Ignite Creation Date:
2025-12-25 @ 12:03 AM
Ignite Modification Date:
2025-12-25 @ 10:02 PM
Study NCT ID:
NCT06656858
Status:
COMPLETED
Last Update Posted:
2024-10-24
First Post:
2024-02-19
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Acute Effects of Static and PNF Stretching Exercise With Blood Flow Restriction in Athletes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D052580', 'term': 'Muscle Stretching Exercises'}], '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': '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': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 109}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-08-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'completionDateStruct': {'date': '2023-08-25', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-10-22', 'studyFirstSubmitDate': '2024-02-19', 'studyFirstSubmitQcDate': '2024-10-22', 'lastUpdatePostDateStruct': {'date': '2024-10-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-10-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-08-25', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'hamstring flexibility', 'timeFrame': 'immediately after intervention', 'description': 'Passive straight leg rise test for dominant leg'}], 'secondaryOutcomes': [{'measure': 'Power', 'timeFrame': 'immediately after intervention', 'description': 'single leg hop distance for dominant and non-dominant leg'}, {'measure': 'muscle strength', 'timeFrame': 'immediately after intervention', 'description': 'isometric and eccentric hamstring muscle strength of the dominant leg'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['blood flow restriction, stretching, flexibility, hamstring'], 'conditions': ['Athletes']}, 'descriptionModule': {'briefSummary': 'The study aims to examine the acute effects of static and proprioceptive neuromuscular facilitation stretching exercises with blood flow restriction on hamstring flexibility, muscle strength, and single leg hop in athletes. Outcome measures were hip range of motion, isometric and eccentric hamstring muscle strength, and single leg hop distance.', 'detailedDescription': 'A total of 109 athletes were included in the study. Participants were randomized into five groups: (1) static stretching, (2) proprioceptive neuromuscular facilitation (PNF) stretching, (3) blood flow restriction (BFR) + static stretching, (4) BFR + PNF stretching, and (5) control groups. Stretching exercises were performed on the dominant leg hamstring muscle group for 3 sets of 15 seconds each. BFR was applied during the stretching to the blood flow restriction (BFR) + static stretching and BFR + PNF stretching groups. No stretching was applied to the control group.\n\nAssessments were performed at baseline and immediately after stretching. Hamstring flexibility (hip joint range of motion) was assessed via the passive straight leg raise test. Isometric and eccentric hamstring muscle strength were measured using a hand-held dynamometer, and muscle power was assessed using the single leg hop distance.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age between 18-40 years old\n* Engaged in regular physical activity for at least 8 hours a week for the last 6 months\n* Body mass index (BMI) \\< than 30 kg/m²\n* Momentary blood pressure less than 135/85 mmHg\n\nExclusion Criteria:\n\n* History of fractures or surgical operations involving the lower limbs, hips, or lumbar region\n* history of fractures, surgeries and other diagnosed medical conditions on the lower extremity, hip, and lumbar region\n* Systemic musculoskeletal disease\n* Pain in the lower back, hips, or lower extremities\n* Known hip deformity or diagnosis of scoliosis\n* History of deep vein thrombosis or embolism\n* Diagnosis of circulatory system diseases such as hypertension or peripheral vascular disease\n* History of anemia\n* Previous cerebrovascular disease or myocardial infarction.'}, 'identificationModule': {'nctId': 'NCT06656858', 'briefTitle': 'The Acute Effects of Static and PNF Stretching Exercise With Blood Flow Restriction in Athletes', 'organization': {'class': 'OTHER', 'fullName': 'Dokuz Eylul University'}, 'officialTitle': 'The Acute Effects of Static and PNF Stretching Exercise With Blood Flow Restriction on Hamstring Flexibility, Muscle Strength and Single Leg Hop in Athletes : A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': '5016-GOA'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Static stretching', 'description': "Static stretching exercises were performed on the dominant leg's hamstring muscle group for 3 sets of 15 seconds.", 'interventionNames': ['Other: Static stretching']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'PNF stretching', 'description': "PNF stretching exercises were performed on the dominant leg's hamstring muscle group for 3 sets of 15 seconds.", 'interventionNames': ['Other: PNF stretching']}, {'type': 'EXPERIMENTAL', 'label': 'Static stretching with BFR', 'description': "Static stretching exercises were performed on the dominant leg's hamstring muscle group for 3 sets of 15 seconds with BFR application.", 'interventionNames': ['Other: Static stretching with BFR']}, {'type': 'EXPERIMENTAL', 'label': 'PNF stretching with BFR', 'description': "PNF stretching exercises were performed on the dominant leg's hamstring muscle group for 3 sets of 15 seconds with BFR application", 'interventionNames': ['Other: PNF stretching with BFR']}, {'type': 'OTHER', 'label': 'Control', 'description': 'No stretching was applied to the control group. An information brochure about hamstring injuries was provided to the participants.', 'interventionNames': ['Other: Control']}], 'interventions': [{'name': 'Static stretching', 'type': 'OTHER', 'description': "Static stretching exercises were performed on the dominant leg's hamstring muscle group for 3 sets of 15 seconds", 'armGroupLabels': ['Static stretching']}, {'name': 'PNF stretching', 'type': 'OTHER', 'description': "PNF stretching exercises were performed on the dominant leg's hamstring muscle group for 3 sets of 15 seconds.", 'armGroupLabels': ['PNF stretching']}, {'name': 'Static stretching with BFR', 'type': 'OTHER', 'description': "Static stretching exercises were performed on the dominant leg's hamstring muscle group for 3 sets of 15 seconds with BFR application.", 'armGroupLabels': ['Static stretching with BFR']}, {'name': 'PNF stretching with BFR', 'type': 'OTHER', 'description': "PNF stretching exercises were performed on the dominant leg's hamstring muscle group for 3 sets of 15 seconds with BFR application.", 'armGroupLabels': ['PNF stretching with BFR']}, {'name': 'Control', 'type': 'OTHER', 'description': 'No stretching was applied to the control group. An information brochure about hamstring injuries was provided to the participants.', 'armGroupLabels': ['Control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35330', 'city': 'Izmir', 'state': 'Balcova', 'country': 'Turkey (Türkiye)', 'facility': 'Dokuz Eylul University, Sports Medicine Department', 'geoPoint': {'lat': 38.41273, 'lon': 27.13838}}], 'overallOfficials': [{'name': 'Ayse Birsu Topcugil Kirik, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Dokuz Eylul University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Dokuz Eylul University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Ayşe Birsu Topcugil Kırık', 'investigatorAffiliation': 'Dokuz Eylul University'}}}}