Ignite Creation Date:
2025-12-24 @ 3:50 PM
Ignite Modification Date:
2025-12-28 @ 5:34 AM
Study NCT ID:
NCT04865692
Status:
COMPLETED
Last Update Posted:
2021-04-29
First Post:
2021-04-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Low Intensity Blood Flow Restriction on Clinical Outcomes in Women 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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-02-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-04', 'completionDateStruct': {'date': '2020-09-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-04-26', 'studyFirstSubmitDate': '2021-04-26', 'studyFirstSubmitQcDate': '2021-04-26', 'lastUpdatePostDateStruct': {'date': '2021-04-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-04-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-02-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Quadriceps muscle strength', 'timeFrame': '12 Weeks', 'description': 'dynamometer was used to assess strength'}, {'measure': 'thigh muscle size', 'timeFrame': '12 weeks', 'description': 'measuring tape was used to measure'}, {'measure': 'Pain', 'timeFrame': '12 weeks', 'description': 'pain was measured through NPRS'}], 'secondaryOutcomes': [{'measure': 'Activities of daily living', 'timeFrame': '12 weeks'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Osteoarthritis, Knee']}, 'descriptionModule': {'briefSummary': 'Objective is to compare the effects of routine physical therapy with and without low intensity blood flow restriction on pain and quadriceps muscle strength in women with knee osteoarthritis.\n\nA single blinded randomized controlled trial conducted at Department of Physiotherapy, University of Lahore Teaching Hospital, Defense Road, Lahore.\n\nTotal 60 participants were randomly assigned in to two groups, with 30 in each group The intervention group received routine physiotherapy program combined with Low Intensity Blood Flow Restriction Technique (LI-BFR. While control group were treated with only routine physiotherapy.\n\nDynamometer was used to assess the knee extensor strength while Knee injury and osteoarthritis outcome score was used to record any exacerbation in pain and effects of BFR on activities of daily living. Training load determined 20% of 1RM. Data analysis had done on SPSS version 23.', 'detailedDescription': 'nonparametric test Friedman test was for comparison within the groups and Mann Whitney U test was used for comparison between groups.\n\nRandomization had done through the sealed envelope method. After allocation subjects had received their treatment protocals.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '45 Years', 'genderBased': True, 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Diagnosed patients of grade II knee osteoarthritis\n* Patient's age 45-65\n\nExclusion Criteria:\n\n* Bilateral knee replacement\n* Lower limb surgery in the last six months\n* Diagnosis of inflammatory joint or muscle disease\n* Chest pain during exercise or at rest; or need for supplemental oxygen\n* Pregnancy\n* Any systemic disease"}, 'identificationModule': {'nctId': 'NCT04865692', 'acronym': 'BFR', 'briefTitle': 'Effects of Low Intensity Blood Flow Restriction on Clinical Outcomes in Women With Knee Osteoarthritis', 'organization': {'class': 'OTHER', 'fullName': 'University of Lahore'}, 'officialTitle': 'Effects of Blood Flow Restriction on Clinical Outcomes in Women With Knee Osteoarthritis', 'orgStudyIdInfo': {'id': '719-II'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Interventional group', 'description': 'The interventional group received resisted knee extension 20% of 1RM with blood flow restriction along with routine physical therapy.', 'interventionNames': ['Other: BFRT', 'Other: Routine Physical Therapy']}, {'type': 'OTHER', 'label': 'Control Group', 'description': 'The Control group received routine physical therapy alone including knee isometrics and resisted knee extension', 'interventionNames': ['Other: Routine Physical Therapy']}], 'interventions': [{'name': 'BFRT', 'type': 'OTHER', 'description': "Patients of Interventional group were treated with routine physiotherapy program combined with LI-BFR consist of 10 minutes' session 3 per week for 12 weeks. In order to determine the training load 20% of 1RM, participants had performed knee extension in full range with a challenging weight. After each test, participants rated their perceived exertion level on (RPE) scale to determine the difficulty of the resistance. The derived 1RM was used to determine the 20% 1RM load used for low-load training. Blood flow restriction proximal to the working muscles achieved through using pressure cuffs. The cuff was applied to the proximal thigh. During week 1 the inflation pressure was 100mmHg. Final exercise pressure based the week of the training. Quadriceps size was measured by tape measures thigh", 'armGroupLabels': ['Interventional group']}, {'name': 'Routine Physical Therapy', 'type': 'OTHER', 'description': 'knee isometrics, resisted knee extension with chalanging weight 2 sets of 10 Reps with 5 sec hold', 'armGroupLabels': ['Control Group', 'Interventional group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '54000', 'city': 'Lahore', 'state': 'Punjab Province', 'country': 'Pakistan', 'facility': 'University of Lahore Teaching Hospital', 'geoPoint': {'lat': 31.558, 'lon': 74.35071}}], 'overallOfficials': [{'name': 'zoya Mujahid, DPT', 'role': 'STUDY_CHAIR', 'affiliation': 'University of Lahore'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Lahore', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}