Photomedicine Project 14: PBMT for Performance Enhancement in SOF (SOF)
18 maj 2026 uppdaterad av: Musculoskeletal Injury Rehabilitation Research for Operational Readiness
Bedöma effekten av fotobiomodulering efter träning på prestanda, återhämtning och beteendetillstånd hos utbildad specialoperatörspopulation
Special Operations Forces (SOF) tränar kontinuerligt för att upprätthålla toppprestanda. Således är de nästan alltid i ett tillstånd av återhämtning och i behov av icke-invasiva terapier för att hantera den tunga arbetsbelastningen. Fotobiomodulationsterapi (PBMT) är en icke-invasiv behandling där en lågnivålaser appliceras på kroppen för att förbättra läkning, återhämtning och prestation. Army Tactical Human Optimization Rapid Rehabilitation and Reconditioning (THOR3) ger en konsekvent väg för implementering av PBMT som en modalitet. Studier på idrottare har visat prestations- och återhämtningsfördelar med fokal applicering av PBMT före och efter träning. Även om det finns mindre bevis på de potentiella kognitiva/beteendemässiga effekterna av en systematisk applicering av PBMT, har självrapporterad trötthet också visat sig vara betydligt lägre i grupper med fokal PBMT-applicering jämfört med placebo. Vidare är PBMT-forskning på friska militära taktiska idrottare begränsad. PBMT kan vara ett lovande verktyg för att förbättra den fysiska prestationsförmågan genom att påskynda muskuloskeletal och psykologisk återhämtning i SOF-populationen. Utredarna syftar till att studera de fysiologiska och beteendemässiga effekterna av PBMT-applikation efter träning på prestanda hos SOF-operatörer.
Avsikten: Utredarna föreslår att genomföra en enkelblind randomiserad kontrollstudie med skenkontroll för att undersöka effektiviteten av att tillhandahålla PBMT efter fysisk träning i en SOF-population.
De specifika syftena med denna studie är att:
- Analysera och beskriv de fysiologiska effekterna, om några, av PBMT-applikation efter träning hos specialstyrkor som genomgår coachledd utbildning.
- Analysera och beskriv eventuella beteendeeffekter av PBMT-applikation efter träning hos specialstyrkor som genomgår coachledd utbildning.
- Utvärdera den övergripande kliniska nyttan av fokal PBMT efter fysisk träning i en US Army SOF, taktisk atletpopulation.
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Studietyp
Interventionell
Inskrivning (Faktisk)
29
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
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Washington
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Joint Base Lewis McChord, Washington, Förenta staterna, 98433
- Joint Base Lewis-McChord
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Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
Tar emot friska volontärer
Ja
Beskrivning
Inklusionskriterier:
- Active-Duty Special Forces Personal (18-serien)
- Kunna läsa och förstå engelska för samtyckesändamål
- Kunna engagera sig i studieintervention och uppföljning
- Kunna delta i THOR3 coach-lead utbildning, utan begränsning
Exklusions kriterier:
- Överviktiga (kroppsfett > 25%)
- Kardiovaskulär sjukdom
- Användning av utvalda läkemedel (t.ex. statiner, diuretika, hypertensiva medel)
- Kvinna
- Tatuering i behandlingsområde (kroppsregion)
- Diagnos med porfyri (ljusinducerad allergi) eller ljuskänsligt eksem
- Nuvarande användning av mediciner förknippade med känslighet för värme eller ljus (t.ex. amiodaron, klorpromazin, doxycyklin, hydroklortiazid, nalidixinsyra, naproxen, piroxikam, tetracyklin, tioridazin, vorikonazol)
- Användning av pacemaker/underliggande hjärtsjukdom
- Diagnostiserats med autoimmun(a) sjukdom(ar)
- Albinism
- Perifer neuropati
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Enda
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
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Sham Comparator: Sham PBMT
Införandet av sken-PBMT kommer att säkerställa att alla deltagares behandlingsprocedurer förblir desamma, med undantag för emission av fotoner (aktiv behandling), vilket gör att eventuella skillnader mellan grupper kan tillskrivas användningen av PBMT.
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Sham PBMT kommer att tillhandahållas av en utbildad studiegruppsmedlem.
Sham PBMT kommer att levereras på samma sätt som anges för PBMT-processen ovan, men enheten förblir i standbyläge (dvs. behandlingsläget kommer inte att aktiveras).
Eftersom infrarött ljus är osynligt för blotta ögat är den enda synliga skillnaden mellan behandlings- och standbylägen närvaron av några små bärnstensfärgade lampor (dessa lampor är tända under behandlingsläget).
Andra namn:
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Aktiv komparator: Photobiomodulation Treatment (PBMT)
PBMT will be delivered at 40 watts (W).
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.
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PBMT will be delivered at 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.
Andra namn:
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Countermovement Jump (CMJ) Initial Baseline: Concentric Impulse
Tidsram: Collected prior to treatment starting at time of enrollment.
|
Assesses dynamic strength performance, including concentric impulse via force plates and analysis software.
|
Collected prior to treatment starting at time of enrollment.
|
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Countermovement Jump (CMJ) Initial Baseline: Movement Start to Peak Power.
Tidsram: Collected prior to treatment starting at time of enrollment.
|
Assesses dynamic strength performance, including Movement start to peak power.
via force plates and analysis software.
|
Collected prior to treatment starting at time of enrollment.
|
|
Countermovement Jump (CMJ) Initial Baseline: Reactive Strength Index-modified (RSImod)
Tidsram: Collected prior to treatment starting at time of enrollment.
|
Assesses dynamic strength performance, including Reactive Strength Index-modified (RSImod) via force plates and analysis software. Reactive Strength Index-modified (RSImod) reflects the efficiency of force production during a countermovement jump. It is calculated as jump height divided by time to take-off. Higher values indicate better explosive performance and lower neuromuscular fatigue, whereas lower values indicate reduced efficiency or increased fatigue. The index ranges from 0 upward with no theoretical maximum; therefore, interpretation should rely on normative ranges or athlete-specific baselines. Reference categories: Lower performers (L): ~0.20-0.30 Moderate performers (M): ~0.30-0.45 Upper performers (U): ~0.45-0.70+ |
Collected prior to treatment starting at time of enrollment.
|
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Countermovement Jump (CMJ) Initial Baseline: Time to Take-Off
Tidsram: Collected prior to treatment starting at time of enrollment.
|
Assesses dynamic strength performance, including Time to Take-Off via force plates and analysis software.
|
Collected prior to treatment starting at time of enrollment.
|
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Countermovement Jump (CMJ) Week 1 Follow-up: Concentric Impulse
Tidsram: Collected at the end of week 1 prior to coach-led training.
|
Assesses dynamic strength performance, including concentric impulse via force plates and analysis software.
|
Collected at the end of week 1 prior to coach-led training.
|
|
Countermovement Jump (CMJ) Week 1 Follow-up: Movement Start to Peak Power
Tidsram: Collected at the end of week 1 prior to coach-led training.
|
Assesses dynamic strength performance, including Movement Start to peak Power via force plates and analysis software.
|
Collected at the end of week 1 prior to coach-led training.
|
|
Countermovement Jump (CMJ) Week 1 Follow-up: Reactive Strength Index-modified (RSImod)
Tidsram: Collected at the end of week 1 prior to coach-led training.
|
Assesses dynamic strength performance, including Reactive Strength Index-modified (RSImod) via force plates and analysis software. Reactive Strength Index-modified (RSImod) reflects the efficiency of force production during a countermovement jump. It is calculated as jump height divided by time to take-off. Higher values indicate better explosive performance and lower neuromuscular fatigue, whereas lower values indicate reduced efficiency or increased fatigue. The index ranges from 0 upward with no theoretical maximum; therefore, interpretation should rely on normative ranges or athlete-specific baselines. Reference categories: Lower performers (L): ~0.20-0.30 Moderate performers (M): ~0.30-0.45 Upper performers (U): ~0.45-0.70+ |
Collected at the end of week 1 prior to coach-led training.
|
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Countermovement Jump (CMJ) Week 1 Follow-up: Time to Take-Off
Tidsram: Collected at the end of week 1 prior to coach-led training.
|
Assesses dynamic strength performance, including Time to Take-Off via force plates and analysis software.
|
Collected at the end of week 1 prior to coach-led training.
|
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Countermovement Jump (CMJ) Week 2 Follow-up: Concentric Impulse
Tidsram: Collected at the end of week 2 prior to coach-led training.
|
Assesses dynamic strength performance, including concentric impulse via force plates and analysis software.
|
Collected at the end of week 2 prior to coach-led training.
|
|
Countermovement Jump (CMJ) Week 2 Follow-up: Movement Start to Peak Power
Tidsram: Collected at the end of week 2 prior to coach-led training.
|
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.
|
|
Countermovement Jump (CMJ) Week 2 Follow-up: Reactive Strength Index-modified (RSImod)
Tidsram: Collected at the end of week 2 prior to coach-led training.
|
Assesses dynamic strength performance, including Reactive Strength Index-modified (RSImod) via force plates and analysis software. Reactive Strength Index-modified (RSImod) reflects the efficiency of force production during a countermovement jump. It is calculated as jump height divided by time to take-off. Higher values indicate better explosive performance and lower neuromuscular fatigue, whereas lower values indicate reduced efficiency or increased fatigue. The index ranges from 0 upward with no theoretical maximum; therefore, interpretation should rely on normative ranges or athlete-specific baselines. Reference categories: Lower performers (L): ~0.20-0.30 Moderate performers (M): ~0.30-0.45 Upper performers (U): ~0.45-0.70+ |
Collected at the end of week 2 prior to coach-led training.
|
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Countermovement Jump (CMJ) Week 2 Follow-up: Time to Take-Off
Tidsram: Collected at the end of week 2 prior to coach-led training.
|
Assesses dynamic strength performance, including Time to Take-Off via force plates and analysis software.
|
Collected at the end of week 2 prior to coach-led training.
|
|
Countermovement Jump (CMJ) Week 3 Follow-up: Concentric Impulse
Tidsram: Collected at the end of week 3 prior to coach-led training.
|
Assesses dynamic strength performance, including concentric impulse via force plates and analysis software.
|
Collected at the end of week 3 prior to coach-led training.
|
|
Countermovement Jump (CMJ) Week 3 Follow-up: Movement Start to Peak Power
Tidsram: Collected at the end of week 3 prior to coach-led training.
|
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.
|
|
Countermovement Jump (CMJ) Week 3 Follow-up: Reactive Strength Index-modified (RSImod)
Tidsram: Collected at the end of week 3 prior to coach-led training.
|
Assesses dynamic strength performance, including Reactive Strength Index-modified (RSImod) via force plates and analysis software. Reactive Strength Index-modified (RSImod) reflects the efficiency of force production during a countermovement jump. It is calculated as jump height divided by time to take-off. Higher values indicate better explosive performance and lower neuromuscular fatigue, whereas lower values indicate reduced efficiency or increased fatigue. The index ranges from 0 upward with no theoretical maximum; therefore, interpretation should rely on normative ranges or athlete-specific baselines. Reference categories: Lower performers (L): ~0.20-0.30 Moderate performers (M): ~0.30-0.45 Upper performers (U): ~0.45-0.70+ |
Collected at the end of week 3 prior to coach-led training.
|
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Countermovement Jump (CMJ) Week 3 Follow-up: Time to Take-Off
Tidsram: Collected at the end of week 3 prior to coach-led training.
|
Assesses dynamic strength performance, including Time to Take-Off via force plates and analysis software.
|
Collected at the end of week 3 prior to coach-led training.
|
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Isometric Quadriceps Strength Testing Initial Baseline: Peak Torque
Tidsram: Collected prior to treatment starting at time of enrollment.
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Measuring isolated strength (Peak Torque).
|
Collected prior to treatment starting at time of enrollment.
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Isometric Hamstrings Strength Testing Initial Baseline: Peak Torque.
Tidsram: Collected prior to treatment starting at time of enrollment.
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Measuring isolated strength (Peak Torque).
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Collected prior to treatment starting at time of enrollment.
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Isokinetic Quadriceps Strength Testing Initial Baseline: Peak Torque
Tidsram: Collected prior to treatment starting at time of enrollment.
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Measuring isolated strength (Peak Torque).
|
Collected prior to treatment starting at time of enrollment.
|
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Isokinetic Hamstrings Strength Testing Initial Baseline: Peak Torque
Tidsram: Collected prior to treatment starting at time of enrollment.
|
Measuring isolated strength (Peak Torque).
|
Collected prior to treatment starting at time of enrollment.
|
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Isometric Quadriceps Strength Testing 3-week Follow-up: Peak Torque
Tidsram: Collected at the 3-week follow-up session prior to coach-led training.
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Measuring isolated strength (Peak Torque).
|
Collected at the 3-week follow-up session prior to coach-led training.
|
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Isometric Hamstrings Strength Testing 3-week Follow-up: Peak Torque.
Tidsram: Collected at the 3-week follow-up session prior to coach-led training.
|
Measuring isolated strength (Peak Torque).
|
Collected at the 3-week follow-up session prior to coach-led training.
|
|
Isokinetic Quadriceps Strength Testing 3-week Follow-up: Peak Torque
Tidsram: Collected at the 3-week follow-up session prior to coach-led training.
|
Measuring isolated strength (Peak Torque).
|
Collected at the 3-week follow-up session prior to coach-led training.
|
|
Isokinetic Hamstrings Strength Testing 3-week Follow-up: Peak Torque
Tidsram: Collected at the 3-week follow-up session prior to coach-led training.
|
Measuring isolated strength (Peak Torque).
|
Collected at the 3-week follow-up session prior to coach-led training.
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Defense and Veteran's Pain Rating Scale (DVPRS) Initial Baseline
Tidsram: Self-reported at baseline
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Captures subjective pain rating on a 0 - 10 scale (minimum - maximum; 0 = no pain, 10 = severe pain).
Higher scores equal worse outcomes.
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Self-reported at baseline
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Defense and Veteran's Pain Rating Scale (DVPRS) Daily Reports
Tidsram: Self-reported, daily after baseline through study completion after 3 weeks.
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Captures subjective pain rating on a 0 - 10 scale (minimum - maximum; 0 = no pain, 10 = severe pain).
Higher scores equals worse outcomes.
Calculation for this timepoint was dervied from averaging all daily pain scores into an aggregate value.
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Self-reported, daily after baseline through study completion after 3 weeks.
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Visual Analog Scale (VAS) Initial Baseline
Tidsram: Collected prior to treatment starting at time of enrollment.
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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."
Scores range from 0-100, with higher scores equaling worse outcomes.
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Collected prior to treatment starting at time of enrollment.
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Visual Analog Scale (VAS) Week 1 Follow-up
Tidsram: Collected at the end of week 1 after coach-led training and laser treatment.
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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."
Scores range from 0-100, with higher scores equaling worse outcomes.
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Collected at the end of week 1 after coach-led training and laser treatment.
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Visual Analog Scale (VAS) Week 2 Follow-up
Tidsram: Collected at the end of week 2 after coach-led training and laser treatment.
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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."
Scores range from 0-100, with higher scores equaling worse outcomes.
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Collected at the end of week 2 after coach-led training and laser treatment.
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Visual Analog Scale (VAS) Week 3 Follow-up
Tidsram: Collected at the end of week 3 after coach-led training and laser treatment.
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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."
Scores range from 0-100, with higher scores equaling worse outcomes.
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Collected at the end of week 3 after coach-led training and laser treatment.
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Borg Modified Rating of Perceived Exertion (RPE) Initial Baseline
Tidsram: Collected prior to treatment starting at time of enrollment
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Quantifying perceived exertion on 0-10 scale.
Higher scores indicate worse outcomes.
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Collected prior to treatment starting at time of enrollment
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Borg Modified Rating of Perceived Exertion (RPE) 3-week Follow-up
Tidsram: Collected at the 3-week follow-up session after coach-led training and laser treatment.
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Quantifying perceived exertion on 0-10 scale.
Higher scores indicate worse outcomes.
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Collected at the 3-week follow-up session after coach-led training and laser treatment.
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Elloumi Fatigue Scale Initial Baseline
Tidsram: Collected prior to treatment starting at time of enrollment.
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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).
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Collected prior to treatment starting at time of enrollment.
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Elloumi Fatigue Scale 3-week Follow-up
Tidsram: Collected at the 3-week follow-up session after coach-led training and laser treatment.
|
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).
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Collected at the 3-week follow-up session after coach-led training and laser treatment.
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Quick Physical Activity Rating Scale (QPAR)
Tidsram: Collected prior to treatment starting at time of enrollment.
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Higher scores indicate better outcome.
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.
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Collected prior to treatment starting at time of enrollment.
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Oura Ring Sleep Data: Sleep Metrics - Sleep Duration
Tidsram: Oura data is collected from daily wear of ring from date of randomization through study completion after 3 weeks.
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Oura Ring will continuously measure aspects of sleep, including duration of sleep.
Calculation for this measure was dervied from averaging all daily sleep scores into an aggregate value.
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Oura data is collected from daily wear of ring from date of randomization through study completion after 3 weeks.
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Oura Ring Sleep Data: Sleep Metrics - Time in Bed
Tidsram: Oura data is collected from daily wear of ring from date of randomization through study completion after 3 weeks.
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Oura Ring will continuously measure aspects of sleep, including time spent in bed.
Calculation for this measure was dervied from averaging all daily scores into an aggregate value.
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Oura data is collected from daily wear of ring from date of randomization through study completion after 3 weeks.
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Oura Ring Sleep Data: Sleep Metrics - Light Sleep Length
Tidsram: Oura data is collected from daily wear of ring from date of randomization through study completion after 3 weeks.
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Oura Ring will continuously measure aspects of sleep, including duration of light sleep stage.
Calculation for this measure was dervied from averaging all daily scores into an aggregate value.
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Oura data is collected from daily wear of ring from date of randomization through study completion after 3 weeks.
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Oura Ring Sleep Data: Sleep Metrics - Rapid Eye Movement (REM) Sleep Length
Tidsram: Oura data is collected from daily wear of ring from date of randomization through study completion after 3 weeks.
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Oura Ring will continuously measure aspects of sleep, including duration of REM sleep stage.
Calculation for this measure was dervied from averaging all daily scores into an aggregate value.
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Oura data is collected from daily wear of ring from date of randomization through study completion after 3 weeks.
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Oura Ring Sleep Data: Sleep Metrics - Deep Sleep Length
Tidsram: Oura data is collected from daily wear of ring from date of randomization through study completion after 3 weeks.
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Oura Ring will continuously measure aspects of sleep, including duration of deep sleep stage (seconds).
Calculation for this measure was dervied from averaging all daily scores into an aggregate value.
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Oura data is collected from daily wear of ring from date of randomization through study completion after 3 weeks.
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Oura Ring Sleep Data: Sleep Metrics - Sleep Latency
Tidsram: Oura data is collected from daily wear of ring from date of randomization through study completion after 3 weeks.
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Oura Ring will continuously measure aspects of sleep, including sleep latency (time taken to fall asleep in seconds).
Calculation for this measure was dervied from averaging all daily scores into an aggregate value.
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Oura data is collected from daily wear of ring from date of randomization through study completion after 3 weeks.
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Oura Ring Sleep Data: Sleep Metrics - Sleep Efficiency Percentage
Tidsram: Oura data is collected from daily wear of ring from date of randomization through study completion after 3 weeks.
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Oura Ring will continuously measure aspects of sleep, including sleep efficiency percentage (time spent in bed asleep).
Higher percentages are better.
0-100.
Calculation for this measure was dervied from averaging all daily scores into an aggregate value.
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Oura data is collected from daily wear of ring from date of randomization through study completion after 3 weeks.
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Oura Ring Sleep Data: Sleep Metrics - Sleep Quality Score
Tidsram: Oura data is collected from daily wear of ring from date of randomization through study completion after 3 weeks.
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Oura Ring will continuously measure aspects of sleep, including sleep quality score.
Scores range from 0-100 with higher scores being better outcomes.
Calculation for this measure was dervied from averaging all daily scores into an aggregate value.
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Oura data is collected from daily wear of ring from date of randomization through study completion after 3 weeks.
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Oura Ring Sleep Data: Readiness Trends - Body Temperature Changes
Tidsram: Oura data is collected from daily wear of ring from date of randomization through study completion after 3 weeks.
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Oura Ring will continuously measure changes in body temperature.
Oura calculates body-temperature readiness by measuring average skin temperature during sleep, comparing it to long-term baseline, and reporting the difference as a positive or negative deviation.
Calculation for this measure was dervied from averaging all daily scores into an aggregate value.
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Oura data is collected from daily wear of ring from date of randomization through study completion after 3 weeks.
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Oura Ring Data: Readiness Trends - Daily Heart Rate
Tidsram: Oura data is collected from daily wear of ring from date of randomization through study completion after 3 weeks.
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Oura Ring will continuously measure aspects of physical readiness trends, including changes in heart rate.
Calculation for this measure was dervied from averaging all daily scores into an aggregate value.
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Oura data is collected from daily wear of ring from date of randomization through study completion after 3 weeks.
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Oura Ring Sleep Data: Readiness Trends - Heart Rate Variability (HRV)
Tidsram: Oura data is collected from daily wear of ring from date of randomization through study completion after 3 weeks.
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Oura Ring will continuously measure aspects of physical readiness trends, including HRV - a measure of the fluctuation in the time intervals between adjacent heartbeats.
Calculation for this measure was dervied from averaging all daily scores into an aggregate value.
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Oura data is collected from daily wear of ring from date of randomization through study completion after 3 weeks.
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Oura Ring Sleep Data: Readiness Trends - Respiration Rate
Tidsram: Oura data is collected from daily wear of ring from date of randomization through study completion after 3 weeks.
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Oura Ring will continuously measure aspects of physical readiness trends, including respiratory rate.
Calculation for this measure was dervied from averaging all daily scores into an aggregate value.
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Oura data is collected from daily wear of ring from date of randomization through study completion after 3 weeks.
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Oura Ring Sleep Data: Readiness Trends - Blood Oxygen Saturation
Tidsram: Oura data is collected from daily wear of ring from date of randomization through study completion after 3 weeks.
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Oura Ring will continuously measure aspects of physical readiness trends, including blood oxygen saturation.
Calculation for this measure was dervied from averaging all daily scores into an aggregate value.
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Oura data is collected from daily wear of ring from date of randomization through study completion after 3 weeks.
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Oura Ring Sleep Data: Readiness Trends - Sleep Balance
Tidsram: Oura data is collected from daily wear of ring from date of randomization through study completion after 3 weeks.
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Oura Ring will continuously measure aspects of physical readiness trends, including sleep balance- a measure of how consistent nightly total sleep duration is compared to baseline, reported on a 0-100 scale where higher means sleep length is closely matched night-to-night.
Scores near 100 indicate very stable sleep duration that supports recovery; 60-80 indicates moderate variability that may mildly reduce readiness; scores below ~60 reflect inconsistent sleep duration likely to lower Readiness.
Higher scores are better outcomes.
Calculation for this measure was dervied from averaging all daily scores into an aggregate value.
|
Oura data is collected from daily wear of ring from date of randomization through study completion after 3 weeks.
|
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Oura Ring Sleep Data: Readiness Trends - Readiness Score
Tidsram: Oura data is collected from daily wear of ring from date of randomization through study completion after 3 weeks.
|
Oura Ring will continuously measure aspects of physical readiness trends, including readiness score.
The score ranges from 0-100, higher scores indicate better outcomes.
Calculation for this measure was dervied from averaging all daily scores into an aggregate value.
|
Oura data is collected from daily wear of ring from date of randomization through study completion after 3 weeks.
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Body Measurements: Body Composition (% Body Fat)
Tidsram: Measured prior to treatment starting at time of enrollment.
|
Biometrics
|
Measured prior to treatment starting at time of enrollment.
|
|
Body Measurements: Height (Inches)
Tidsram: Measured prior to treatment starting at time of enrollment.
|
Biometrics
|
Measured prior to treatment starting at time of enrollment.
|
|
Body Measurements: Weight (Lbs)
Tidsram: Measured prior to treatment starting at time of enrollment.
|
Biometrics
|
Measured prior to treatment starting at time of enrollment.
|
|
Body Measurements: C1 - Proximal Thigh Circumference (cm)
Tidsram: Measured prior to treatment starting at time of enrollment.
|
Biometrics - used to calculate PBMT dosage
|
Measured prior to treatment starting at time of enrollment.
|
|
Body Measurements: C2 - Distal Thigh Circumference (cm)
Tidsram: Measured prior to treatment starting at time of enrollment.
|
Biometrics - used to calculate PBMT dosage
|
Measured prior to treatment starting at time of enrollment.
|
|
Body Measurements: L1 - Length of Thigh (cm)
Tidsram: Measured prior to treatment starting at time of enrollment.
|
Biometrics - used to calculate PBMT dosage
|
Measured prior to treatment starting at time of enrollment.
|
Andra resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Kroppsmått: Höjd (cm)
Tidsram: Uppmätt före behandling med start vid tidpunkten för inskrivning.
|
Biometri
|
Uppmätt före behandling med start vid tidpunkten för inskrivning.
|
|
Kroppsmått: Vikt (kg/lbs)
Tidsram: Uppmätt före behandling med start vid tidpunkten för inskrivning.
|
Biometri
|
Uppmätt före behandling med start vid tidpunkten för inskrivning.
|
|
Kroppsmått: Kroppssammansättning (% kroppsfett)
Tidsram: Uppmätt före behandling med start vid tidpunkten för inskrivning.
|
Biometri
|
Uppmätt före behandling med start vid tidpunkten för inskrivning.
|
|
Kroppsmått: C1 - proximal låromkrets (cm)
Tidsram: Uppmätt före behandling med start vid tidpunkten för inskrivning.
|
Biometri - används för att beräkna PBMT-dosering
|
Uppmätt före behandling med start vid tidpunkten för inskrivning.
|
|
Kroppsmått: C2 - distal låromkrets (cm)
Tidsram: Uppmätt före behandling med start vid tidpunkten för inskrivning.
|
Biometri - används för att beräkna PBMT-dosering
|
Uppmätt före behandling med start vid tidpunkten för inskrivning.
|
|
Kroppsmått: L1 - lårlängd (cm)
Tidsram: Uppmätt före behandling med start vid tidpunkten för inskrivning.
|
Biometri - används för att beräkna PBMT-dosering
|
Uppmätt före behandling med start vid tidpunkten för inskrivning.
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Samarbetspartners
Utredare
- Huvudutredare: Tanner Santarelli, DPT, 1st Special Forces Group Tactical Human Optimization, Rapid Rehabilitation and Reconditioning (THOR3)
Publikationer och användbara länkar
Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.
Allmänna publikationer
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- Ailioaie LM, Litscher G. Photobiomodulation and Sports: Results of a Narrative Review. Life (Basel). 2021 Dec 3;11(12):1339. doi: 10.3390/life11121339.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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/
- 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.
Användbara länkar
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
23 januari 2025
Primärt slutförande (Faktisk)
2 mars 2026
Avslutad studie (Faktisk)
2 mars 2026
Studieregistreringsdatum
Först inskickad
13 mars 2024
Först inskickad som uppfyllde QC-kriterierna
18 april 2024
Första postat (Faktisk)
23 april 2024
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
15 juni 2026
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
18 maj 2026
Senast verifierad
1 maj 2026
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- USUHS.2023-126
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
JA
IPD-planbeskrivning
I Initial Consent Form (ICF) för denna forskningsstudie anges att avidentifierade forskningsdata kommer att delas med MIRROR och USU och bevaras på obestämd tid för eventuell användning i framtida forskning. Genom att samtycka till att delta i denna forskningsstudie, samtycker deltagarna till att tillåta oss att behålla deras avidentifierade forskningsdata på obestämd tid för eventuell användning i framtida forskning.
Deltagare kommer inte att ges möjlighet att välja bort att vi behåller deras avidentifierade forskningsdata på obestämd tid för eventuell framtida användning. ICF säger: "Om du inte vill att dina avidentifierade data som samlats in som en del av denna forskningsstudie ska behållas för användning i framtida forskningsstudier, bör du inte underteckna detta samtyckesformulär."
IPD-delning som stöder informationstyp
- STUDY_PROTOCOL
- SAV
- ICF
- ANALYTIC_CODE
- CSR
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Nej
Studerar en amerikansk FDA-reglerad produktprodukt
Ja
produkt tillverkad i och exporterad från U.S.A.
Ja
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .