Ignite Creation Date:
2025-12-25 @ 2:05 AM
Ignite Modification Date:
2025-12-26 @ 5:52 AM
Study NCT ID:
NCT04227860
Status:
COMPLETED
Last Update Posted:
2022-05-26
First Post:
2020-01-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Balance and Strength Exercise in Knee Osteoarthritis Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, '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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR'], 'maskingDescription': 'Post-exercise training assessment will be done by an investigator not involved in the study and unaware of the grading of KOA or of the pre-exercise assessment.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 80}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-01-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-05', 'completionDateStruct': {'date': '2021-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-05-25', 'studyFirstSubmitDate': '2020-01-09', 'studyFirstSubmitQcDate': '2020-01-13', 'lastUpdatePostDateStruct': {'date': '2022-05-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-01-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-06-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Assessment of pain', 'timeFrame': '2-6 weeks', 'description': 'Using the Western Ontario and McMaster University Osteoarthritis Index (WOMAC), which contains pain sub-score and a overall total score. The higher the score the worst the pain.'}, {'measure': 'Assessment of stiffness', 'timeFrame': '2-6 weeks', 'description': 'Using the Western Ontario and McMaster University Osteoarthritis Index (WOMAC), which contains stiffness sub-score and a overall total score. The higher the score the worst the stiffness.'}, {'measure': 'Assessment of physical function', 'timeFrame': '2-6 weeks', 'description': 'Using the time up and go test, where the patient is seated and asked to get up walk a distance turn around and return to chair and sit again. It is measured using a timer, the longer the patient takes the worst the physical function of the patient.'}], 'secondaryOutcomes': [{'measure': 'Dynamic Balance', 'timeFrame': '2-6 weeks', 'description': 'Using the Modified star excursion balance test which measures the patients dynamic balance in several directions, giving the patient 3 attempts and measuring each time and taking a mean of the 3 measurements in each. An increase in the measurements means better dynamic balance and a smaller measurement means worse dynamic balance.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Knee Osteoarthritis']}, 'descriptionModule': {'briefSummary': 'The aim of this study is to assess the effect of balance exercise on dynamic balance and physical function in 80 patients with different grades of primary knee osteoarthritis (KOA).', 'detailedDescription': 'The study will include 80 patients with primary knee osteoarthritis divided into 4 groups according to the Kellgren and Lawrence grading scale (KL):\n\nGroup 1: 20 patients with grade I KOA Group 2: 20 patients with grade II KOA Group 3: 20 patients with grade III KOA Group 4: 20 patients with grade IV KOA\n\n* Patients will undergo pre-exercise and post- exercise assessment with:\n\n 1. Western Ontario and McMaster University Osteoarthritis Index (WOMAC)\n 2. Modified Stare Excursion Balance test\n 3. Timed up and Go test\n* Exercise program includes:\n\n 1. Lower extremity kinesthesia and balance exercise program\n 2. Strength exercise program'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with primary knee osteoarthritis according to the EULAR recommendations 2010.\n* Patients can complete at least stage 1 of balance and exercise program (minimum of 2 weeks)\n\nExclusion Criteria:\n\n* Patients that cannot complete at least stage 1 of balance and exercise program\n* Patients with medical conditions affecting postural balance including visual, inner ear and neurological problems.\n* Patients with lower limb joint or bony problems other than primary knee osteoarthritis .\n* Patients with secondary KOA.\n* Patients who received intra- articular joint injection in 1 or both knees in the past 90 days.'}, 'identificationModule': {'nctId': 'NCT04227860', 'briefTitle': 'Balance and Strength Exercise in Knee Osteoarthritis Patients', 'organization': {'class': 'OTHER', 'fullName': 'University of Alexandria'}, 'officialTitle': 'The Effect of Combined Balance and Strength Exercise Program in Patients With Different Grades of Primary Knee Osteoarthritis Patients', 'orgStudyIdInfo': {'id': '0105852'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Group 1: G I primary KOA', 'description': 'Exercise and balance training', 'interventionNames': ['Other: Balance exercise program', 'Other: Strengthening exercise program']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group 2: G II primary KOA', 'description': 'Exercise and balance training', 'interventionNames': ['Other: Balance exercise program', 'Other: Strengthening exercise program']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group 3: G III primary KOA', 'description': 'Exercise and balance training', 'interventionNames': ['Other: Balance exercise program', 'Other: Strengthening exercise program']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group 4: G IV primary KOA', 'description': 'Exercise and balance training', 'interventionNames': ['Other: Balance exercise program', 'Other: Strengthening exercise program']}], 'interventions': [{'name': 'Balance exercise program', 'type': 'OTHER', 'description': 'Patients will be engaged in lower extremity kinesthesia and balance exercise program 3 time per week for 6 weeks.\n\nDivided into 2 stages, stage 1 and 2, each stage 3 weeks. Patients who fulfill at least stage 1 of the program will be included in the study.', 'armGroupLabels': ['Group 1: G I primary KOA', 'Group 2: G II primary KOA', 'Group 3: G III primary KOA', 'Group 4: G IV primary KOA']}, {'name': 'Strengthening exercise program', 'type': 'OTHER', 'description': 'Patients will be engaged in strengthening exercise program 3 time per week for 6 weeks.\n\nDivided into 3 stages, stage 1, 2 and 3, each stage 2 weeks. Patients who fulfill at least stage 1 of the program will be included in the study.', 'armGroupLabels': ['Group 1: G I primary KOA', 'Group 2: G II primary KOA', 'Group 3: G III primary KOA', 'Group 4: G IV primary KOA']}]}, 'contactsLocationsModule': {'locations': [{'zip': '00123', 'city': 'Alexandria', 'country': 'Egypt', 'facility': 'Alexandria University, Faculty of Medicine', 'geoPoint': {'lat': 31.20176, 'lon': 29.91582}}], 'overallOfficials': [{'name': 'Yousra H Abdel Fattah', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Alexandria University Faculty of Medicine'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Alexandria', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Lecturer of Physical Medicine, Rheumatology and Rehabilitation', 'investigatorFullName': 'Yousra Hisham Abdel Fattah', 'investigatorAffiliation': 'University of Alexandria'}}}}