateStruct': {'date': '2022-12-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-12-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-03-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Rectus femoris muscle thickness', 'timeFrame': 'baseline', 'description': 'Measurement of muscle thickness with ultrasound'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Sarcopenic Obesity', 'Sarcopenia', 'Obesity']}, 'referencesModule': {'references': [{'pmid': '26655919', 'type': 'BACKGROUND', 'citation': 'Mueller N, Murthy S, Tainter CR, Lee J, Riddell K, Fintelmann FJ, Grabitz SD, Timm FP, Levi B, Kurth T, Eikermann M. Can Sarcopenia Quantified by Ultrasound of the Rectus Femoris Muscle Predict Adverse Outcome of Surgical Intensive Care Unit Patients as well as Frailty? A Prospective, Observational Cohort Study. Ann Surg. 2016 Dec;264(6):1116-1124. doi: 10.1097/SLA.0000000000001546.'}, {'pmid': '22318311', 'type': 'BACKGROUND', 'citation': 'Dutil M, Handrigan GA, Corbeil P, Cantin V, Simoneau M, Teasdale N, Hue O. The impact of obesity on balance control in community-dwelling older women. Age (Dordr). 2013 Jun;35(3):883-90. doi: 10.1007/s11357-012-9386-x. Epub 2012 Feb 10.'}, {'pmid': '31898170', 'type': 'BACKGROUND', 'citation': 'Ates Bulut E, Soysal P, Dokuzlar O, Kocyigit SE, Aydin AE, Yavuz I, Isik AT. Validation of population-based cutoffs for low muscle mass and strength in a population of Turkish elderly adults. Aging Clin Exp Res. 2020 Sep;32(9):1749-1755. doi: 10.1007/s40520-019-01448-4. Epub 2020 Jan 2.'}]}, 'descriptionModule': {'briefSummary': 'Research; It is a planned, non-invasive, controlled study in obese female volunteers and non-obese female volunteers. The population of the study consists of voluntarily non-obese women and obese women. Sarcopenia assets of individuals will be measured with the sarc-f questionnaire, and then muscle strength, muscle mass and physical performance tests will be measured. Then, rectus femoris muscle thickness will be measured with USG, and then walking and balance will be measured with ZEBRIS.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'genderBased': True, 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The population of the research consists of voluntarily non-obese women residing in Kütahya/Center and obese women voluntarily participating in the study at Kütahya Evliya Çelebi Training and Research Hospital Physical Therapy and Rehabilitation Hospital Obesity School.', 'genderDescription': 'Only women will be included in the study.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Being over 18 years old and female\n* Volunteering and accepting to participate in the study\n* BMI 30-39.9 kg/m2 in obese women (experimental group)\n* BMI 18-27.9 kg/m2 in non-obese women (control group)\n* Not having cardiorespiratory, neurological, orthopedic and metabolic disorders\n\nExclusion Criteria:\n\n* Being under 18 years old and male\n* Having a BMI of 40.0 kg/m2 and above in obese women (experimental group)\n* BMI 28.0 kg/m2 and above in non-obese women (control group)\n* Having cardiorespiratory, neurological, orthopedic and metabolic disorders'}, 'identificationModule': {'nctId': 'NCT05638035', 'briefTitle': 'Effects of Obesity on Rectus Femoris Muscle Thickness, Sarcopenia, Gait and Balance in Women', 'organization': {'class': 'OTHER', 'fullName': 'Kutahya Health Sciences University'}, 'officialTitle': 'Effects of Obesity on Rectus Femoris Muscle Thickness, Sarcopenia, Gait and Balance in Women', 'orgStudyIdInfo': {'id': 'DSA2022'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'non-obese women', 'description': 'After obtaining demographic information for women with a BMI of 18-27.9 kg/m2 for at least 6 months, Body Mass Index (BMI) will be calculated and the relationship between rectus femoris muscle thickness, sarcopenia, gait and balance will be evaluated and will be compared with obese group.', 'interventionNames': ['Diagnostic Test: Ultrasonografi, Sarcopenia measurement, Zebris']}, {'label': 'obese women', 'description': 'After obtaining demographic information in women with a BMI of 30-39.9 kg/m2, Body Mass Index (BMI) will be calculated and the relationship between obesity and rectus femoris muscle thickness, sarcopenia, gait and balance will be evaluated.', 'interventionNames': ['Diagnostic Test: Ultrasonografi, Sarcopenia measurement, Zebris']}], 'interventions': [{'name': 'Ultrasonografi, Sarcopenia measurement, Zebris', 'type': 'DIAGNOSTIC_TEST', 'description': 'The rectus femoris muscle thickness of the participants will be performed in B mode via USG (Mindray-UMT 200,USA) with a multifrequency (7-15 MHz) linear probe and the measurement will be reported.\n\nTANITA for sarcopenia, hand grip strength and walking speed will be evaluated.\n\nGait time-distance parameters and Static balance COP parameters (COP speed (cm/s) and COP length (cm)) will be recorded using Zebris™ FDM-2.', 'armGroupLabels': ['non-obese women', 'obese women']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Kütahya', 'state': 'Centre', 'country': 'Turkey (Türkiye)', 'facility': 'Kütahya Health Sciences University', 'geoPoint': {'lat': 39.42417, 'lon': 29.98333}}], 'overallOfficials': [{'name': 'yagmur kuralay', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'kütahya health sciences university'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kutahya Health Sciences University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'physiotherapist', 'investigatorFullName': 'Yağmur KURALAY', 'investigatorAffiliation': 'Kutahya Health Sciences University'}}}}