Ignite Creation Date:
2025-12-24 @ 5:28 PM
Ignite Modification Date:
2026-02-21 @ 4:08 AM
Study NCT ID:
NCT06529068
Status:
COMPLETED
Last Update Posted:
2025-06-12
First Post:
2024-07-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cardiovascular Response to Isometric BFR Exercise
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 21}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-12-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2025-05-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-06-11', 'studyFirstSubmitDate': '2024-07-18', 'studyFirstSubmitQcDate': '2024-07-25', 'lastUpdatePostDateStruct': {'date': '2025-06-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-07-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-05-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Systolic blood pressure and diastolic blood pressure', 'timeFrame': '20 minutes', 'description': 'Beat-by-beat (both systolic and diastolic blood pressure) blood pressure before, during, and after exercise'}, {'measure': 'Brachial artery diameter evaluated by an ultrasound machine', 'timeFrame': 'Before and 20 minutes after exercise', 'description': 'Brachial artery diameter will be measured by an ultrasound machine to calculate flow-mediated dilation (FMD)'}, {'measure': 'Heart rate', 'timeFrame': '20 minutes', 'description': 'Monitor heart rate continuously before, during, and after exercise'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Blood Pressure']}, 'referencesModule': {'references': [{'pmid': '5412979', 'type': 'BACKGROUND', 'citation': 'Lind AR. Cardiovascular responses to static exercise. (Isometrics, anyone?). Circulation. 1970 Feb;41(2):173-6. doi: 10.1161/01.cir.41.2.173. No abstract available.'}, {'pmid': '30086274', 'type': 'BACKGROUND', 'citation': 'Domingos E, Polito MD. Blood pressure response between resistance exercise with and without blood flow restriction: A systematic review and meta-analysis. Life Sci. 2018 Sep 15;209:122-131. doi: 10.1016/j.lfs.2018.08.006. Epub 2018 Aug 4.'}, {'pmid': '30208794', 'type': 'BACKGROUND', 'citation': 'Bond CW, Hackney KJ, Brown SL, Noonan BC. Blood Flow Restriction Resistance Exercise as a Rehabilitation Modality Following Orthopaedic Surgery: A Review of Venous Thromboembolism Risk. J Orthop Sports Phys Ther. 2019 Jan;49(1):17-27. doi: 10.2519/jospt.2019.8375. Epub 2018 Sep 12.'}, {'pmid': '37348015', 'type': 'BACKGROUND', 'citation': "Mannozzi J, Al-Hassan MH, Kaur J, Lessanework B, Alvarez A, Massoud L, Aoun K, Spranger M, O'Leary DS. Blood flow restriction training activates the muscle metaboreflex during low-intensity sustained exercise. J Appl Physiol (1985). 2023 Aug 1;135(2):260-270. doi: 10.1152/japplphysiol.00274.2023. Epub 2023 Jun 22."}, {'pmid': '34823439', 'type': 'BACKGROUND', 'citation': 'Song JS, Yamada Y, Wong V, Bell ZW, Spitz RW, Abe T, Loenneke JP. Hypoalgesia following isometric handgrip exercise with and without blood flow restriction is not mediated by discomfort nor changes in systolic blood pressure. J Sports Sci. 2022 Mar;40(5):518-526. doi: 10.1080/02640414.2021.2003569. Epub 2021 Nov 25.'}, {'pmid': '19952840', 'type': 'BACKGROUND', 'citation': 'Renzi CP, Tanaka H, Sugawara J. Effects of leg blood flow restriction during walking on cardiovascular function. Med Sci Sports Exerc. 2010 Apr;42(4):726-32. doi: 10.1249/MSS.0b013e3181bdb454.'}, {'pmid': '33344005', 'type': 'BACKGROUND', 'citation': 'Early KS, Rockhill M, Bryan A, Tyo B, Buuck D, McGinty J. EFFECT OF BLOOD FLOW RESTRICTION TRAINING ON MUSCULAR PERFORMANCE, PAIN AND VASCULAR FUNCTION. Int J Sports Phys Ther. 2020 Dec;15(6):892-900. doi: 10.26603/ijspt20200892.'}, {'pmid': '20019641', 'type': 'BACKGROUND', 'citation': 'Credeur DP, Hollis BC, Welsch MA. Effects of handgrip training with venous restriction on brachial artery vasodilation. Med Sci Sports Exerc. 2010 Jul;42(7):1296-302. doi: 10.1249/MSS.0b013e3181ca7b06.'}, {'pmid': '29864505', 'type': 'BACKGROUND', 'citation': 'Schneider AC, Hughes WE, Ueda K, Bock JM, Casey DP. Reduced blood pressure responsiveness to skeletal muscle metaboreflex activation in older adults following inorganic nitrate supplementation. Nitric Oxide. 2018 Aug 1;78:81-88. doi: 10.1016/j.niox.2018.05.010. Epub 2018 Jun 1.'}]}, 'descriptionModule': {'briefSummary': 'The goal of this interventional study is to evaluate the acute impact of isometric blood flow restriction (BFR) exercise on blood pressure and other cardiovascular functions in healthy young adult volunteers. The main question it aims to answer is:\n\nThe investigators hypothesize that isometric BFR exercise with a wide-rigid cuff would lead to greater blood pressure and other cardiovascular responses and that these cardiovascular responses would be greater under isometric BFR exercise with narrow-elastic bands compared with the control condition (no cuff).\n\nParticipants will perform isometric exercises in 3 laboratory visits with different exercise conditions) no cuff control 2) BFR with wide-rigid cuff 3) BFR with narrow-elastic band.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n\\- Apparently healthy young adults aged between 18 - 40 years old and signed the informed consent.\n\nExclusion Criteria:\n\n* Abnormal clotting times\n* Acid-base imbalance/acidosis\n* Arterial calcification\n* Atherosclerotic vessels\n* Cardiopulmonary conditions\n* Diabetes\n* Dialysis/central venous access\n* General/local infection\n* High intracranial pressure\n* Hip, pelvis, or femur fracture\n* History of venous thromboembolism\n* Hypertension\n* Immobility for greater than 48 hours in the past month\n* Immobilizing cast\n* Implanted medical device\n* Lymphectomies\n* Obesity\n* Open fracture\n* Open or unhealed soft tissue injuries\n* Paralysis\n* Peripheral vascular disease\n* Pregnancy/postpartum\n* Prior revascularization\n* Renal compromise\n* Severe crush injuries\n* Sickle cell trait/anemia\n* Skin grafts\n* Stroke\n* Temporary nerve damage\n* Thrombophilia\n* Tumor/cancer\n* Varicose veins\n* Vascular grafting'}, 'identificationModule': {'nctId': 'NCT06529068', 'briefTitle': 'Cardiovascular Response to Isometric BFR Exercise', 'organization': {'class': 'OTHER', 'fullName': 'University of Texas at Austin'}, 'officialTitle': 'Blood Pressure Responses to Isometric Blood Flow Restriction Exercise', 'orgStudyIdInfo': {'id': 'STUDY00006378'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Isometric exercise without BFR cuff (control)', 'interventionNames': ['Behavioral: Isometric handgrip exercise']}, {'type': 'EXPERIMENTAL', 'label': 'Isometric exercise with narrow-elastic BFR band', 'interventionNames': ['Behavioral: Isometric handgrip exercise with a narrow-elastic band']}, {'type': 'EXPERIMENTAL', 'label': 'Isometric exercise with wide-rigid BFR cuff', 'interventionNames': ['Behavioral: Isometric handgrip exercise with a wide-rigid cuff']}], 'interventions': [{'name': 'Isometric handgrip exercise', 'type': 'BEHAVIORAL', 'description': 'The participants will perform isometric handgrip exercises without blood flow restriction.', 'armGroupLabels': ['Isometric exercise without BFR cuff (control)']}, {'name': 'Isometric handgrip exercise with a narrow-elastic band', 'type': 'BEHAVIORAL', 'description': 'The participants will perform isometric handgrip exercises with blood flow restriction using a narrow-elastic band.', 'armGroupLabels': ['Isometric exercise with narrow-elastic BFR band']}, {'name': 'Isometric handgrip exercise with a wide-rigid cuff', 'type': 'BEHAVIORAL', 'description': 'The participants will perform isometric handgrip exercises with blood flow restriction using a wide-rigid cuff.', 'armGroupLabels': ['Isometric exercise with wide-rigid BFR cuff']}]}, 'contactsLocationsModule': {'locations': [{'zip': '78712-1415', 'city': 'Austin', 'state': 'Texas', 'country': 'United States', 'facility': 'Cardiovascular Aging Research Laboratory', 'geoPoint': {'lat': 30.26715, 'lon': -97.74306}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Texas at Austin', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}