Ignite Creation Date:
2025-12-24 @ 12:47 PM
Ignite Modification Date:
2025-12-28 @ 3:02 PM
Study NCT ID:
NCT04600661
Status:
UNKNOWN
Last Update Posted:
2020-10-23
First Post:
2020-10-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
LOW LOAD RESISTANCE BLOOD FLOW RESTRICTION TRAINING VERSUS NEUROMUSCULAR TRAINING IN 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': 'D000090003', 'term': 'Blood Flow Restriction Therapy'}], '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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Sixty Three patients of both genders with mild to moderate unilateral tibiofemoral OA, with age range from 45-60 years will be randomly assigned to 1 of 3 groups using opaque, sealed envelopes, each containing the name of one of the groups. Each patient will sign an informed consent before starting the study (Appendix III). All patients will be referred by the orthopedic surgeon who will diagnose knee OA based on clinical and radiological examination. The investigator will be blinded'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Sixty Three patients of both genders with mild to moderate unilateral tibiofemoral OA, with age range from 45-60 years will be randomly assigned to 1 of 3 groups control group (Traditional therapy group) (n=21): patients will receive traditional training exercises (high load resistance training) Experimental group I (BFR training group) (n=21): patients will receive LLRT with BFR.\n\nExperimental group II (Neuromuscular training group) (n=21): patients will receive neuromuscular training exercises'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 63}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2021-01-15', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-06', 'completionDateStruct': {'date': '2021-09-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-10-19', 'studyFirstSubmitDate': '2020-10-19', 'studyFirstSubmitQcDate': '2020-10-19', 'lastUpdatePostDateStruct': {'date': '2020-10-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-10-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-06-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Muscle strength', 'timeFrame': '3 months', 'description': 'Hand-Held Dynamometer for measuring muscle strength'}], 'secondaryOutcomes': [{'measure': 'Knee joint function', 'timeFrame': '3 months', 'description': 'Western Ontario and McMaster Universities osteoarthritis index for an Arab population for assessing knee function'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Blood flow restriction training'], 'conditions': ['Osteoarthritis of the Knee']}, 'referencesModule': {'references': [{'pmid': '26971109', 'type': 'BACKGROUND', 'citation': 'Bryk FF, Dos Reis AC, Fingerhut D, Araujo T, Schutzer M, Cury Rde P, Duarte A Jr, Fukuda TY. Exercises with partial vascular occlusion in patients with knee osteoarthritis: a randomized clinical trial. Knee Surg Sports Traumatol Arthrosc. 2016 May;24(5):1580-6. doi: 10.1007/s00167-016-4064-7. Epub 2016 Mar 12.'}]}, 'descriptionModule': {'briefSummary': 'This study will be conducted to compare the effect of BFR with LLRT versus neuromuscular training on quadriceps muscle strength, knee joint function and proprioception accuracy.', 'detailedDescription': 'PURPOSE:\n\nThis study will be conducted to compare the effect of BFR with LLRT versus neuromuscular training on quadriceps muscle strength, knee joint function and proprioception accuracy.\n\nBACKGROUND:\n\nPatients with knee OA may have reduction of tolerance of the high-load programs which is recommended for eliciting strength gains (Messier et al., 2013). Thus, for reducing disease risk and enhancing physical function, there is a need for effectively strengthening the quadriceps muscle while limiting pain and adverse joint loading in people with knee OA (Segal et al., 2015). Blood flow restriction (BFR) with low-load resistance training (LLRT) is an alternative to traditional strength training that can be used in knee OA with minimal adverse joint loading that is normally found in traditional strengthening programs(Pope et al., 2013). It is attained through applying pressure externally with a pneumatic cuff or tourniquet. The applied pressure occludes venous outflow while maintaining arterial inflow with intent to promote blood pooling in the capillary beds of the limb muscles distal to the tourniquet (Slysz et al., 2016). Kubota et al., (2008), showed that BFR can be applied during periods of immobilization to decrease disuse muscle atrophy of limbs. Also it can be combined with exercise which enhances muscular development. Resistance exercise appears to provide great muscular gains when combined with BFR (Slysz et al., 2016).\n\nHYPOTHESES:\n\n1. There will not be a significant difference between traditional training, BFR with LLRT and neuromuscular training on improving quadriceps muscle strength using HHD in patients with unilateral knee OA.\n2. There will not be a significant difference between traditional training, BFR with LLRT and neuromuscular training on improving knee joint function on WOMAC questionnaire in patients with unilateral knee OA.\n3. There will not be a significant difference between traditional training, BFR with LLRT and neuromuscular training on improving knee joint proprioception in patients with unilateral knee OA.\n\nRESEARCH QUESTION:\n\nDoes blood flow restriction with low load resistance training and neuromuscular training have a significant effect over traditional rehabilitation protocol (stretching and strengthening for hip and knee muscles) on quadriceps muscle strength, knee joint function and proprioception accuracy in patients with unilateral knee OA?'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '45 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age range from 45-60 years (Segal et al., 2015).\n* Walk with painful knee OA without assistive devices (Bryk et al., 2016).\n* Mild to moderate unilateral OA grade II-III (K/L) (Bryk et al., 2016).\n* BMI \\< 30 kg/m² (not being classified as obese) (Bryk et al., 2016).\n* Never participated in resistance training in the 3 months prior to their appointment (Jan et al., 2008)\n\nExclusion Criteria:\n\n* Severe knee OA (grade IV according to K/L classification).\n* Bilateral knee OA.\n* Congenital or acquired inflammatory, rheumatic or neurological (systemic or local) diseases involving the knee.\n* Repeated treatment with steroids.\n* Secondary knee OA.\n* Received joint replacement surgery in either Knee or/and hip.\n* Cardiovascular and neuromuscular disorders\n* Diabetic patients\n* Psychiatric disorders.'}, 'identificationModule': {'nctId': 'NCT04600661', 'briefTitle': 'LOW LOAD RESISTANCE BLOOD FLOW RESTRICTION TRAINING VERSUS NEUROMUSCULAR TRAINING IN KNEE OSTEOARTHRITIS', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'LOW LOAD RESISTANCE BLOOD FLOW RESTRICTION TRAINING VERSUS NEUROMUSCULAR TRAINING IN KNEE OSTEOARTHRITIS', 'orgStudyIdInfo': {'id': '012/002777'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'control group (Traditional therapy group)', 'description': 'control group (Traditional therapy group) (n=21): patients will receive traditional training exercises (high load resistance training', 'interventionNames': ['Other: Traditional exercise therapy']}, {'type': 'EXPERIMENTAL', 'label': 'Experimental group I (BFR training group)', 'description': 'Experimental group I (BFR training group) (n=21): patients will receive LLRT with BFR.', 'interventionNames': ['Other: Traditional exercise therapy']}, {'type': 'EXPERIMENTAL', 'label': 'Experimental group II (Neuromuscular training group)', 'description': 'Experimental group II (Neuromuscular training group) (n=21): patients will receive neuromuscular training exercises', 'interventionNames': ['Other: Traditional exercise therapy']}], 'interventions': [{'name': 'Traditional exercise therapy', 'type': 'OTHER', 'otherNames': ['Blood flow restriction training'], 'description': 'Neuromuscular training', 'armGroupLabels': ['Experimental group I (BFR training group)', 'Experimental group II (Neuromuscular training group)', 'control group (Traditional therapy group)']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Mai M Abdelkader', 'role': 'CONTACT', 'email': 'mai.abdelkader@pua.edu.eg', 'phone': '+201094355573'}, {'name': 'Enas Fawzy, Prof', 'role': 'CONTACT', 'email': 'Enas.fawzy@pt.cu.edu.eg', 'phone': '+2 01127867507'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mai Mohamed Abdelkader Abdallah', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Masters', 'investigatorFullName': 'Mai Mohamed Abdelkader Abdallah', 'investigatorAffiliation': 'Cairo University'}}}}