Photomedicine Project 14: PBMT for Performance Enhancement in SOF

Low-Level Laser Therapy Clinical Trial

— SOF  

Official title:

Assessing the Impact of Post-Exercise Photobiomodulation Application on Performance, Recovery, and Behavioral State in Trained Special Operator Population

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06380179
• Other study ID #: USUHS.2023-126
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 2024
• Est. completion date: January 2026

Study information

• Verified date: April 2024
• Source: Musculoskeletal Injury Rehabilitation Research for Operational Readiness
• Contact: Bradley H Cornell, DPT
• Phone: 253-477-2130
• Email: bradley.h.cornell.mil[@]army.mil
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 116
• Est. completion date: January 2026
• Est. primary completion date: August 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Low-Level Laser Therapy
• Performance Enhancement
• Photobiomodulation Therapy

Intervention

Device:
• THOR3 training + Photobiomodulation Therapy (PBMT)
PBMT will be delivered at 32-40W (depending on participant skin pigmentation). PBMT will be applied to the quadriceps area. A study team member will use the quadriceps measurements of the treatment area to calculate the PBMT treatment time (approximately 5-20 minutes) and specified J/cm2. PBMT treatment will be provided 3 times per week, for 3 weeks. PBMT will be delivered by a trained study team member using the LightForce® XLi 40W device with the Smart Hand Piece technology, which has a built-in accelerometer in the hand piece that controls the speed of light delivery to the treatment area. The trained team members will use the Smart Hand Piece technology, which assesses the operator's speed and provides real-time visual and sensory feedback calibrated to shut-off when moving too slowly and warns the operator when moving too quickly by vibrating. Treatment is delivered through a flexible optical fiber threaded through the hand piece, which contains a rolling glass massage ball.
• THOR3 training + sham PBMT
Sham PBMT will be provided by a trained study team member. Sham PBMT will be delivered in the same manner as indicated for the PBMT process above, but the device will stay in standby mode (i.e., the treatment mode will not be turned on). As infrared light is invisible to the naked eye, the only visible difference between treatment and standby modes is the presence of a few tiny amber lights (these lights are on during treatment mode).

Locations

Country	Name	City	State
n/a

Sponsors (5)

Lead Sponsor	Collaborator
Musculoskeletal Injury Rehabilitation Research for Operational Readiness (MIRROR)	1st Special Forces Group (Airborne), United States Army, The Geneva Foundation, Uniformed Services University (USU) of the Health Sciences, United States Army Special Operations Command

References & Publications (23)

Ailioaie LM, Litscher G. Photobiomodulation and Sports: Results of a Narrative Review. Life (Basel). 2021 Dec 3;11(12):1339. doi: 10.3390/life11121339. — View Citation

Antonialli FC, De Marchi T, Tomazoni SS, Vanin AA, dos Santos Grandinetti V, de Paiva PR, Pinto HD, Miranda EF, de Tarso Camillo de Carvalho P, Leal-Junior EC. Phototherapy in skeletal muscle performance and recovery after exercise: effect of combination of super-pulsed laser and light-emitting diodes. Lasers Med Sci. 2014 Nov;29(6):1967-76. doi: 10.1007/s10103-014-1611-7. Epub 2014 Jun 19. — View Citation

Aver Vanin A, De Marchi T, Tomazoni SS, Tairova O, Leao Casalechi H, de Tarso Camillo de Carvalho P, Bjordal JM, Leal-Junior EC. Pre-Exercise Infrared Low-Level Laser Therapy (810 nm) in Skeletal Muscle Performance and Postexercise Recovery in Humans, What Is the Optimal Dose? A Randomized, Double-Blind, Placebo-Controlled Clinical Trial. Photomed Laser Surg. 2016 Oct;34(10):473-482. doi: 10.1089/pho.2015.3992. Epub 2016 Aug 29. — View Citation

Baroni BM, Leal Junior EC, De Marchi T, Lopes AL, Salvador M, Vaz MA. Low level laser therapy before eccentric exercise reduces muscle damage markers in humans. Eur J Appl Physiol. 2010 Nov;110(4):789-96. doi: 10.1007/s00421-010-1562-z. Epub 2010 Jul 3. — View Citation

Baroni BM, Rodrigues R, Freire BB, Franke Rde A, Geremia JM, Vaz MA. Effect of low-level laser therapy on muscle adaptation to knee extensor eccentric training. Eur J Appl Physiol. 2015 Mar;115(3):639-47. doi: 10.1007/s00421-014-3055-y. Epub 2014 Nov 23. — View Citation

de Carvalho G, Gobbi A, Gobbi RB, Alfredo DMN, do Carmo Furquim TH, Barbosa RI, Papoti M, de Jesus Guirro RR. Photobiomodulation by light emitting diode applied sequentially does not alter performance in cycling athletes. Lasers Med Sci. 2020 Oct;35(8):1769-1779. doi: 10.1007/s10103-020-02973-9. Epub 2020 Feb 20. — View Citation

De Marchi T, Leal-Junior ECP, Lando KC, Cimadon F, Vanin AA, da Rosa DP, Salvador M. Photobiomodulation therapy before futsal matches improves the staying time of athletes in the court and accelerates post-exercise recovery. Lasers Med Sci. 2019 Feb;34(1):139-148. doi: 10.1007/s10103-018-2643-1. Epub 2018 Sep 27. — View Citation

de Oliveira AR, Vanin AA, Tomazoni SS, Miranda EF, Albuquerque-Pontes GM, De Marchi T, Dos Santos Grandinetti V, de Paiva PRV, Imperatori TBG, de Carvalho PTC, Bjordal JM, Leal-Junior ECP. Pre-Exercise Infrared Photobiomodulation Therapy (810 nm) in Skeletal Muscle Performance and Postexercise Recovery in Humans: What Is the Optimal Power Output? Photomed Laser Surg. 2017 Nov;35(11):595-603. doi: 10.1089/pho.2017.4343. — View Citation

de Paiva PR, Tomazoni SS, Johnson DS, Vanin AA, Albuquerque-Pontes GM, Machado CD, Casalechi HL, de Carvalho PT, Leal-Junior EC. Photobiomodulation therapy (PBMT) and/or cryotherapy in skeletal muscle restitution, what is better? A randomized, double-blinded, placebo-controlled clinical trial. Lasers Med Sci. 2016 Dec;31(9):1925-1933. doi: 10.1007/s10103-016-2071-z. Epub 2016 Sep 13. — View Citation

Dompe C, Moncrieff L, Matys J, Grzech-Lesniak K, Kocherova I, Bryja A, Bruska M, Dominiak M, Mozdziak P, Skiba THI, Shibli JA, Angelova Volponi A, Kempisty B, Dyszkiewicz-Konwinska M. Photobiomodulation-Underlying Mechanism and Clinical Applications. J Clin Med. 2020 Jun 3;9(6):1724. doi: 10.3390/jcm9061724. — View Citation

Dornelles MP, Fritsch CG, Sonda FC, Johnson DS, Leal-Junior ECP, Vaz MA, Baroni BM. Photobiomodulation therapy as a tool to prevent hamstring strain injuries by reducing soccer-induced fatigue on hamstring muscles. Lasers Med Sci. 2019 Aug;34(6):1177-1184. doi: 10.1007/s10103-018-02709-w. Epub 2019 Jan 3. — View Citation

Faul F, Erdfelder E, Lang AG, Buchner A. G*Power 3: a flexible statistical power analysis program for the social, behavioral, and biomedical sciences. Behav Res Methods. 2007 May;39(2):175-91. doi: 10.3758/bf03193146. — View Citation

Ferraresi C, Bertucci D, Schiavinato J, Reiff R, Araujo A, Panepucci R, Matheucci E Jr, Cunha AF, Arakelian VM, Hamblin MR, Parizotto N, Bagnato V. Effects of Light-Emitting Diode Therapy on Muscle Hypertrophy, Gene Expression, Performance, Damage, and Delayed-Onset Muscle Soreness: Case-control Study with a Pair of Identical Twins. Am J Phys Med Rehabil. 2016 Oct;95(10):746-57. doi: 10.1097/PHM.0000000000000490. — View Citation

Ferraresi C, Dos Santos RV, Marques G, Zangrande M, Leonaldo R, Hamblin MR, Bagnato VS, Parizotto NA. Light-emitting diode therapy (LEDT) before matches prevents increase in creatine kinase with a light dose response in volleyball players. Lasers Med Sci. 2015 May;30(4):1281-7. doi: 10.1007/s10103-015-1728-3. Epub 2015 Feb 27. — View Citation

Hamblin MR. Shining light on the head: Photobiomodulation for brain disorders. BBA Clin. 2016 Oct 1;6:113-124. doi: 10.1016/j.bbacli.2016.09.002. eCollection 2016 Dec. — View Citation

Leal Junior EC, de Godoi V, Mancalossi JL, Rossi RP, De Marchi T, Parente M, Grosselli D, Generosi RA, Basso M, Frigo L, Tomazoni SS, Bjordal JM, Lopes-Martins RA. Comparison between cold water immersion therapy (CWIT) and light emitting diode therapy (LEDT) in short-term skeletal muscle recovery after high-intensity exercise in athletes--preliminary results. Lasers Med Sci. 2011 Jul;26(4):493-501. doi: 10.1007/s10103-010-0866-x. Epub 2010 Nov 19. — View Citation

Leal Junior EC, Lopes-Martins RA, Baroni BM, De Marchi T, Rossi RP, Grosselli D, Generosi RA, de Godoi V, Basso M, Mancalossi JL, Bjordal JM. Comparison between single-diode low-level laser therapy (LLLT) and LED multi-diode (cluster) therapy (LEDT) applications before high-intensity exercise. Photomed Laser Surg. 2009 Aug;27(4):617-23. doi: 10.1089/pho.2008.2350. — View Citation

Pinto HD, Vanin AA, Miranda EF, Tomazoni SS, Johnson DS, Albuquerque-Pontes GM, Aleixo IO Junior, Grandinetti VD, Casalechi HL, de Carvalho PT, Leal-Junior EC. Photobiomodulation Therapy Improves Performance and Accelerates Recovery of High-Level Rugby Players in Field Test: A Randomized, Crossover, Double-Blind, Placebo-Controlled Clinical Study. J Strength Cond Res. 2016 Dec;30(12):3329-3338. doi: 10.1519/JSC.0000000000001439. — View Citation

Rossato M, Dellagrana RA, Sakugawa RL, Baroni BM, Diefenthaeler F. Dose-Response Effect of Photobiomodulation Therapy on Muscle Performance and Fatigue During a Multiple-Set Knee Extension Exercise: A Randomized, Crossover, Double-Blind Placebo-Controlled Trial. Photobiomodul Photomed Laser Surg. 2020 Dec;38(12):758-765. doi: 10.1089/photob.2020.4820. Epub 2020 Nov 24. — View Citation

Tomazoni SS, Machado CDSM, De Marchi T, Casalechi HL, Bjordal JM, de Carvalho PTC, Leal-Junior ECP. Infrared Low-Level Laser Therapy (Photobiomodulation Therapy) before Intense Progressive Running Test of High-Level Soccer Players: Effects on Functional, Muscle Damage, Inflammatory, and Oxidative Stress Markers-A Randomized Controlled Trial. Oxid Med Cell Longev. 2019 Nov 16;2019:6239058. doi: 10.1155/2019/6239058. eCollection 2019. — View Citation

Vanin AA, Miranda EF, Machado CS, de Paiva PR, Albuquerque-Pontes GM, Casalechi HL, de Tarso Camillo de Carvalho P, Leal-Junior EC. What is the best moment to apply phototherapy when associated to a strength training program? A randomized, double-blinded, placebo-controlled trial : Phototherapy in association to strength training. Lasers Med Sci. 2016 Nov;31(8):1555-1564. doi: 10.1007/s10103-016-2015-7. Epub 2016 Jul 1. Erratum In: Lasers Med Sci. 2017 Jan;32(1):253. — View Citation

Vieira WH, Ferraresi C, Perez SE, Baldissera V, Parizotto NA. Effects of low-level laser therapy (808 nm) on isokinetic muscle performance of young women submitted to endurance training: a randomized controlled clinical trial. Lasers Med Sci. 2012 Mar;27(2):497-504. doi: 10.1007/s10103-011-0984-0. Epub 2011 Aug 26. — View Citation

Wyatt Daniel Army Staff SGT. Program boosts special forces members' physical, mental capabilities. U.S. Department of Defense. December 6, 2017. Accessed July 13, 2022. https://www.defense.gov/News/News-Stories/Article/Article/1389545/program-boosts-specialforces- members-physical-mental-capabilities/

* Note: There are 23 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Body Measurements: Height (cm)	Biometrics	Measured prior to treatment starting at time of enrollment.
Other	Body Measurements: Weight (kg/lbs)	Biometrics	Measured prior to treatment starting at time of enrollment.
Other	Body Measurements: Body composition (% body fat)	Biometrics	Measured prior to treatment starting at time of enrollment.
Other	Body Measurements: C1 - proximal thigh circumference (cm)	Biometrics - used to calculate PBMT dosage	Measured prior to treatment starting at time of enrollment.
Other	Body Measurements: C2 - distal thigh circumference (cm)	Biometrics - used to calculate PBMT dosage	Measured prior to treatment starting at time of enrollment.
Other	Body Measurements: L1 - length of thigh (cm)	Biometrics - used to calculate PBMT dosage	Measured prior to treatment starting at time of enrollment.
Primary	Countermovement Jump (CMJ) initial baseline: deceleration/concentric impulse	Assesses dynamic strength performance, including deceleration/concentric impulse via force plates and analysis software.	Collected prior to treatment starting at time of enrollment.
Primary	Countermovement Jump (CMJ) initial baseline: peak force production	Assesses dynamic strength performance, including peak force production via force plates and analysis software.	Collected prior to treatment starting at time of enrollment.
Primary	Countermovement Jump (CMJ) initial baseline: rate of force production	Assesses dynamic strength performance, including rate of force production via force plates and analysis software.	Collected prior to treatment starting at time of enrollment.
Primary	Countermovement Jump (CMJ) initial baseline: unilateral performance comparison	Assesses dynamic strength performance, including comparisons between unilateral lower extremity performance via force plates and analysis software.	Collected prior to treatment starting at time of enrollment.
Primary	Countermovement Jump (CMJ) week 1 follow-up: deceleration/concentric impulse	Assesses dynamic strength performance, including deceleration/concentric impulse via force plates and analysis software.	Collected at the end of week 1 prior to coach-led training.
Primary	Countermovement Jump (CMJ) week 1 follow-up: peak force production	Assesses dynamic strength performance, including peak force production via force plates and analysis software.	Collected at the end of week 1 prior to coach-led training.
Primary	Countermovement Jump (CMJ) week 1 follow-up: rate of force production	Assesses dynamic strength performance, including rate of force production via force plates and analysis software.	Collected at the end of week 1 prior to coach-led training.
Primary	Countermovement Jump (CMJ) week 1 follow-up: unilateral performance comparison	Assesses dynamic strength performance, including comparisons between unilateral lower extremity performance via force plates and analysis software.	Collected at the end of week 1 prior to coach-led training.
Primary	Countermovement Jump (CMJ) week 2 follow-up: deceleration/concentric impulse	Assesses dynamic strength performance, including deceleration/concentric impulse via force plates and analysis software.	Collected at the end of week 2 prior to coach-led training.
Primary	Countermovement Jump (CMJ) week 2 follow-up: peak force production	Assesses dynamic strength performance, including peak force production via force plates and analysis software.	Collected at the end of week 2 prior to coach-led training.
Primary	Countermovement Jump (CMJ) week 2 follow-up: rate of force production	Assesses dynamic strength performance, including rate of force production via force plates and analysis software.	Collected at the end of week 2 prior to coach-led training.
Primary	Countermovement Jump (CMJ) week 2 follow-up: unilateral performance comparison	Assesses dynamic strength performance, including comparisons between unilateral lower extremity performance via force plates and analysis software.	Collected at the end of week 2 prior to coach-led training.
Primary	Countermovement Jump (CMJ) week 3 follow-up: deceleration/concentric impulse	Assesses dynamic strength performance, including deceleration/concentric impulse via force plates and analysis software.	Collected at the end of week 3 prior to coach-led training.
Primary	Countermovement Jump (CMJ) week 3 follow-up: peak force production	Assesses dynamic strength performance, including peak force production via force plates and analysis software.	Collected at the end of week 3 prior to coach-led training.
Primary	Countermovement Jump (CMJ) week 3 follow-up: rate of force production	Assesses dynamic strength performance, including rate of force production via force plates and analysis software.	Collected at the end of week 3 prior to coach-led training.
Primary	Countermovement Jump (CMJ) week 3 follow-up: unilateral performance comparison	Assesses dynamic strength performance, including comparisons between unilateral lower extremity performance via force plates and analysis software.	Collected at the end of week 3 prior to coach-led training.
Primary	Isometric Quadriceps Strength Testing initial baseline	Measuring isolated strength.	Collected prior to treatment starting at time of enrollment.
Primary	Isometric Hamstrings Strength Testing initial baseline	Measuring isolated strength.	Collected prior to treatment starting at time of enrollment.
Primary	Isokinetic Quadriceps Strength Testing initial baseline	Measuring isolated strength.	Collected prior to treatment starting at time of enrollment.
Primary	Isokinetic Hamstrings Strength Testing initial baseline	Measuring isolated strength.	Collected prior to treatment starting at time of enrollment.
Primary	Isometric Quadriceps Strength Testing 3-week follow-up	Measuring isolated strength.	Collected at the 3-week follow-up session prior to coach-led training.
Primary	Isometric Hamstrings Strength Testing 3-week follow-up	Measuring isolated strength.	Collected at the 3-week follow-up session prior to coach-led training.
Primary	Isokinetic Quadriceps Strength Testing 3-week follow-up	Measuring isolated strength.	Collected at the 3-week follow-up session prior to coach-led training.
Primary	Isokinetic Hamstrings Strength Testing 3-week follow-up	Measuring isolated strength.	Collected at the 3-week follow-up session prior to coach-led training.
Primary	Defense and Veteran's Pain Rating Scale (DVPRS) initial baseline	Captures subjective pain rating on a 0 - 10 scale (minimum - maximum; 0 = no pain, 10 = severe pain)	Self-reported, daily from date of randomization through study completion after 3 weeks.
Primary	Defense and Veteran's Pain Rating Scale (DVPRS) daily reports	Captures subjective pain rating on a 0 - 10 scale (minimum - maximum; 0 = no pain, 10 = severe pain)	Self-reported, daily from date of randomization through study completion after 3 weeks.
Primary	Visual Analog Scale (VAS) initial baseline	Measures delayed onset muscle soreness. Respondents mark on a 10 centimeter line their current level of muscle soreness. The left end of the line represents "I feel no soreness in my muscles" and the right end represents "My muscles feel so sore, I don't want to move them."	Collected prior to treatment starting at time of enrollment.
Primary	Visual Analog Scale (VAS) week 1 follow-up	Measures delayed onset muscle soreness. Respondents mark on a 10 centimeter line their current level of muscle soreness. The left end of the line represents "I feel no soreness in my muscles" and the right end represents "My muscles feel so sore, I don't want to move them."	Collected at the end of week 1 after coach-led training and laser treatment.
Primary	Visual Analog Scale (VAS) week 2 follow-up	Measures delayed onset muscle soreness. Respondents mark on a 10 centimeter line their current level of muscle soreness. The left end of the line represents "I feel no soreness in my muscles" and the right end represents "My muscles feel so sore, I don't want to move them."	Collected at the end of week 2 after coach-led training and laser treatment.
Primary	Visual Analog Scale (VAS) week 3 follow-up	Measures delayed onset muscle soreness. Respondents mark on a 10 centimeter line their current level of muscle soreness. The left end of the line represents "I feel no soreness in my muscles" and the right end represents "My muscles feel so sore, I don't want to move them."	Collected at the end of week 3 after coach-led training and laser treatment.
Primary	Borg Modified Rating of Perceived Exertion (RPE) initial baseline	Quantifying perceived exertion on 0-10 scale.	Collected prior to treatment starting at time of enrollment
Primary	Borg Modified Rating of Perceived Exertion (RPE) 3-week follow-up	Quantifying perceived exertion on 0-10 scale.	Collected at the 3-week follow-up session after coach-led training and laser treatment.
Primary	Elloumi fatigue scale initial baseline	Behavioral health rating of fatigue. The short questionnaire of fatigue uses eight questions that highlight perception of training difficulty, sleep, leg discomfort, infection/colds, concentration, work efficacy, anxiety and overall stress. Each question is rated by the respondent on a 7-point scale: 1 point (not at all) to 7 points (very much). The summed total score of the 8 questions allows for a total score of fatigue (TSF). Total score of fatigue ranges from 8 points (not at all fatigued) to 56 points (very much fatigued).	Collected prior to treatment starting at time of enrollment.
Primary	Elloumi fatigue scale 3-week follow-up	Behavioral health rating of fatigue. The short questionnaire of fatigue uses eight questions that highlight perception of training difficulty, sleep, leg discomfort, infection/colds, concentration, work efficacy, anxiety and overall stress. Each question is rated by the respondent on a 7-point scale: 1 point (not at all) to 7 points (very much). The summed total score of the 8 questions allows for a total score of fatigue (TSF). Total score of fatigue ranges from 8 points (not at all fatigued) to 56 points (very much fatigued).	Collected at the 3-week follow-up session after coach-led training and laser treatment.
Primary	Quick Physical Activity Rating scale (QPAR)	Scaled rating of various types of physical activity participation. Respondent reporting quantifies the overall amount of physical activity that the respondent regularly engages in. Activities are weighted in intensity that ranges from 1 (light) to 3 (heavy). Activity weekly frequency reported as never (0 days), seldom (1-2 days), sometime (3-4 days), and often (5-7 days). Activity duration collected as less than one hour per day, 1-2 hours per day, and more than two hours per day. Intensity (1-3), frequency (0-3) and duration (1-3) scores are multiplied and provide a physical activity score that may range from 0 - 153 points, 0 being very low physical activity and 153 representing very high physical activity.	Collected prior to treatment starting at time of enrollment.
Primary	Oura Ring Sleep Data: sleep metrics - sleep duration	Oura Ring will continuously measure aspects of sleep, including duration of sleep.	Oura data is collected from daily wear of ring from date of randomization through study completion after 3 weeks.
Primary	Oura Ring Sleep Data: sleep metrics - time in bed	Oura Ring will continuously measure aspects of sleep, including time spent in bed.	Oura data is collected from daily wear of ring from date of randomization through study completion after 3 weeks.
Primary	Oura Ring Sleep Data: sleep metrics - light sleep length	Oura Ring will continuously measure aspects of sleep, including duration of light sleep stage.	Oura data is collected from daily wear of ring from date of randomization through study completion after 3 weeks.
Primary	Oura Ring Sleep Data: sleep metrics - rapid eye movement (REM) sleep length	Oura Ring will continuously measure aspects of sleep, including duration of REM sleep stage.	Oura data is collected from daily wear of ring from date of randomization through study completion after 3 weeks.
Primary	Oura Ring Sleep Data: sleep metrics - deep sleep length	Oura Ring will continuously measure aspects of sleep, including duration of deep sleep stage.	Oura data is collected from daily wear of ring from date of randomization through study completion after 3 weeks.
Primary	Oura Ring Sleep Data: sleep metrics - sleep latency	Oura Ring will continuously measure aspects of sleep, including sleep latency (time taken to fall asleep).	Oura data is collected from daily wear of ring from date of randomization through study completion after 3 weeks.
Primary	Oura Ring Sleep Data: sleep metrics - sleep efficiency score	Oura Ring will continuously measure aspects of sleep, including sleep efficiency score.	Oura data is collected from daily wear of ring from date of randomization through study completion after 3 weeks.
Primary	Oura Ring Sleep Data: sleep metrics - sleep quality score	Oura Ring will continuously measure aspects of sleep, including sleep quality score.	Oura data is collected from daily wear of ring from date of randomization through study completion after 3 weeks.
Primary	Oura Ring Sleep Data: Readiness trends - body temperature changes	Oura Ring will continuously measure aspects of physical readiness trends, including changes in body temperature.	Oura data is collected from daily wear of ring from date of randomization through study completion after 3 weeks.
Primary	Oura Ring Sleep Data: Readiness trends - heart rate changes	Oura Ring will continuously measure aspects of physical readiness trends, including changes in heart rate.	Oura data is collected from daily wear of ring from date of randomization through study completion after 3 weeks.
Primary	Oura Ring Sleep Data: Readiness trends - heart rate variability (HRV)	Oura Ring will continuously measure aspects of physical readiness trends, including HRV - a measure of the fluctuation in the time intervals between adjacent heartbeats.	Oura data is collected from daily wear of ring from date of randomization through study completion after 3 weeks.
Primary	Oura Ring Sleep Data: Readiness trends - respiration rate	Oura Ring will continuously measure aspects of physical readiness trends, including respiratory rate.	Oura data is collected from daily wear of ring from date of randomization through study completion after 3 weeks.
Primary	Oura Ring Sleep Data: Readiness trends - blood oxygen saturation	Oura Ring will continuously measure aspects of physical readiness trends, including blood oxygen saturation.	Oura data is collected from daily wear of ring from date of randomization through study completion after 3 weeks.
Primary	Oura Ring Sleep Data: Readiness trends - sleep regularity	Oura Ring will continuously measure aspects of physical readiness trends, including sleep regularity - a measure of consistency of bedtime, wake-time and duration sleep over a period of time.	Oura data is collected from daily wear of ring from date of randomization through study completion after 3 weeks.
Primary	Oura Ring Sleep Data: Readiness trends - readiness score	Oura Ring will continuously measure aspects of physical readiness trends, including readiness score - calculated from multiple other aspects of sleep data and readiness trends.	Oura data is collected from daily wear of ring from date of randomization through study completion after 3 weeks.

External Links

•   Homepage for all current Photomedicine projects, including PM#14.