Ignite Creation Date:
2025-12-24 @ 1:13 PM
Ignite Modification Date:
2026-01-03 @ 3:01 AM
Study NCT ID:
NCT06822595
Status:
COMPLETED
Last Update Posted:
2025-02-12
First Post:
2025-02-02
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
High-Load Blood Flow Restriction (BFR) Training May Decrease Anaerobic Fatigue in Distance Runners
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, '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': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 42}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-07-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2024-07-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-02-06', 'studyFirstSubmitDate': '2025-02-02', 'studyFirstSubmitQcDate': '2025-02-06', 'lastUpdatePostDateStruct': {'date': '2025-02-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-02-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-05-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The effects of an isokinetic training program combined with blood flow restriction (BFR) on anaerobic performance and fatigue resistance in long-distance runners were investigated.', 'timeFrame': 'baseline and week 8', 'description': 'Lower extremity Wingate Test (WanT) was used to evaluate the anaerobic capacities of long-distance runners. In calculating the fatigue index; (peak power - minimum power/peak power) x 100 (% fatigue index) formula was used.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Athlete', 'muscular', 'KAATSU', 'sports medicine', 'performance'], 'conditions': ['Anaerobic Performance']}, 'descriptionModule': {'briefSummary': 'This study investigates the effects of high-load BFR training on anaerobic performance and fatigue resistance in distance runners. To determine whether adding BFR to isokinetic resistance training improves anaerobic performance and 5-10 km running times in runners. Forty-two runners were randomized into BFR (n=21) and control (n=21) groups. Both groups followed an identical 8-week isokinetic training protocol twice weekly. The BFR group performed exercises with arterial occlusion pressure set to 80% of the measured occlusion pressure. Anaerobic performance was assessed via the Wingate test, and 5 km and 10 km running times were recorded before and after the intervention. Statistical analyses compared pre- and post-training performance within and between groups.', 'detailedDescription': 'Blood flow restriction (BFR) training is increasingly used to enhance athletic performance, but its effects on anaerobic fatigue in distance runners remain unclear. This study investigates the effects of high-load BFR training on anaerobic performance and fatigue resistance in distance runners.To determine whether adding BFR to isokinetic resistance training improves anaerobic performance and 5-10 km running times in runners.\n\nForty-two runners were randomized into BFR (n=21) and control (n=21) groups. Both groups followed an identical 8-week isokinetic training protocol twice weekly. The BFR group performed exercises with arterial occlusion pressure set to 80% of the measured occlusion pressure. Anaerobic performance was assessed via the Wingate test, and 5 km and 10 km running times were recorded before and after the intervention. Statistical analyses compared pre- and post-training performance within and between groups.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '35 Years', 'minimumAge': '22 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* The absence of cardiovascular or musculoskeletal conditions,\n* No recent resistance training,\n* Running more than 20 kilometers per week.\n\nExclusion Criteria:\n\n* Having a cardiovascular or musculoskeletal condition,\n* Having done recent resistance training,\n* Running less than 20 kilometers per week.'}, 'identificationModule': {'nctId': 'NCT06822595', 'acronym': 'BFR-Training', 'briefTitle': 'High-Load Blood Flow Restriction (BFR) Training May Decrease Anaerobic Fatigue in Distance Runners', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Gulhane Training and Research Hospital'}, 'officialTitle': 'High-Load Blood Flow Restriction (BFR) Training May Decrease Anaerobic Fatigue in Distance Runners: A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'SBU-GTF'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Blood flow restriction (BFR) Group', 'description': 'BFR group followed an identical 8-week isokinetic training protocol twice weekly. The BFR group performed exercises with arterial occlusion pressure set to 80% of the measured occlusion pressure.', 'interventionNames': ['Device: Blood flow restriction (BFR) training', 'Device: Isokinetic training']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control Group', 'description': 'Control group followed an identical 8-week isokinetic training protocol twice weekly.', 'interventionNames': ['Device: Isokinetic training']}], 'interventions': [{'name': 'Blood flow restriction (BFR) training', 'type': 'DEVICE', 'otherNames': ['Isokinetic training'], 'description': 'Both groups followed an identical 8-week isokinetic training protocol twice weekly. The BFR group performed exercises with arterial occlusion pressure set to 80% of the measured occlusion pressure.', 'armGroupLabels': ['Blood flow restriction (BFR) Group']}, {'name': 'Isokinetic training', 'type': 'DEVICE', 'description': 'Both groups followed an identical 8-week isokinetic training protocol twice weekly.', 'armGroupLabels': ['Blood flow restriction (BFR) Group', 'Control Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06018', 'city': 'Ankara', 'country': 'Turkey (Türkiye)', 'facility': 'Hüseyin Günaydın', 'geoPoint': {'lat': 39.91987, 'lon': 32.85427}}, {'zip': '06018', 'city': 'Ankara', 'country': 'Turkey (Türkiye)', 'facility': 'University of Health Sciences, Gulhane Faculty of Medicine', 'geoPoint': {'lat': 39.91987, 'lon': 32.85427}}], 'overallOfficials': [{'name': 'Hüseyin Günaydın', 'role': 'STUDY_CHAIR', 'affiliation': 'University of Health Sciences, Gulhane Faculty of Medicine, Ankara/Türkiye'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Gulhane Training and Research Hospital', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'associate professor', 'investigatorFullName': 'Tuğba Kocahan', 'investigatorAffiliation': 'Gulhane Training and Research Hospital'}}}}