Ignite Creation Date:
2025-12-24 @ 4:59 PM
Ignite Modification Date:
2025-12-28 @ 7:17 AM
Study NCT ID:
NCT06993350
Status:
COMPLETED
Last Update Posted:
2025-07-28
First Post:
2025-05-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Impact of a Targeted 8-Week Exercise Program on Pain Measures and Isokinetic Muscle Strength in Females With Patellofemoral Pain Syndrome
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D046788', 'term': 'Patellofemoral Pain Syndrome'}], 'ancestors': [{'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D055070', 'term': 'Resistance Training'}], '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': 'D064797', 'term': 'Physical Conditioning, Human'}, {'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': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2025-03-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2025-04-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-07-23', 'studyFirstSubmitDate': '2025-05-19', 'studyFirstSubmitQcDate': '2025-05-27', 'lastUpdatePostDateStruct': {'date': '2025-07-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-05-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-04-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'pain intensity', 'timeFrame': 'two times of testing (before and 8 weeks after intervention)', 'description': 'measured by Visual Analogue Scale. a score range from 0 to 10. 0 means no pain and 10 means severe pain'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Patellofemoral pain syndrome', 'weight-bearing pain', 'isokinetic strength'], 'conditions': ['Patellofemoral Pain Syndrome']}, 'descriptionModule': {'briefSummary': 'Patellofemoral pain syndrome (PFPS) is condition characterized by anterior knee pain that predominantly affects young and physically active females. The etiology of PFPS is multifactorial, involving biomechanical, muscular, and neuromuscular factors that contribute to altered patellar tracking and increased pain sensitivity.', 'detailedDescription': 'This study will employ a randomized controlled trial (RCT) design to evaluate the effects of a targeted 8-week exercise program on pain measures and isokinetic muscle strength in females with PFPS. Thirty female patients diagnosed with PFPS will be recruited based on predefined inclusion and exclusion criteria. Participants will be randomly assigned into two groups: an intervention group receiving the targeted exercise program, and a control group will not receive any intervention.The intervention group will undergo a supervised, structured exercise program lasting 8 weeks, focusing on strengthening the hip and knee muscles, improving neuromuscular control, and addressing pain sensitivity. Sessions will be conducted multiple times per week under professional supervision. Outcome measures will include pain measures, assessed through validated tools such as pressure pain threshold and pain intensity measured by VAS scale and isokinetic muscle strength of knee and hip muscles, measured by isokinetic dynamometry at the Biodex isokinetic Laboratory at the Faculty of Physical Therapy, Cairo University.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nEligible participants will present with clinically diagnosed anterior knee pain exacerbated by activities such as stair climbing, squatting, or prolonged sitting, with a pain duration of at least three months to ensure chronicity. All participants will possess adequate intellectual and cognitive abilities to comprehend and follow exercise instructions, and they will provide informed consent prior to enrollment.\n\nExclusion Criteria:\n\nExclusion criteria will include any history of knee surgery or trauma within the past year, presence of other knee pathologies such as ligament injuries or osteoarthritis, neurological or systemic disorders affecting lower limb function, pregnancy, contraindications to exercise, or current involvement in other physical therapy or structured exercise programs targeting the knee.'}, 'identificationModule': {'nctId': 'NCT06993350', 'briefTitle': 'Impact of a Targeted 8-Week Exercise Program on Pain Measures and Isokinetic Muscle Strength in Females With Patellofemoral Pain Syndrome', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Impact of a Targeted 8-Week Exercise Program on Pain Measures and Isokinetic Muscle Strength in Females With Patellofemoral Pain Syndrome: A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'Faculty of Physical Therapy'}, 'secondaryIdInfos': [{'id': 'faculty of physical therapy', 'type': 'REGISTRY', 'domain': 'faculty of physical therapy'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'group A (patients with PFPS)', 'description': 'patients receive specific weight bearing program known as weight bearing exercise for better balance program', 'interventionNames': ['Other: experimental group']}, {'type': 'NO_INTERVENTION', 'label': 'control group', 'description': 'patient will not receive any intervention'}], 'interventions': [{'name': 'experimental group', 'type': 'OTHER', 'otherNames': ['weight bearing program'], 'description': 'eight weeks of targeted weight bearing program', 'armGroupLabels': ['group A (patients with PFPS)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '12511', 'city': 'Giza', 'country': 'Egypt', 'facility': 'Faculty of Physical Therapy, Cairo University', 'geoPoint': {'lat': 30.00944, 'lon': 31.20861}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Prof. Dr', 'investigatorFullName': 'Azza Mohammed', 'investigatorAffiliation': 'Cairo University'}}}}