protocolSection identificationModule nctId: NCT06380179, orgStudyIdInfo id: USUHS.2023-126, briefTitle: Photomedicine Project 14: PBMT for Performance Enhancement in SOF, acronym: SOF, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05, primaryCompletionDateStruct date: 2025-08, completionDateStruct date: 2026-01, studyFirstPostDateStruct date: 2024-04-23, lastUpdatePostDateStruct date: 2024-04-23, sponsorCollaboratorsModule leadSponsor name: Musculoskeletal Injury Rehabilitation Research for Operational Readiness (MIRROR), class: UNKNOWN, collaborators name: Uniformed Services University (USU) of the Health Sciences, collaborators name: 1st Special Forces Group (Airborne), United States Army, collaborators name: United States Army Special Operations Command, collaborators name: The Geneva Foundation, descriptionModule briefSummary: Special Operations Forces (SOF) train continually to maintain peak performance. Thus, they are nearly always in a state of recovery, and in need of noninvasive therapies to address the taxing workload. Photobiomodulation therapy (PBMT) is a noninvasive treatment where a low-level laser is applied to the body to enhance healing, recovery, and performance. Army Tactical Human Optimization Rapid Rehabilitation and Reconditioning (THOR3) provides a consistent avenue for implementation of PBMT as a modality. Studies in athletes have shown performance and recovery benefits with pre-and post-workout focal application of PBMT. While there is less evidence on the potential cognitive/behavioral effects of a systematic application of PBMT, self-reported fatigue has also been found to be significantly lower in groups with focal PBMT application as compared to placebo. Further, PBMT research in healthy military tactical athletes is limited. PBMT may be a promising tool for enhancing physical performance by accelerating musculoskeletal and psychological recovery in the SOF population. The investigators aim to study the physiologic and behavioral effects of PBMT application post-exercise on performance in SOF Operators.The Intent: The investigators propose to conduct a single-blinded randomized-control trial with sham control to investigate the effectiveness of providing PBMT post physical training in a SOF population.The specific aims of this study are to:1. Analyze and describe the physiologic effects, if any, of PBMT application post-exercise in Special Forces Operators undergoing coach-led training.2. Analyze and describe the behavioral effects, if any, of PBMT application post-exercise in Special Forces Operators undergoing coach-led training.3. Evaluate the overall clinical utility of focal PBMT subsequent to physical training in a US Army SOF, tactical athlete population., conditionsModule conditions: Photobiomodulation Therapy, conditions: Photomedicine, conditions: Low-Level Laser Therapy, conditions: Performance Enhancement, conditions: Quadriceps, conditions: Special Operations Readiness, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Approach: Special Operators attending THOR3 coach led training will be invited to participate. After consenting and screening for inclusion/exclusion, participants will be randomized into two groups: 1) sham PBMT and 2) PBMT (applied to quadriceps up to 3 times per week, post coach-led training, taking approximately 5-20 minutes each time). Baseline measurements will include body fat percentage, height, weight and military/demographic information. Metrics for counter movement jump and self-reported delayed muscle onset soreness will be taken at baseline and weekly for three weeks. Isokinetic dynamometer measurements for the lower extremities, and self-reported exertion and fatigue will be taken at baseline and at the 3-week follow-up (post three-week intervention). Oura rings will be assigned at baseline and will continuously measure sleep, heart rate, Sp02, and activity. Activity and pain will also be self-reported throughout the duration of the study., primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, maskingDescription: In order to facilitate participant blinding to their randomized study group, all participants (regardless of their assigned study group) will be asked to wear blackout glasses and headphones during their treatment., whoMasked: PARTICIPANT, enrollmentInfo count: 116, type: ESTIMATED, armsInterventionsModule interventions name: THOR3 training + Photobiomodulation Therapy (PBMT), interventions name: THOR3 training + sham PBMT, outcomesModule primaryOutcomes measure: Countermovement Jump (CMJ) initial baseline: deceleration/concentric impulse, primaryOutcomes measure: Countermovement Jump (CMJ) initial baseline: peak force production, primaryOutcomes measure: Countermovement Jump (CMJ) initial baseline: rate of force production, primaryOutcomes measure: Countermovement Jump (CMJ) initial baseline: unilateral performance comparison, primaryOutcomes measure: Countermovement Jump (CMJ) week 1 follow-up: deceleration/concentric impulse, primaryOutcomes measure: Countermovement Jump (CMJ) week 1 follow-up: peak force production, primaryOutcomes measure: Countermovement Jump (CMJ) week 1 follow-up: rate of force production, primaryOutcomes measure: Countermovement Jump (CMJ) week 1 follow-up: unilateral performance comparison, primaryOutcomes measure: Countermovement Jump (CMJ) week 2 follow-up: deceleration/concentric impulse, primaryOutcomes measure: Countermovement Jump (CMJ) week 2 follow-up: peak force production, primaryOutcomes measure: Countermovement Jump (CMJ) week 2 follow-up: rate of force production, primaryOutcomes measure: Countermovement Jump (CMJ) week 2 follow-up: unilateral performance comparison, primaryOutcomes measure: Countermovement Jump (CMJ) week 3 follow-up: deceleration/concentric impulse, primaryOutcomes measure: Countermovement Jump (CMJ) week 3 follow-up: peak force production, primaryOutcomes measure: Countermovement Jump (CMJ) week 3 follow-up: rate of force production, primaryOutcomes measure: Countermovement Jump (CMJ) week 3 follow-up: unilateral performance comparison, primaryOutcomes measure: Isometric Quadriceps Strength Testing initial baseline, primaryOutcomes measure: Isometric Hamstrings Strength Testing initial baseline, primaryOutcomes measure: Isokinetic Quadriceps Strength Testing initial baseline, primaryOutcomes measure: Isokinetic Hamstrings Strength Testing initial baseline, primaryOutcomes measure: Isometric Quadriceps Strength Testing 3-week follow-up, primaryOutcomes measure: Isometric Hamstrings Strength Testing 3-week follow-up, primaryOutcomes measure: Isokinetic Quadriceps Strength Testing 3-week follow-up, primaryOutcomes measure: Isokinetic Hamstrings Strength Testing 3-week follow-up, primaryOutcomes measure: Defense and Veteran's Pain Rating Scale (DVPRS) initial baseline, primaryOutcomes measure: Defense and Veteran's Pain Rating Scale (DVPRS) daily reports, primaryOutcomes measure: Visual Analog Scale (VAS) initial baseline, primaryOutcomes measure: Visual Analog Scale (VAS) week 1 follow-up, primaryOutcomes measure: Visual Analog Scale (VAS) week 2 follow-up, primaryOutcomes measure: Visual Analog Scale (VAS) week 3 follow-up, primaryOutcomes measure: Borg Modified Rating of Perceived Exertion (RPE) initial baseline, primaryOutcomes measure: Borg Modified Rating of Perceived Exertion (RPE) 3-week follow-up, primaryOutcomes measure: Elloumi fatigue scale initial baseline, primaryOutcomes measure: Elloumi fatigue scale 3-week follow-up, primaryOutcomes measure: Quick Physical Activity Rating scale (QPAR), primaryOutcomes measure: Oura Ring Sleep Data: sleep metrics - sleep duration, primaryOutcomes measure: Oura Ring Sleep Data: sleep metrics - time in bed, primaryOutcomes measure: Oura Ring Sleep Data: sleep metrics - light sleep length, primaryOutcomes measure: Oura Ring Sleep Data: sleep metrics - rapid eye movement (REM) sleep length, primaryOutcomes measure: Oura Ring Sleep Data: sleep metrics - deep sleep length, primaryOutcomes measure: Oura Ring Sleep Data: sleep metrics - sleep latency, primaryOutcomes measure: Oura Ring Sleep Data: sleep metrics - sleep efficiency score, primaryOutcomes measure: Oura Ring Sleep Data: sleep metrics - sleep quality score, primaryOutcomes measure: Oura Ring Sleep Data: Readiness trends - body temperature changes, primaryOutcomes measure: Oura Ring Sleep Data: Readiness trends - heart rate changes, primaryOutcomes measure: Oura Ring Sleep Data: Readiness trends - heart rate variability (HRV), primaryOutcomes measure: Oura Ring Sleep Data: Readiness trends - respiration rate, primaryOutcomes measure: Oura Ring Sleep Data: Readiness trends - blood oxygen saturation, primaryOutcomes measure: Oura Ring Sleep Data: Readiness trends - sleep regularity, primaryOutcomes measure: Oura Ring Sleep Data: Readiness trends - readiness score, otherOutcomes measure: Body Measurements: Height (cm), otherOutcomes measure: Body Measurements: Weight (kg/lbs), otherOutcomes measure: Body Measurements: Body composition (% body fat), otherOutcomes measure: Body Measurements: C1 - proximal thigh circumference (cm), otherOutcomes measure: Body Measurements: C2 - distal thigh circumference (cm), otherOutcomes measure: Body Measurements: L1 - length of thigh (cm), eligibilityModule sex: MALE, minimumAge: 18 Years, maximumAge: 45 Years, stdAges: ADULT, contactsLocationsModule, documentSection largeDocumentModule largeDocs typeAbbrev: Prot_SAP, hasProtocol: True, hasSap: True, hasIcf: False, label: Study Protocol and Statistical Analysis Plan, date: 2024-03-20, uploadDate: 2024-03-29T15:19, filename: Prot_SAP_000.pdf, size: 435470, largeDocs typeAbbrev: ICF, hasProtocol: False, hasSap: False, hasIcf: True, label: Informed Consent Form, date: 2024-03-19, uploadDate: 2024-03-29T15:20, filename: ICF_001.pdf, size: 165533, hasResults: False