protocolSection identificationModule nctId: NCT06334224, orgStudyIdInfo id: 2242/MODREC/23, briefTitle: Acute Physiological Responses to Twice Daily Blood Flow Restriction Training, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-11-06, primaryCompletionDateStruct date: 2024-09, completionDateStruct date: 2024-09, studyFirstPostDateStruct date: 2024-03-27, lastUpdatePostDateStruct date: 2024-03-27, sponsorCollaboratorsModule leadSponsor name: Defence Medical Rehabilitation Centre, UK, class: OTHER_GOV, collaborators name: University of Bath, descriptionModule briefSummary: The Academic Department of Military Rehabilitation (ADMR) is currently conducting a pan-defence, randomised control trial (RCT) investigating the utility of twice daily blood flow restriction training in UK military personnel with persistent knee pain (NCT05719922). Due to logistical confinements, this pan-defence RCT is confined to collecting outcome data pre and post-intervention. Therefore, the acute physiological mechanisms which underpin adaptation will remain unknown.Consequently, ADMR is undertaking an additional, single centre RCT which will compare the acute physiological responses to low load resistance training with and without the addition of blood flow restriction. Specifically, this study will elucidate the effect of twice daily blood flow restriction training on measures of muscle swelling, muscle damage and inflammation. This data may aid in the optimisation of blood flow restriction exercise prescription within UK Defence Rehabilitation and elsewhere., conditionsModule conditions: Muscle Weakness, conditions: Muscle Damage, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Two arm randomised control trial, primaryPurpose: BASIC_SCIENCE, maskingInfo masking: NONE, maskingDescription: Due to the nature of the intervention, it is not possible to blind participants or outcome assessors to the treatment allocation. There is also no effective sham condition available. This is a common limitation within all blood flow restriction training research., enrollmentInfo count: 18, type: ESTIMATED, armsInterventionsModule interventions name: Low load resistance training with blood flow restriction, interventions name: Low load resistance training, outcomesModule primaryOutcomes measure: Maximum isometric voluntary contraction of knee extensor muscles, secondaryOutcomes measure: Vastus lateralis muscle thickness, secondaryOutcomes measure: Venous blood sampling for markers of exercise induced muscle damage, secondaryOutcomes measure: Delayed onset muscle soreness, secondaryOutcomes measure: Quadriceps discomfort, secondaryOutcomes measure: Discomfort caused by the BFR cuff, secondaryOutcomes measure: Rating of perceived exertion, secondaryOutcomes measure: Knee joint range of motion, secondaryOutcomes measure: Daily wellness questionnaire, secondaryOutcomes measure: Venous blood sampling for inflammatory markers, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 55 Years, stdAges: ADULT, contactsLocationsModule locations facility: Defence Medical Rehabilitation Centre, status: RECRUITING, city: Loughborough, zip: LE12 5QW, country: United Kingdom, contacts name: Kieran M Lunt, MSc, role: CONTACT, phone: +44(0) 1509 251 500, phoneExt: 3401, email: kieran.lunt103@mod.gov.uk, contacts name: Peter Ladlow, PhD, role: CONTACT, phone: +44(0) 1509 251 500, phoneExt: 3407, email: peter.ladlow100@mod.gov.uk, contacts name: Kieran M Lunt, MSc, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 52.76667, lon: -1.2, hasResults: False