Clinical trial NCT06380179: Photomedicine Project 14: PBMT for Performance Enhancement in SOF
Official title: Assessing the Impact of Post-Exercise Photobiomodulation Application on Performance, Recovery, and Behavioral State in Trained Special Operator Population
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Photobiomodulation Therapy
Photomedicine
Low-Level Laser Therapy
Performance Enhancement
Quadriceps
Special Operations Readiness
Lead sponsor: Musculoskeletal Injury Rehabilitation Research for Operational Readiness
Sponsor class: FED
Collaborators: name: Uniformed Services University (USU) of the Health Sciences
name: 1st Special Forces Group (Airborne), United States Army
name: United States Army Special Operations Command
name: The Geneva Foundation
First posted: 2024-04-23
Enrollment: 116
Sex: MALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* Active-Duty Special Forces Personnel (18-series)
* Able to read and understand English language for consent purposes
* Able to commit to study intervention and follow-up
* Able to participate in THOR3 coach-lead training, without restriction

Exclusion Criteria:

* Obese (body fat \> 25%)
* Cardiovascular disease
* Use of select medications (e.g., statins, diuretics, hypertensive agents)
* Female
* Tattoo in treatment area (body region)
* Diagnosis with porphyria (light induced allergy) or photosensitive eczema
* Current use of medications associated with sensitivity to heat or light (e.g., amiodarone, chlorpromazine, doxycycline, hydrochlorothiazide, nalidixic acid, naproxen, piroxicam, tetracycline, thioridazine, voriconazole)
* Use of pacemaker/underlying cardiac disease
* Diagnosed with autoimmune disease(s)
* Albinism
* Peripheral Neuropathy

Primary outcomes:
measure: Countermovement Jump (CMJ) initial baseline: deceleration/concentric impulse
timeFrame: Collected prior to treatment starting at time of enrollment.
measure: Countermovement Jump (CMJ) initial baseline: peak force production
timeFrame: Collected prior to treatment starting at time of enrollment.
measure: Countermovement Jump (CMJ) initial baseline: rate of force production
timeFrame: Collected prior to treatment starting at time of enrollment.
measure: Countermovement Jump (CMJ) initial baseline: unilateral performance comparison
timeFrame: Collected prior to treatment starting at time of enrollment.
measure: Countermovement Jump (CMJ) week 1 follow-up: deceleration/concentric impulse
timeFrame: Collected at the end of week 1 prior to coach-led training.
measure: Countermovement Jump (CMJ) week 1 follow-up: peak force production
timeFrame: Collected at the end of week 1 prior to coach-led training.
measure: Countermovement Jump (CMJ) week 1 follow-up: rate of force production
timeFrame: Collected at the end of week 1 prior to coach-led training.
measure: Countermovement Jump (CMJ) week 1 follow-up: unilateral performance comparison
timeFrame: Collected at the end of week 1 prior to coach-led training.
measure: Countermovement Jump (CMJ) week 2 follow-up: deceleration/concentric impulse
timeFrame: Collected at the end of week 2 prior to coach-led training.
measure: Countermovement Jump (CMJ) week 2 follow-up: peak force production
timeFrame: Collected at the end of week 2 prior to coach-led training.
measure: Countermovement Jump (CMJ) week 2 follow-up: rate of force production
timeFrame: Collected at the end of week 2 prior to coach-led training.
measure: Countermovement Jump (CMJ) week 2 follow-up: unilateral performance comparison
timeFrame: Collected at the end of week 2 prior to coach-led training.
measure: Countermovement Jump (CMJ) week 3 follow-up: deceleration/concentric impulse
timeFrame: Collected at the end of week 3 prior to coach-led training.
measure: Countermovement Jump (CMJ) week 3 follow-up: peak force production
timeFrame: Collected at the end of week 3 prior to coach-led training.
measure: Countermovement Jump (CMJ) week 3 follow-up: rate of force production
timeFrame: Collected at the end of week 3 prior to coach-led training.
measure: Countermovement Jump (CMJ) week 3 follow-up: unilateral performance comparison
timeFrame: Collected at the end of week 3 prior to coach-led training.
measure: Isometric Quadriceps Strength Testing initial baseline
timeFrame: Collected prior to treatment starting at time of enrollment.
measure: Isometric Hamstrings Strength Testing initial baseline
timeFrame: Collected prior to treatment starting at time of enrollment.
measure: Isokinetic Quadriceps Strength Testing initial baseline
timeFrame: Collected prior to treatment starting at time of enrollment.
measure: Isokinetic Hamstrings Strength Testing initial baseline
timeFrame: Collected prior to treatment starting at time of enrollment.
measure: Isometric Quadriceps Strength Testing 3-week follow-up
timeFrame: Collected at the 3-week follow-up session prior to coach-led training.
measure: Isometric Hamstrings Strength Testing 3-week follow-up
timeFrame: Collected at the 3-week follow-up session prior to coach-led training.
measure: Isokinetic Quadriceps Strength Testing 3-week follow-up
timeFrame: Collected at the 3-week follow-up session prior to coach-led training.
measure: Isokinetic Hamstrings Strength Testing 3-week follow-up
timeFrame: Collected at the 3-week follow-up session prior to coach-led training.
measure: Defense and Veteran's Pain Rating Scale (DVPRS) initial baseline
timeFrame: Self-reported, daily from date of randomization through study completion after 3 weeks.
measure: Defense and Veteran's Pain Rating Scale (DVPRS) daily reports
timeFrame: Self-reported, daily from date of randomization through study completion after 3 weeks.
measure: Visual Analog Scale (VAS) initial baseline
timeFrame: Collected prior to treatment starting at time of enrollment.
measure: Visual Analog Scale (VAS) week 1 follow-up
timeFrame: Collected at the end of week 1 after coach-led training and laser treatment.
measure: Visual Analog Scale (VAS) week 2 follow-up
timeFrame: Collected at the end of week 2 after coach-led training and laser treatment.
measure: Visual Analog Scale (VAS) week 3 follow-up
timeFrame: Collected at the end of week 3 after coach-led training and laser treatment.
measure: Borg Modified Rating of Perceived Exertion (RPE) initial baseline
timeFrame: Collected prior to treatment starting at time of enrollment
measure: Borg Modified Rating of Perceived Exertion (RPE) 3-week follow-up
timeFrame: Collected at the 3-week follow-up session after coach-led training and laser treatment.
measure: Elloumi fatigue scale initial baseline
timeFrame: Collected prior to treatment starting at time of enrollment.
measure: Elloumi fatigue scale 3-week follow-up
timeFrame: Collected at the 3-week follow-up session after coach-led training and laser treatment.
measure: Quick Physical Activity Rating scale (QPAR)
timeFrame: Collected prior to treatment starting at time of enrollment.
measure: Oura Ring Sleep Data: sleep metrics - sleep duration
timeFrame: Oura data is collected from daily wear of ring from date of randomization through study completion after 3 weeks.
measure: Oura Ring Sleep Data: sleep metrics - time in bed
timeFrame: Oura data is collected from daily wear of ring from date of randomization through study completion after 3 weeks.
measure: Oura Ring Sleep Data: sleep metrics - light sleep length
timeFrame: Oura data is collected from daily wear of ring from date of randomization through study completion after 3 weeks.
measure: Oura Ring Sleep Data: sleep metrics - rapid eye movement (REM) sleep length
timeFrame: Oura data is collected from daily wear of ring from date of randomization through study completion after 3 weeks.
measure: Oura Ring Sleep Data: sleep metrics - deep sleep length
timeFrame: Oura data is collected from daily wear of ring from date of randomization through study completion after 3 weeks.
measure: Oura Ring Sleep Data: sleep metrics - sleep latency
timeFrame: Oura data is collected from daily wear of ring from date of randomization through study completion after 3 weeks.
measure: Oura Ring Sleep Data: sleep metrics - sleep efficiency score
timeFrame: Oura data is collected from daily wear of ring from date of randomization through study completion after 3 weeks.
measure: Oura Ring Sleep Data: sleep metrics - sleep quality score
timeFrame: Oura data is collected from daily wear of ring from date of randomization through study completion after 3 weeks.
measure: Oura Ring Sleep Data: Readiness trends - body temperature changes
timeFrame: Oura data is collected from daily wear of ring from date of randomization through study completion after 3 weeks.
measure: Oura Ring Sleep Data: Readiness trends - heart rate changes
timeFrame: Oura data is collected from daily wear of ring from date of randomization through study completion after 3 weeks.
measure: Oura Ring Sleep Data: Readiness trends - heart rate variability (HRV)
timeFrame: Oura data is collected from daily wear of ring from date of randomization through study completion after 3 weeks.
measure: Oura Ring Sleep Data: Readiness trends - respiration rate
timeFrame: Oura data is collected from daily wear of ring from date of randomization through study completion after 3 weeks.
measure: Oura Ring Sleep Data: Readiness trends - blood oxygen saturation
timeFrame: Oura data is collected from daily wear of ring from date of randomization through study completion after 3 weeks.
measure: Oura Ring Sleep Data: Readiness trends - sleep regularity
timeFrame: Oura data is collected from daily wear of ring from date of randomization through study completion after 3 weeks.
measure: Oura Ring Sleep Data: Readiness trends - readiness score
timeFrame: Oura data is collected from daily wear of ring from date of randomization through study completion after 3 weeks.
Secondary outcomes:
Other outcomes:
measure: Body Measurements: Height (cm)
timeFrame: Measured prior to treatment starting at time of enrollment.
measure: Body Measurements: Weight (kg/lbs)
timeFrame: Measured prior to treatment starting at time of enrollment.
measure: Body Measurements: Body composition (% body fat)
timeFrame: Measured prior to treatment starting at time of enrollment.
measure: Body Measurements: C1 - proximal thigh circumference (cm)
timeFrame: Measured prior to treatment starting at time of enrollment.
measure: Body Measurements: C2 - distal thigh circumference (cm)
timeFrame: Measured prior to treatment starting at time of enrollment.
measure: Body Measurements: L1 - length of thigh (cm)
timeFrame: Measured prior to treatment starting at time of enrollment.
Locations:
city: Joint Base Lewis McChord
country: United States
facility: Joint Base Lewis-McChord
state: Washington
Study officials:
affiliation: 1st Special Forces Group Tactical Human Optimization, Rapid Rehabilitation and Reconditioning (THOR3)
name: Bradley H Cornell, DPT
role: PRINCIPAL_INVESTIGATOR
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