Ignite Creation Date:
2025-12-24 @ 7:40 PM
Ignite Modification Date:
2026-01-01 @ 11:34 AM
Study NCT ID:
NCT05446103
Status:
UNKNOWN
Last Update Posted:
2022-07-06
First Post:
2022-06-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Hypoalgesic Effects of Low Load Blood Flow Restriction Training (BFRT)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009043', 'term': 'Motor Activity'}], 'ancestors': [{'id': 'D001519', 'term': 'Behavior'}]}, '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': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Using sham blood flow restriction (A cuff will be placed on the arm with minimum pressure \\<20% of arterial occlusive pressure)'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2022-07', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-06', 'completionDateStruct': {'date': '2022-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-06-30', 'studyFirstSubmitDate': '2022-06-28', 'studyFirstSubmitQcDate': '2022-06-30', 'lastUpdatePostDateStruct': {'date': '2022-07-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-07-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pressure pain threshold', 'timeFrame': 'Baseline and 30 minutes', 'description': "Changes between pre- and post- intervention in Pressure Pain Threshold will be measured using bilateral sites on quadriceps, upper trapezius, lateral epicondyle and biceps. The COMPACT DIGITAL ALGOMETER CAPACITIES TO: 100 lbf / 50 kgf / 500 N, will be used by an independent assessor. The assessor will be blinded to participants' group."}], 'secondaryOutcomes': [{'measure': 'Rating of perceived exertion', 'timeFrame': 'At the end of the 1st, 2nd, 3rd and 4th set ( after 1, 2, 3 and 4 minutes respectively)', 'description': "Changes between each set of exercise of Perceived Exertion. Measurements will include a Borg 6-20 scale based on the strain and fatigue in muscles. 6 means 'no exertion at all' and 20 means 'maximal"}, {'measure': 'Blood pressure', 'timeFrame': 'Baseline and 30 minutes', 'description': 'Changes in systolic and diastolic blood pressure between pre and post intervention. Blood pressure will be measured in a seated position using a electronic device (Omron)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['blood flow restriction', 'pressure pain threshold', 'exercise', 'training'], 'conditions': ['Healthy']}, 'referencesModule': {'references': [{'pmid': '32423577', 'type': 'BACKGROUND', 'citation': 'Bowman EN, Elshaar R, Milligan H, Jue G, Mohr K, Brown P, Watanabe DM, Limpisvasti O. Upper-extremity blood flow restriction: the proximal, distal, and contralateral effects-a randomized controlled trial. J Shoulder Elbow Surg. 2020 Jun;29(6):1267-1274. doi: 10.1016/j.jse.2020.02.003.'}, {'pmid': '11710658', 'type': 'BACKGROUND', 'citation': 'Gearhart RE, Goss FL, Lagally KM, Jakicic JM, Gallagher J, Robertson RJ. Standardized scaling procedures for rating perceived exertion during resistance exercise. J Strength Cond Res. 2001 Aug;15(3):320-5.'}, {'pmid': '32105522', 'type': 'BACKGROUND', 'citation': 'Hughes L, Patterson SD. The effect of blood flow restriction exercise on exercise-induced hypoalgesia and endogenous opioid and endocannabinoid mechanisms of pain modulation. J Appl Physiol (1985). 2020 Apr 1;128(4):914-924. doi: 10.1152/japplphysiol.00768.2019. Epub 2020 Feb 27.'}, {'pmid': '31288213', 'type': 'BACKGROUND', 'citation': 'Hughes L, Patterson SD, Haddad F, Rosenblatt B, Gissane C, McCarthy D, Clarke T, Ferris G, Dawes J, Paton B. Examination of the comfort and pain experienced with blood flow restriction training during post-surgery rehabilitation of anterior cruciate ligament reconstruction patients: A UK National Health Service trial. Phys Ther Sport. 2019 Sep;39:90-98. doi: 10.1016/j.ptsp.2019.06.014. Epub 2019 Jul 2.'}, {'pmid': '29879638', 'type': 'BACKGROUND', 'citation': 'Korakakis V, Whiteley R, Epameinontidis K. Blood Flow Restriction induces hypoalgesia in recreationally active adult male anterior knee pain patients allowing therapeutic exercise loading. Phys Ther Sport. 2018 Jul;32:235-243. doi: 10.1016/j.ptsp.2018.05.021. Epub 2018 May 31.'}, {'pmid': '30268966', 'type': 'BACKGROUND', 'citation': 'Korakakis V, Whiteley R, Giakas G. Low load resistance training with blood flow restriction decreases anterior knee pain more than resistance training alone. A pilot randomised controlled trial. Phys Ther Sport. 2018 Nov;34:121-128. doi: 10.1016/j.ptsp.2018.09.007. Epub 2018 Sep 19.'}, {'pmid': '28100183', 'type': 'BACKGROUND', 'citation': 'Lacruz ME, Kluttig A, Kuss O, Tiller D, Medenwald D, Nuding S, Greiser KH, Frantz S, Haerting J. Short-term blood pressure variability - variation between arm side, body position and successive measurements: a population-based cohort study. BMC Cardiovasc Disord. 2017 Jan 18;17(1):31. doi: 10.1186/s12872-017-0468-7.'}, {'pmid': '28289561', 'type': 'BACKGROUND', 'citation': 'Calvo Lobo C, Romero Morales C, Rodriguez Sanz D, Sanz Corbalan I, Sanchez Romero EA, Fernandez Carnero J, Lopez Lopez D. Comparison of hand grip strength and upper limb pressure pain threshold between older adults with or without non-specific shoulder pain. PeerJ. 2017 Feb 9;5:e2995. doi: 10.7717/peerj.2995. eCollection 2017.'}, {'pmid': '31710505', 'type': 'BACKGROUND', 'citation': 'Minniti MC, Statkevich AP, Kelly RL, Rigsby VP, Exline MM, Rhon DI, Clewley D. The Safety of Blood Flow Restriction Training as a Therapeutic Intervention for Patients With Musculoskeletal Disorders: A Systematic Review. Am J Sports Med. 2020 Jun;48(7):1773-1785. doi: 10.1177/0363546519882652. Epub 2019 Nov 11.'}, {'pmid': '31156448', 'type': 'BACKGROUND', 'citation': 'Patterson SD, Hughes L, Warmington S, Burr J, Scott BR, Owens J, Abe T, Nielsen JL, Libardi CA, Laurentino G, Neto GR, Brandner C, Martin-Hernandez J, Loenneke J. Blood Flow Restriction Exercise: Considerations of Methodology, Application, and Safety. Front Physiol. 2019 May 15;10:533. doi: 10.3389/fphys.2019.00533. eCollection 2019.'}]}, 'descriptionModule': {'briefSummary': 'A randomized controlled trial comparing the immediate effects of upper limb low-load blood flow restriction training (BFRT) with high load sham-BFRT on hypoalgesia and perceptual response in healthy adults', 'detailedDescription': 'Healthy individuals will be randomized to one of two groups. A target of 40 patients for enrollment has been set for 80% power, p\\<0.05 (Effect size= 1). A single Intervention will be used (40 minutes).\n\nIntervention Group: A single exercise of elbow flexion with Blood Flow Restriction (30-15-15-15 reps) using 30% of 1 Repetition Maximum.\n\nControl Group: A single exercise of elbow flexion with sham Blood Flow Restriction (4x10 reps) using 65% of 1 Repetition Maximum.\n\nPrimary outcome: pressure pain thresholds on quadriceps, biceps, lateral epicondyle and upper trapezius (bilateral).\n\nSecondary outcomes: difference in perceptual response (exertion), change in blood pressure'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* BMI\\< 30\n* able to perform full elbow flexion and extension\n\nExclusion Criteria:\n\n* shoulder tendinopathy,\n* cervical radiculopathy,\n* rheumatoid arthritis,\n* neurological deficit,\n* serious cardiovascular diseases,\n* venous deficiency,\n* history of heart surgery,\n* cancer history,\n* breast surgery,\n* orthopaedic surgeries during the last 6 months,\n* thrombosis,\n* diabetes,\n* body mass Index ≥ 30,\n* Crohn syndrome,\n* family or personal history of pulmonary embolism'}, 'identificationModule': {'nctId': 'NCT05446103', 'acronym': 'BFRT', 'briefTitle': 'The Hypoalgesic Effects of Low Load Blood Flow Restriction Training (BFRT)', 'organization': {'class': 'OTHER', 'fullName': 'University of West Attica'}, 'officialTitle': 'The Acute Effect of Upper Limb Low Load Blood Flow Restriction Training (BFRT) on Hypoalgesia. A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'SK1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'BFR', 'description': '20 healthy individuals will be assigned to perform elbow flexion exercises with low-load resistance BFR training (30% of 1 RM)', 'interventionNames': ['Other: Blood flow restriction training']}, {'type': 'SHAM_COMPARATOR', 'label': 'Sham BFR', 'description': '20 healthy individuals will be assigned to perform elbow flexion exercises with high-load resistance training with sham BFR (65% of 1 RM)', 'interventionNames': ['Other: Sham Blood flow restriction training']}], 'interventions': [{'name': 'Blood flow restriction training', 'type': 'OTHER', 'description': 'After warming up, the load is set at 80% of the predicted 1Repetition Maximum (RM) for elbow flexors. Following each successful repetition, the load is increased by 0.5 to 1kg until patients: fail to execute the exercise through the entire range of motion; used improper form to complete the repetition; needed assistance; reported pain. We will allow a 2-3 min of rest between each attempt to ensure recovery.\n\nThe session starts by calculating the arterial occlusion pressure in the standard anatomical position. Participants rest in the standing position for 3-5 minutes before measurement to ensure restoration of blood flow circulation and a cuff is placed in the most proximal part of their dominant upper-limb. BFR application is conducted by using an automatic personalized tourniquet system (Mad-Up Pro, France). An 40% occlusion pressure is set and subjects perform 4 sets of elbow flexion (30-15-15-15 reps) using 30% of 1 RM', 'armGroupLabels': ['BFR']}, {'name': 'Sham Blood flow restriction training', 'type': 'OTHER', 'description': 'After warming up, the load is set at 80% of the predicted 1Repetition Maximum (RM) for elbow flexors. Following each successful repetition, the load is increased by 0.5 to 1kg until patients: fail to execute the exercise through the entire range of motion; used improper form to complete the repetition; needed assistance; reported pain. We will allow a 2-3 min of rest between each attempt to ensure recovery.\n\nThe session starts by calculating the arterial occlusion pressure in the standard anatomical position. Participants rest in the standing position for 3-5 minutes before measurement to ensure restoration of blood flow circulation and a cuff is placed in the most proximal part of their dominant upper-limb. BFR application is conducted by using an automatic personalized tourniquet system (Mad-Up Pro, France). An \\<20% of occlusion pressure is set and subjects perform 4 sets of 10 reps of elbow flexion using 65% of 1 RM', 'armGroupLabels': ['Sham BFR']}]}, 'contactsLocationsModule': {'locations': [{'zip': '12243', 'city': 'Aigáleo', 'state': 'Attica', 'country': 'Greece', 'contacts': [{'name': 'George Gioftsos, PhD', 'role': 'CONTACT', 'email': 'gioftsos@uniwa.gr', 'phone': '+30 210 538 7485'}], 'facility': 'University of West Attica', 'geoPoint': {'lat': 37.98333, 'lon': 23.68333}}], 'centralContacts': [{'name': 'Stefanos Karanasios, PhD', 'role': 'CONTACT', 'email': 'skaranasios@uniwa.gr', 'phone': '+306947686583'}], 'overallOfficials': [{'name': 'George Gioftsos, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'University of West Attica'}, {'name': 'Stefanos Karanasios, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'University of West Attica'}, {'name': 'Alexia Sozeri, MSc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of West Attica'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of West Attica', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Stefanos Karanasios', 'investigatorAffiliation': 'University of West Attica'}}}}