Ignite Creation Date:
2025-12-25 @ 12:40 AM
Ignite Modification Date:
2025-12-26 @ 1:45 PM
Study NCT ID:
NCT04697667
Status:
COMPLETED
Last Update Posted:
2022-02-15
First Post:
2021-01-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Exercise and PRP vs Exercise Alone in 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': 'D015444', 'term': 'Exercise'}], 'ancestors': [{'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': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Double'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 84}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-01-31', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-02', 'completionDateStruct': {'date': '2022-02-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-02-11', 'studyFirstSubmitDate': '2021-01-03', 'studyFirstSubmitQcDate': '2021-01-05', 'lastUpdatePostDateStruct': {'date': '2022-02-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-01-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-01-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pain intensity', 'timeFrame': '6th week', 'description': "Pain intensity will be measured using the numerical pain rating scale. Patients are asked to circle the number between 0 and 10 that fits best to their pain intensity. Zero usually represents 'no pain at all' whereas the upper limit represents 'the worst pain ever possible'."}, {'measure': 'Pain intensity', 'timeFrame': '3rd month', 'description': "Pain intensity will be measured using the numerical pain rating scale. Patients are asked to circle the number between 0 and 10 that fits best to their pain intensity. Zero usually represents 'no pain at all' whereas the upper limit represents 'the worst pain ever possible'."}, {'measure': 'Function', 'timeFrame': '6th week', 'description': 'Functional status of the patients will be evaluated by The Western Ontario and McMaster Universities Arthritis (WOMAC) Index. It is a self-administered questionnaire consisting of 24 items divided into 3 subscales (Pain, Stiffness and Physical Function). The test questions are scored on a scale of 0-4, which correspond to: None (0), Mild (1), Moderate (2), Severe (3), and Extreme (4). Higher scores on the WOMAC indicate worse results.'}, {'measure': 'Functional performance - 40m fast-paced walk test', 'timeFrame': '6th week', 'description': 'Functional performance of the patients will be evaluated by 40-meter fast-paced walk test. Participants are asked to walk as quickly but as safely as possible, without running, along a 10-meter walkway for a total distance of 40 meters. Walking speed will be measured in meters/second (m/s).'}, {'measure': 'Functional performance - 10-step stair-climb test', 'timeFrame': '6th week', 'description': 'Functional performance of the patients will be evaluated by 10-step stair-climb test. Patients are instructed to ascend and descend the flight of stairs as quickly as possible but in a safe manner. The time needed is recorded in seconds.'}, {'measure': 'Function', 'timeFrame': '3rd month', 'description': 'Functional status of the patients will be evaluated by The Western Ontario and McMaster Universities Arthritis (WOMAC) Index. It is a self-administered questionnaire consisting of 24 items divided into 3 subscales (Pain, Stiffness and Physical Function). The test questions are scored on a scale of 0-4, which correspond to: None (0), Mild (1), Moderate (2), Severe (3), and Extreme (4). Higher scores on the WOMAC indicate worse results.'}, {'measure': 'Functional performance - 40m fast-paced walk test', 'timeFrame': '3rd month', 'description': 'Functional performance of the patients will be evaluated by 40-meter fast-paced walk test. Participants are asked to walk as quickly but as safely as possible, without running, along a 10-meter walkway for a total distance of 40 meters. Walking speed will be measured in meters/second (m/s).'}, {'measure': 'Functional performance - 10-step stair-climb test', 'timeFrame': '3rd month', 'description': 'Functional performance of the patients will be evaluated by 10-step stair-climb test. Patients are instructed to ascend and descend the flight of stairs as quickly as possible but in a safe manner. The time needed is recorded in seconds.'}], 'secondaryOutcomes': [{'measure': 'Range of motion', 'timeFrame': '6th week', 'description': 'Knee joint ROMs will be measured using a universal goniometer. The process will be repeated three times and the average value will be recorded.'}, {'measure': 'Range of motion', 'timeFrame': '3rd month', 'description': 'Knee joint ROMs will be measured using a universal goniometer. The process will be repeated three times and the average value will be recorded.'}, {'measure': 'Health related quality of life', 'timeFrame': '6th week', 'description': 'Health related quality of life will be measured using SF 12 score that measures eight health domains to assess physical and mental health.'}, {'measure': 'Health related quality of life', 'timeFrame': '3rd month', 'description': 'Health related quality of life will be measured using SF 12 score that measures eight health domains to assess physical and mental health.'}, {'measure': 'Patient Satisfaction', 'timeFrame': '6th week', 'description': 'Patient satisfaction will be assessed by the Global Rating of Change scale.'}, {'measure': 'Patient Satisfaction', 'timeFrame': '3rd month', 'description': 'Patient satisfaction will be assessed by the Global Rating of Change scale.'}]}, 'oversightModule': {'isUsExport': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Knee Osteoarthritis']}, 'descriptionModule': {'briefSummary': 'This study is a prospective randomized controlled study of different treatments for knee osteoarthritis and aims to investigate the efficacy of exercise combined platelet rich plasma (PRP) injection versus only exercise or only PRP treatments.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adults 40-70 years of age,\n* Grade 2-3 according to Kellgren Lawrence osteoarthritis classification,\n* No medication for knee osteoarthritis in the past three months,\n* Subjects who understand and sign the consent form for this study.\n\nExclusion Criteria:\n\n* Patients who have received an invasive procedure, intra-articular application and / or physiotherapy in the target knee within three months,\n* Previous partial or total knee replacement of the target knee,\n* Body mass index \\> 30 kg/m2,\n* Having any cardiovascular diseases, neurological disorders, rheumatic diseases, malignancy or psychiatric diseases,\n* Impaired cognition that impacts the ability to give informed consent,\n* Participation in another clinical trial.'}, 'identificationModule': {'nctId': 'NCT04697667', 'briefTitle': 'Exercise and PRP vs Exercise Alone in Patients With Knee Osteoarthritis', 'organization': {'class': 'OTHER', 'fullName': 'Istanbul University - Cerrahpasa'}, 'officialTitle': 'The Combination of Exercise and PRP vs Exercise Alone in Patients With Knee Osteoarthritis: A Randomized Controlled Clinical Trial', 'orgStudyIdInfo': {'id': 'TDK-2020-35062'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group I', 'description': 'Each subject in this group will receive a combined treatment protocol consisting of three PRP injections to knee joint and supervised exercise program.', 'interventionNames': ['Other: Exercise', 'Biological: PRP']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group II', 'description': 'Each subject in this group will receive a treatment of supervised exercise program.', 'interventionNames': ['Other: Exercise']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group III', 'description': 'Each subject in this group will receive a treatment of three PRP injections to knee joint.', 'interventionNames': ['Biological: PRP']}], 'interventions': [{'name': 'Exercise', 'type': 'OTHER', 'description': 'Supervised exercise program', 'armGroupLabels': ['Group I', 'Group II']}, {'name': 'PRP', 'type': 'BIOLOGICAL', 'description': 'Intra-articular PRP injections to knee joint', 'armGroupLabels': ['Group I', 'Group III']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Istanbul', 'country': 'Turkey (Türkiye)', 'facility': 'Istanbul University-Cerrahpasa', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Istanbul University - Cerrahpasa', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Researcher', 'investigatorFullName': 'Sezen Karaborklu Argut', 'investigatorAffiliation': 'Istanbul University - Cerrahpasa'}}}}