Ignite Creation Date:
2025-12-25 @ 4:14 AM
Ignite Modification Date:
2025-12-26 @ 3:13 AM
Study NCT ID:
NCT05019820
Status:
UNKNOWN
Last Update Posted:
2021-08-25
First Post:
2021-07-23
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Identification of Sarcopenia in Knee Osteoarthritis With Ultrasonography and Evaluation of Muscle Architecture Change by Ultrasonography After Isokinetic Exercise Program
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020370', 'term': 'Osteoarthritis, Knee'}, {'id': 'D055948', 'term': 'Sarcopenia'}], 'ancestors': [{'id': 'D010003', 'term': 'Osteoarthritis'}, {'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}, {'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': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-08-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-08', 'completionDateStruct': {'date': '2022-12-13', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-08-19', 'studyFirstSubmitDate': '2021-07-23', 'studyFirstSubmitQcDate': '2021-08-19', 'lastUpdatePostDateStruct': {'date': '2021-08-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-08-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-11-20', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Muscle architecture', 'timeFrame': 'Six weeks', 'description': 'Determination of muscle architecture change with ultrasonography after isokinetic exercise'}], 'secondaryOutcomes': [{'measure': 'Knee pain', 'timeFrame': 'Six weeks', 'description': 'The effect of isokinetic exercise with VAS (visual analog scale) on pain level'}, {'measure': 'Functional status', 'timeFrame': 'Six weeks', 'description': 'Effect of isokinetic exercise on activities of daily living with WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index)'}, {'measure': 'Hand grip strength', 'timeFrame': 'Six weeks', 'description': 'Evaluating the effect of isokinetic exercise on hand grip strength with a hand dynamometer'}, {'measure': 'Walking speed', 'timeFrame': 'Six weeks', 'description': 'Evaluation of the change in walking speed with isokinetic exercise'}, {'measure': 'Time to get out of the chair', 'timeFrame': 'Six weeks', 'description': 'Evaluation of the change in sitting time by standing up from the chair 5 times with isokinetic exercise'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Osteoarthritis of the Knee', 'Sarcopenia']}, 'referencesModule': {'references': [{'pmid': '30657091', 'type': 'BACKGROUND', 'citation': 'Spinoso DH, Bellei NC, Marques NR, Navega MT. Quadriceps muscle weakness influences the gait pattern in women with knee osteoarthritis. Adv Rheumatol. 2018 Aug 31;58(1):26. doi: 10.1186/s42358-018-0027-7.'}, {'pmid': '18821647', 'type': 'BACKGROUND', 'citation': 'Lange AK, Vanwanseele B, Fiatarone Singh MA. Strength training for treatment of osteoarthritis of the knee: a systematic review. Arthritis Rheum. 2008 Oct 15;59(10):1488-94. doi: 10.1002/art.24118.'}, {'pmid': '30312372', 'type': 'BACKGROUND', 'citation': 'Cruz-Jentoft AJ, Bahat G, Bauer J, Boirie Y, Bruyere O, Cederholm T, Cooper C, Landi F, Rolland Y, Sayer AA, Schneider SM, Sieber CC, Topinkova E, Vandewoude M, Visser M, Zamboni M; Writing Group for the European Working Group on Sarcopenia in Older People 2 (EWGSOP2), and the Extended Group for EWGSOP2. Sarcopenia: revised European consensus on definition and diagnosis. Age Ageing. 2019 Jan 1;48(1):16-31. doi: 10.1093/ageing/afy169.'}, {'pmid': '32941253', 'type': 'BACKGROUND', 'citation': 'Kara M, Kaymak B, Ata AM, Ozkal O, Kara O, Baki A, Sengul Aycicek G, Topuz S, Karahan S, Soylu AR, Cakir B, Halil M, Ozcakar L. STAR-Sonographic Thigh Adjustment Ratio: A Golden Formula for the Diagnosis of Sarcopenia. Am J Phys Med Rehabil. 2020 Oct;99(10):902-908. doi: 10.1097/PHM.0000000000001439.'}, {'pmid': '24482109', 'type': 'BACKGROUND', 'citation': 'Papalia R, Zampogna B, Torre G, Lanotte A, Vasta S, Albo E, Tecame A, Denaro V. Sarcopenia and its relationship with osteoarthritis: risk factor or direct consequence? Musculoskelet Surg. 2014 Jun;98(1):9-14. doi: 10.1007/s12306-014-0311-6. Epub 2014 Jan 31.'}, {'pmid': '23852989', 'type': 'BACKGROUND', 'citation': 'Baroni BM, Geremia JM, Rodrigues R, De Azevedo Franke R, Karamanidis K, Vaz MA. Muscle architecture adaptations to knee extensor eccentric training: rectus femoris vs. vastus lateralis. Muscle Nerve. 2013 Oct;48(4):498-506. doi: 10.1002/mus.23785. Epub 2013 Jul 15.'}, {'pmid': '29035179', 'type': 'RESULT', 'citation': 'Lespasio MJ, Piuzzi NS, Husni ME, Muschler GF, Guarino A, Mont MA. Knee Osteoarthritis: A Primer. Perm J. 2017;21:16-183. doi: 10.7812/TPP/16-183.'}]}, 'descriptionModule': {'briefSummary': 'The aim of this thesis; To define sarcopenia in knee osteoarthritis with ultrasonography and to evaluate changes in muscle structure in sarcopenia after isokinetic exercise application ultrasonographically. The investigators will evaluate the effect of isokinetic exercise therapy in sarcopenic patients with knee osteoarthritis with VAS (Visual Analog Scale) and WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index). Then, the hand grip strength will be evaluated with a dynamometer, and its effects on physical performance will be evaluated by 6 meters walking and chair rising tests.', 'detailedDescription': 'Among the 45-65 age group who applied to Mustafa Kemal University Faculty of Medicine, Physical Medicine and Rehabilitation outpatient clinic, 30 female patients diagnosed with knee osteoarthritis (stage 1-2-3) and sarcopenia together, and 30 individuals without osteoarthritis and sarcopenia will be included in the study as the control group.Patients with knee osteoarthritis who have been diagnosed with sarcopenia by ultrasonography will be Group I, and the control group without osteoarthritis and sarcopenia will be Group II.30 patients in Group I will be given an exercise program with isokinetic dynamometer for both knees, 30 minutes of TENS (transcutaneous electrical nerve stimulation), 20 minutes of hot packs, and home exercise program will be given lower extremity strengthening for a total of 6 weeks (18 sessions), 3 sessions per week.A diet program (protein, mineral, vitamin D supplemented) will also be given to these patients. The control group, which is group II, will be offered a home exercise program and diet for lower extremity strengthening only.Those with a history of complicated Diabetes Mellitus, Severe Coronary Artery Disease / Congestive Heart Failure, severe Liver Failure, neuromuscular disease, previous lower extremity surgery, rheumatological disease, use of walking aids will not be included in the study.The patient group and control group pre-treatment (week 0) and post-treatment (week 6) clinical; hand grip strength will be evaluated with Jamar dynamometer, walking speed will be evaluated with 6 meters walking test, lower extremity endurance will be evaluated with chair rise test, functional assessment of knee osteoarthritis will be evaluated by WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index) and pain assessment will be evaluated by VAS (Visual Analogue scale) will be evaluated with a pain questionnaire.In addition, changes in the Rectus Femoris and Vastus Lateralis muscle architecture on the dominant side of the patients; muscle thickness, fascicle length, echogenicity, pennation angle and cross-sectional area measurements will be evaluated before treatment (0 weeks) and after treatment (6 weeks) by ultrasonography.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '45 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Among the 45-65 age group, 30 female patients diagnosed with knee osteoarthritis (Stage 1-2-3) and sarcopenia together\n* Among the 45-65 age group, 30 females without osteoarthritis and sarcopenia will be included in the study as the control group.\n\nExclusion Criteria:\n\n* Diabetes Mellitus,\n* Severe Coronary Artery Disease / Congestive Heart Failure,\n* Severe Liver Failure,\n* Neuromuscular disease,\n* Lower extremity surgery,\n* Rheumatological disease,\n* Those who use walking aids'}, 'identificationModule': {'nctId': 'NCT05019820', 'briefTitle': 'Identification of Sarcopenia in Knee Osteoarthritis With Ultrasonography and Evaluation of Muscle Architecture Change by Ultrasonography After Isokinetic Exercise Program', 'organization': {'class': 'OTHER', 'fullName': 'Mustafa Kemal University'}, 'officialTitle': 'Identification of Sarcopenia in Knee Osteoarthritis With Ultrasonography and Evaluation of Muscle Architecture Change by Ultrasonography After Isokinetic Exercise Program', 'orgStudyIdInfo': {'id': 'MustafaKU-Sar-KOA'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Sarcopenia and osteoarthritis group', 'description': 'Women aged 45-65 years diagnosed with sarcopenia and knee osteoarthritis', 'interventionNames': ['Other: Knee strengthening exercises with isokinetic dynamometer']}, {'type': 'OTHER', 'label': 'Without osteoarthritis and sarcopenia group', 'description': 'Women aged 45-65 years without a diagnosis of knee osteoarthritis and sarcopenia', 'interventionNames': ['Other: Strengthening around the knees with home exercise programe']}], 'interventions': [{'name': 'Knee strengthening exercises with isokinetic dynamometer', 'type': 'OTHER', 'description': '18 sessions of strengthening exercises around the knee with an isokinetic dynamometer 3 days a week', 'armGroupLabels': ['Sarcopenia and osteoarthritis group']}, {'name': 'Strengthening around the knees with home exercise programe', 'type': 'OTHER', 'description': '18 sessions of strengthening exercises for the muscles around the knee at home, 3 days a week', 'armGroupLabels': ['Without osteoarthritis and sarcopenia group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '31000', 'city': 'Hatay', 'state': 'Antakya', 'status': 'RECRUITING', 'country': 'Turkey (Türkiye)', 'contacts': [{'name': 'HASAN KAYA', 'role': 'CONTACT', 'email': 'rektorlukyaziisleri@mku.edu.tr', 'phone': '+90 (326) 221 33 17'}, {'role': 'CONTACT', 'email': 'semaadagci@gmail.com', 'phone': '+90 (326) 221 33 18'}], 'facility': 'Hatay Mustafa Kemal University', 'geoPoint': {'lat': 38.40227, 'lon': 27.10486}}], 'centralContacts': [{'name': 'Sema Dagci, M.D.', 'role': 'CONTACT', 'email': 'semaadagci@gmail.com', 'phone': '+90 326 229 10 00', 'phoneExt': '5067'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sema Dağcı', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Sema Dağcı', 'investigatorAffiliation': 'Mustafa Kemal University'}}}}