Ignite Creation Date:
2025-12-25 @ 2:37 AM
Ignite Modification Date:
2025-12-31 @ 10:48 PM
Study NCT ID:
NCT06574334
Status:
COMPLETED
Last Update Posted:
2024-08-27
First Post:
2024-08-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Proprioceptive Exercises on Joint Pain and QoL Among Geriatric Patients With Knee Osteoarthritis
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D052580', 'term': 'Muscle Stretching Exercises'}], 'ancestors': [{'id': 'D005081', 'term': 'Exercise Therapy'}, {'id': 'D012046', 'term': 'Rehabilitation'}, {'id': 'D000359', 'term': 'Aftercare'}, {'id': 'D003266', 'term': 'Continuity of Patient Care'}, {'id': 'D005791', 'term': 'Patient Care'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D026741', 'term': 'Physical Therapy Modalities'}, {'id': 'D015444', 'term': 'Exercise'}, {'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D009068', 'term': 'Movement'}, {'id': 'D009142', 'term': 'Musculoskeletal Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL', 'interventionModelDescription': '-Quasi experimental research design was used in this study'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 140}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-08', 'completionDateStruct': {'date': '2024-05-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-08-25', 'studyFirstSubmitDate': '2024-08-25', 'studyFirstSubmitQcDate': '2024-08-25', 'lastUpdatePostDateStruct': {'date': '2024-08-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-08-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-05-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Evaluate the effect of proprioceptive exercises on joint pain among geriatric patients with knee osteoarthritis', 'timeFrame': '3 months', 'description': 'By using Visual Analog Scales (VAS):'}, {'measure': 'Evaluate the effect of proprioceptive exercises on quality of life among geriatric patients with knee osteoarthritis', 'timeFrame': '3months', 'description': 'By using 36 - Item Short-Form Health Survey (SF-36).'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Knee Osteoarthritis']}, 'descriptionModule': {'briefSummary': "Knee osteoarthritis, the disease of knee joint pain caused by joint degeneration, it is the commonest joint disease and had a negative effect on geriatric patients' quality of life (QoL). Proprioceptive exercise and isometric exercise have been recommended as suitable for reducing joint pain and improvement of quality of life in the geriatric patients.", 'detailedDescription': 'Knee osteoarthritis (OA), known as degenerative joint disease of the knee. It is most common in the geriatric and is typically the result of wear and tear and progressive loss of articular cartilage. It happens when cartilage in knee joint breaks down. When this happens, the bones in knee joint rub together, causing friction that makes knees hurt, become stiff or swell. Knee OA is a painful condition and causes exhaustion in affected patients. Patients with this illness often complain of pain, decreased muscle strength, and joint instability. In addition, increased pain in knee OA patients also progressively worsen their quality-of-life. Proprioceptive activity in patients with knee OA gets limited or reduced and leads to reduced activities of daily living (ADLs). Joint proprioception is the ability of an individual to sense the joint position and movement. It encompasses the joint motion and joint position so proprioceptive exercises are being used for the strengthening of muscles around the knee joint. Thus, proprioceptive exercises are recommended exercise which significantly improved pain in knee OA patients which as results lead to improve quality of life. Quadriceps strengthening has been an important component of exercise program of knee osteoarthritis. This is because quadriceps weakness is the most presented finding among people with knee osteoarthritis. An isometric exercise is a form of exercise involving the static contraction of a muscle without any visible movement in the angle of the joint which lead to reduce joint pain and improving QoL in geriatric patients with knee osteoarthritis. The study sample (70) geriatric patients received proprioceptive exercises only, while the control group (70) geriatric patients received routine exercise (Isometric exercise) only.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '60 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria:\n\n* Geriatric patients aged 60 years and above diagnosed with knee OA.\n* Male and female geriatric patients.\n* Alert and able to communicate.\n* Mild and moderate knee OA (based on X-rays)\n\nExclusion criteria:\n\n* Patients with advanced knee OA.\n* Patients with end stage organ failure.\n* Patients with cognitive impairment who will not be able to take active part in the study.\n* Patients with neurological impairment or physical disability that interfere with their participation in the study.\n* Patients with uncontrolled medical conditions.'}, 'identificationModule': {'nctId': 'NCT06574334', 'briefTitle': 'Proprioceptive Exercises on Joint Pain and QoL Among Geriatric Patients With Knee Osteoarthritis', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'Effect of Proprioceptive Exercises on Joint Pain and Quality of Life Among Geriatric Patients With Knee Osteoarthritis', 'orgStudyIdInfo': {'id': 'KOA Geriatric'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'The study group received proprioceptive exercises', 'description': '\\- The study group included education about definition, components and benefits of proprioceptive exercises for geriatric patients with knee osteoarthritis in the first week. Also, was including proprioceptive exercises that included; One-leg balance, Toe walking, Heel walking, Cross-body leg swings, Blind advanced one leg balance and instructed them to do these 5 exercises (15-20 repetitions of each) per session, 5 day a week.', 'interventionNames': ['Procedure: Proprioceptive exercise']}, {'type': 'EXPERIMENTAL', 'label': 'the control group received routine exercise (Isometric exercise).', 'description': 'the control group included education about definition, benefits and steps of isometric exercise that included participants taking the long sitting position. A role of towel was placed below the affected knee. The participants were then asked to press the towel down and hold it to one minute and then relax. This was repeated again for the other knee and (10-15 repetitions) per session, 5 day a week.', 'interventionNames': ['Procedure: Proprioceptive exercise']}], 'interventions': [{'name': 'Proprioceptive exercise', 'type': 'PROCEDURE', 'description': '* The first session was included an orientation to the exercises and its purpose to geriatric participants in the first week. Also, pretest was done in the first session before implementing exercises to assess geriatric KOA pain and QOL, each session started by revision about what was given during the previous session and the objectives of the next session.\n* The 2nd session about exercises.\n* The 3rd session for repetition of exercises to ensure that the patient has learned it well in the second week.\n* The 4th session after six weeks later (from wk. (3) to wk. (8) to make posttest after implementation session.\n* The 5th session after two-month later (from wk. (9) to wk. (16) to do follow up test.', 'armGroupLabels': ['The study group received proprioceptive exercises', 'the control group received routine exercise (Isometric exercise).']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Asyut', 'country': 'Egypt', 'facility': 'Faculty of Nursing', 'geoPoint': {'lat': 27.18096, 'lon': 31.18368}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assiut University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principle investigator', 'investigatorFullName': 'Aml Hamdi Mahmoud', 'investigatorAffiliation': 'Assiut University'}}}}