Ignite Creation Date:
2025-12-24 @ 9:23 PM
Ignite Modification Date:
2025-12-25 @ 7:09 PM
Study NCT ID:
NCT04423432
Status:
UNKNOWN
Last Update Posted:
2020-06-09
First Post:
2020-06-05
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effects of Creatine and Glucoseamine/ Chondritin Sulfate Co-Supplementation in Addition to Exercise and Physical Therapy 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': 'D004599', 'term': 'Electric Stimulation Therapy'}, {'id': 'D026201', 'term': 'Musculoskeletal Manipulations'}, {'id': 'D003401', 'term': 'Creatine'}], 'ancestors': [{'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D026741', 'term': 'Physical Therapy Modalities'}, {'id': 'D012046', 'term': 'Rehabilitation'}, {'id': 'D000529', 'term': 'Complementary Therapies'}, {'id': 'D006146', 'term': 'Guanidines'}, {'id': 'D000578', 'term': 'Amidines'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000596', 'term': 'Amino Acids'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 36}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-06', 'completionDateStruct': {'date': '2020-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-06-08', 'studyFirstSubmitDate': '2020-06-05', 'studyFirstSubmitQcDate': '2020-06-08', 'lastUpdatePostDateStruct': {'date': '2020-06-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-06-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Knee Pain: Numeric Pain Rating Scale', 'timeFrame': '4 weeks', 'description': 'Knee Pain will be quantified by using Numeric Pain Rating Scale'}, {'measure': 'Knee Range of Motion', 'timeFrame': '4 weeks', 'description': 'Knee Range of Motion will be quantified by using Gonimeter'}, {'measure': 'Knee Isometric Muscle Strength', 'timeFrame': '4 weeks', 'description': 'Knee Isometric Muscle Strength will be quantified by using Modified Sphygmomanometer Dynamometer'}, {'measure': 'Six Minute Walk Test', 'timeFrame': '4 weeks', 'description': 'Six Minute Walk Test will be used to quantify walking related performance fatigability, walkind distance and walking speed.'}], 'secondaryOutcomes': [{'measure': 'Knee Injury and Osteoarthritis Outcome Score (KOOS)', 'timeFrame': '4 weeks', 'description': 'The KOOS is self-administered and assesses five outcomes: pain, symptoms, activities of daily living, sport and recreation function, and knee-related quality of life.'}, {'measure': 'Body Composition', 'timeFrame': '4 weeks', 'description': 'Body Composition will be quantified by using Bioelectrical Impedance'}, {'measure': 'Fall Risk', 'timeFrame': '4 weeks', 'description': 'Fall risk will be quantified by using Biodex balance System'}, {'measure': 'Postural Stability', 'timeFrame': '4 weeks', 'description': 'Postural Stability will be quantified by using Biodex balance System'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Knee Osteoarthritis']}, 'descriptionModule': {'briefSummary': 'Osteoarthritis is the 11th highest contributor to disability world wide. In terms of conservative management of patients with knee osteoarthritis, Resistance exercise has been shown to be an effective intervention for reducing pain and cartilage degeneration and improving muscle strength, joint biomechanics and physical functioning. But, research shows that co supplementation can further augment the effects of resistance exercise. However, it is imperative to point out that the existing evidence is majorly focused on the individual effects of resistance exercise training and non-pharmacological supplementation, and is still deficient in the effects of co-supplementation in addition to resistance exercise training in patients with knee osteoarthritis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 40-70 years\n* Knee OA with history not less than three months.\n* Radiological evidences of grade III or less on Kellgren classification.\n* Knee pain on VNRS no more than 8/10\n\nExclusion Criteria:\n\n* Neuromuscular conditions that may lead to fatigue such as multiple Sclerosis\n* Signs of serious pathology (e.g., malignancy, inflammatory disorder, infection).\n* History of trauma or fractures in lower extremity.\n* Signs of lumbar radiculopathy or myelopathy.\n* History of knee surgery or replacement.\n* Patients on intra-articular steroid therapy within two months before the commencement of the study.\n* Impaired skin sensation.\n* Impaired renal function'}, 'identificationModule': {'nctId': 'NCT04423432', 'briefTitle': 'Effects of Creatine and Glucoseamine/ Chondritin Sulfate Co-Supplementation in Addition to Exercise and Physical Therapy in Patients With Knee Osteoarthritis', 'organization': {'class': 'OTHER', 'fullName': 'Foundation University Islamabad'}, 'officialTitle': 'Effects of Creatine and Glucoseamine/ Chondritin Sulfate Co-Supplementation in Addition to Exercise and Physical Therapy in Patients With Knee Osteoarthritis', 'orgStudyIdInfo': {'id': 'FUI/CTR/2020/4'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Control', 'interventionNames': ['Other: Lower Extremity Resistance Exercise Training', 'Other: Home Exercise Plan', 'Device: Electrotherapy + Heating', 'Procedure: Joint Mobilization']}, {'type': 'EXPERIMENTAL', 'label': 'Creatine Supplementation', 'interventionNames': ['Other: Lower Extremity Resistance Exercise Training', 'Other: Home Exercise Plan', 'Device: Electrotherapy + Heating', 'Procedure: Joint Mobilization', 'Dietary Supplement: Creatine Supplementation']}, {'type': 'EXPERIMENTAL', 'label': 'Glucoseamine/ Chondritin Sulfate Supplementation', 'interventionNames': ['Other: Lower Extremity Resistance Exercise Training', 'Other: Home Exercise Plan', 'Device: Electrotherapy + Heating', 'Procedure: Joint Mobilization', 'Dietary Supplement: Glucoseamine/ Chondritin Sulfate Supplementation']}], 'interventions': [{'name': 'Lower Extremity Resistance Exercise Training', 'type': 'OTHER', 'otherNames': ['Lower Extremity Strength Training'], 'description': '3 times supervised exercise for 4 weeks Warm up (Self Paced walking for 10 minutes) leg press (8-12 RM) leg extension (8-12 RM) Sit to stand squat (with weight) Stationary Cycling (Maximum Resistance as per patient tolerance till failure)', 'armGroupLabels': ['Control', 'Creatine Supplementation', 'Glucoseamine/ Chondritin Sulfate Supplementation']}, {'name': 'Home Exercise Plan', 'type': 'OTHER', 'description': '2 sets of 10 repetitions/day of\n\n1. AROM isolated knee extension and knee flexion\n2. Isometric isolated knee extension and knee flexion\n3. Isometric terminal knee extension\n4. Sit to stand squat\n\nterminal extension as Home Exercise Program (HEP). (Iwamoto J et al, 2007)', 'armGroupLabels': ['Control', 'Creatine Supplementation', 'Glucoseamine/ Chondritin Sulfate Supplementation']}, {'name': 'Electrotherapy + Heating', 'type': 'DEVICE', 'description': 'Iinterferential Current therapy (2P), in combination with heating pad for 20 minutes', 'armGroupLabels': ['Control', 'Creatine Supplementation', 'Glucoseamine/ Chondritin Sulfate Supplementation']}, {'name': 'Joint Mobilization', 'type': 'PROCEDURE', 'otherNames': ['Manual Therapy'], 'description': '1. Tibio-femoral Anterior Glide\n2. Tibio-femoral Posterior Glide\n3. Patellofemoral Joint Mobilization', 'armGroupLabels': ['Control', 'Creatine Supplementation', 'Glucoseamine/ Chondritin Sulfate Supplementation']}, {'name': 'Creatine Supplementation', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['Creatine Monohydrate'], 'description': 'Creatine Supplementation 20g/day for 1 week followed by 5 g/day for 3 weeks', 'armGroupLabels': ['Creatine Supplementation']}, {'name': 'Glucoseamine/ Chondritin Sulfate Supplementation', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Glucoseamine/ Chondritin Sulfate Supplementation (500mg+400mg/day)', 'armGroupLabels': ['Glucoseamine/ Chondritin Sulfate Supplementation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '45710', 'city': 'Islamabad', 'state': 'Federal', 'status': 'RECRUITING', 'country': 'Pakistan', 'contacts': [{'name': 'Muhammad Osama', 'role': 'CONTACT', 'email': 'osamadpt@gmail.com', 'phone': '03325540436'}, {'name': 'Muhammad Osama, PhD*', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Foundation University Institute of Rehabilitation Sciences', 'geoPoint': {'lat': 33.72148, 'lon': 73.04329}}], 'centralContacts': [{'name': 'Muhammad Osama, PhD*', 'role': 'CONTACT', 'email': 'osamadpt@gmail.com', 'phone': '+923325540436'}], 'overallOfficials': [{'name': 'Muhammad Osama, PhD*', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Foundation University Institute of Rehabilitation Sciences'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Foundation University Islamabad', 'class': 'OTHER'}, 'collaborators': [{'name': 'Isra University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}