Ignite Creation Date:
2026-03-26 @ 3:16 PM
Ignite Modification Date:
2026-03-31 @ 1:52 AM
Study NCT ID:
NCT07482332
Status:
RECRUITING
Last Update Posted:
2026-03-19
First Post:
2026-03-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Core Stabilization Exercises in Female Patients With Gonarthrosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020370', 'term': 'Osteoarthritis, Knee'}], 'ancestors': [{'id': 'D010003', 'term': 'Osteoarthritis'}, {'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D004561', 'term': 'Transcutaneous Electric Nerve Stimulation'}, {'id': 'D019220', 'term': 'High-Energy Shock Waves'}], 'ancestors': [{'id': 'D004599', 'term': 'Electric Stimulation Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D026741', 'term': 'Physical Therapy Modalities'}, {'id': 'D012046', 'term': 'Rehabilitation'}, {'id': 'D000698', 'term': 'Analgesia'}, {'id': 'D000760', 'term': 'Anesthesia and Analgesia'}, {'id': 'D000069453', 'term': 'Ultrasonic Waves'}, {'id': 'D013016', 'term': 'Sound'}, {'id': 'D011840', 'term': 'Radiation, Nonionizing'}, {'id': 'D011827', 'term': 'Radiation'}, {'id': 'D055585', 'term': 'Physical Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Paralel Randomized'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2026-01-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-03', 'completionDateStruct': {'date': '2026-09-14', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-03-16', 'studyFirstSubmitDate': '2026-03-16', 'studyFirstSubmitQcDate': '2026-03-16', 'lastUpdatePostDateStruct': {'date': '2026-03-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-08-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Sit Ups', 'timeFrame': 'Baseline-6 weeks follow-up', 'description': 'Participants are positioned supine with knees flexed and hands crossed over their shoulders. Their feet are held in place by the researcher, and the individual is asked to perform trunk flexion. The number of repetitions completed within 30 seconds is recorded.'}, {'measure': 'Modified Push-Up', 'timeFrame': 'Baseline-6 weeks follow-up', 'description': 'Participants lie face down on an exercise mat with their knees flexed. They are asked to lift their head, torso, and hips off the ground, placing their hands on the floor and extending their elbows, so that they form a straight line. The number of complete repetitions the participant performs while maintaining this straight line within 30 seconds is recorded.'}, {'measure': 'Core Endurance Tests', 'timeFrame': 'Baseline-6 weeks follow-up', 'description': 'Core endurance is determined by core endurance tests (right and left lateral bridge test, trunk extension test, trunk flexion test), as defined by McGgill, and the prone bridge test.'}], 'secondaryOutcomes': [{'measure': '30-Second Sit-Stand Test', 'timeFrame': 'Baseline-6 weeks follow-up', 'description': 'Used to assess lower extremity muscle strength. The participant sits in the middle of a chair with no armrests, back support, and a seat height of 44 cm, with their arms crossed at chest level. Upon the command "Start," the participant is asked to fully stand up and sit down as quickly as possible without losing their balance for 30 seconds. The number of complete sit-ups and stands within 30 seconds is recorded as a score.'}, {'measure': 'Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)', 'timeFrame': 'Baseline-6 weeks follow-up', 'description': 'The index is a validated, multidimensional, patient-reported assessment tool used to evaluate pain, stiffness, and physical function in patients with knee osteoarthritis. The index consists of three subcategories and a total of 24 items: pain (5 questions; 0-20 points), stiffness (2 questions; 0-8 points), and physical function (17 questions; 0-68 points). Each item is worth 0-4 points. The total score ranges from 0 to 96. In all subcategories and the total score, higher scores indicate worse health status, while lower scores indicate better health status.'}, {'measure': 'Single Leg Balance Test', 'timeFrame': 'Baseline-6 weeks follow-up', 'description': 'Participants were asked to stand on one leg on a hard surface, ensuring that the unsupported leg did not touch the other leg and without using external support. The procedure was repeated three times for each participant, and the highest value obtained was used in the statistical analysis phase. The timer was started the moment the participant lifted the supporting leg; it was stopped when the balance was lost, when the unsupported leg touched the ground, or when external support was applied. This test was repeated on both the right and left sides.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Knee osteoarthritis', 'Core stabilization exercise', 'Physiotherapy', 'Function'], 'conditions': ['Knee Osteoarthritis (Knee OA)']}, 'descriptionModule': {'briefSummary': 'Osteoarthritis (OA) is a non-inflammatory degenerative disease characterized by progressive deterioration of cartilage tissue, synovial membrane, and joint capsule, primarily affecting weight-bearing joints. Individuals with knee osteoarthritis exhibit weakness in the trunk and periarticular muscles. This loss of strength in the trunk and periarticular muscles increases the load on the joint, contributing to the development and progression of the disease. This study aimed to investigate the effects of core stabilization, applied in addition to knee muscle exercise programs, on clinical symptoms and functional capacity in individuals with knee osteoarthritis.', 'detailedDescription': 'Osteoarthritis is the most common chronic joint disease and a leading cause of disability worldwide. It represents a significant public health and cost problem due to reduced work productivity and early retirement. OA is a non-inflammatory degenerative disease characterized by progressive deterioration of cartilage tissue, synovial membrane, and joint capsule, particularly in weight-bearing joints, along with a series of biochemical and morphological changes. While its etiology is not fully understood, it is considered a multifactorial disease involving a combination of systemic and regional factors. Increased bone density, joint laxity, and excessive mechanical loading are some of these factors. Symptoms of knee osteoarthritis include pain, joint stiffness, swelling, loss of function, and muscle weakness. Pain and joint stiffness in individuals negatively affect daily living activities such as climbing stairs, walking, and running, leading to decreased functionality. Current literature emphasizes that strong proximal trunk stabilization is needed for safe and effective completion of movements in the distal segments, and that weakness in this region is directly related to lower extremity pain. This study aimed to investigate the effects of core stabilization, applied in addition to an exercise program for the knee muscles, on clinical symptoms and functional capacity in individuals with knee osteoarthritis.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '45 Years', 'genderBased': True, 'genderDescription': 'Female', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Kellgren-Lawrence 2-3 knee osteoarthritis\n* Female patient aged 40-65\n* Volunteer\n\nExclusion Criteria:\n\n* Having received physical therapy within the last month\n* Presence of neurological, cardiac, and respiratory problems\n* Less than 90 degrees of flexion in the knee and hip joints\n* Presence of any pathology in the lower extremity that may affect balance and function\n* History of lower extremity surgery\n* Severe visual, hearing, and speech impairment\n* Illiteracy in Turkish\n* Body mass index of 30 or higher'}, 'identificationModule': {'nctId': 'NCT07482332', 'briefTitle': 'Effects of Core Stabilization Exercises in Female Patients With Gonarthrosis', 'organization': {'class': 'OTHER', 'fullName': 'Cumhuriyet University'}, 'officialTitle': 'Randomized Controlled Study of the Effects of Core Stabilization Exercises in Addition to Knee Exercises in Female Patients With Gonarthrosis', 'orgStudyIdInfo': {'id': 'SCU-FTR-SB-08'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Experimental Group', 'description': 'This group will receive 10 days of conventional physiotherapy (Hot Pack, TENS, Ultrasound) and 6 weeks of routine knee exercises + 6 weeks of core stabilization exercises.', 'interventionNames': ['Other: 10 days of conventional physiotherapy (Hot Pack, TENS, Ultrasound) and 6 weeks of routine knee exercises', 'Other: Six weeks of core stabilization exercises.']}, {'type': 'OTHER', 'label': 'Control Group', 'description': 'This group will receive 10 days of conventional physiotherapy (Hot Pack, TENS, Ultrasound) and 6 weeks of routine knee exercises.', 'interventionNames': ['Other: 10 days of conventional physiotherapy (Hot Pack, TENS, Ultrasound) and 6 weeks of routine knee exercises']}], 'interventions': [{'name': '10 days of conventional physiotherapy (Hot Pack, TENS, Ultrasound) and 6 weeks of routine knee exercises', 'type': 'OTHER', 'description': 'For 10 days, conventional physical therapy consisting of Hot Pack, TENS, Ultrasound, and routine knee strengthening exercises was applied in the hospital. These knee exercises were continued for four weeks after the hospital treatment period.', 'armGroupLabels': ['Control Group', 'Experimental Group']}, {'name': 'Six weeks of core stabilization exercises.', 'type': 'OTHER', 'description': 'For six weeks, Warner et al. A core stabilization exercise protocol, as defined by was provided. This protocol included neutral spine position in hook position, activation of deep abdominal muscles, supine bridge, ipsilateral and contralateral limb movements in hook position, abdominal curl (sit-up), bridge (double and single leg), plank on knees, side plank on knees, clam exercise (without resistance), and modified 100 exercises. The exercises were performed 3 days a week, with 10 repetitions each.', 'armGroupLabels': ['Experimental Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '58140', 'city': 'Sivas', 'status': 'RECRUITING', 'country': 'Turkey (Türkiye)', 'contacts': [{'name': 'Selvin Balki, Associate professor, Ph.D.', 'role': 'CONTACT', 'email': 'balkipt@gmail.com', 'phone': '+90 346 4870000', 'phoneExt': '2652'}, {'name': 'Eda Yıldırım, PT', 'role': 'CONTACT', 'email': 'edaayldrm7@gmail.com', 'phone': '+90 5056925334'}], 'facility': 'Sivas Cumhuriyet University', 'geoPoint': {'lat': 39.74833, 'lon': 37.01611}}], 'centralContacts': [{'name': 'Selvin Balki, Associate Professor, Ph.D.', 'role': 'CONTACT', 'email': 'balkipt@gmail.com', 'phone': '+90 346 4870000', 'phoneExt': '2652'}, {'name': 'Eda Yıldırım, PT', 'role': 'CONTACT', 'email': 'edaayldrm7@gmail.com', 'phone': '+90 5056925334'}], 'overallOfficials': [{'name': 'Selvin Balki', 'role': 'STUDY_CHAIR', 'affiliation': 'Cumhuriyet University'}, {'name': 'Eda Yıldırım', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Cumhuriyet University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cumhuriyet University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate professor, Ph.D.', 'investigatorFullName': 'Selvin BALKİ', 'investigatorAffiliation': 'Cumhuriyet University'}}}}