14. fotomedicina projekt: PBMT a SOF teljesítménynövelésére (SOF)
2026. május 18. frissítette: Musculoskeletal Injury Rehabilitation Research for Operational Readiness
Az edzés utáni fotobiomodulációs alkalmazás teljesítményre, felépülésre és viselkedési állapotra gyakorolt hatásának felmérése képzett speciális kezelőpopulációban
A különleges műveleti erők (SOF) folyamatosan edzenek a csúcsteljesítmény fenntartása érdekében. Így szinte mindig gyógyuló állapotban vannak, és non-invazív terápiákra van szükségük a megterhelő munkaterhelés kezelésére. A fotobiomodulációs terápia (PBMT) egy nem invazív kezelés, amelynek során alacsony szintű lézert alkalmaznak a testre a gyógyulás, a felépülés és a teljesítmény fokozása érdekében. Army Tactical Human Optimization Rapid Rehabilitation and Reconditioning (THOR3) következetes utat biztosít a PBMT mint módozat megvalósításához. Sportolókon végzett vizsgálatok kimutatták a teljesítmény és a felépülés előnyeit a PBMT edzés előtti és utáni fókuszálásával. Noha kevesebb bizonyíték áll rendelkezésre a PBMT szisztematikus alkalmazásának lehetséges kognitív/viselkedési hatásaira vonatkozóan, az önbeszámolt fáradtság is szignifikánsan alacsonyabb volt azokban a csoportokban, ahol fókuszos PBMT-t alkalmaztak, mint a placebóval. Ezenkívül az egészséges katonai taktikai sportolók körében végzett PBMT-kutatás korlátozott. A PBMT ígéretes eszköz lehet a fizikai teljesítmény fokozására az SOF-populáció mozgásszervi és pszichológiai felépülésének felgyorsításával. A kutatók célja, hogy tanulmányozzák a PBMT alkalmazásának edzés utáni fiziológiai és viselkedési hatásait az SOF operátorok teljesítményére.
A szándék: A kutatók azt javasolják, hogy végezzenek egyszeri vak randomizált kontrollvizsgálatot álkontrollokkal, hogy megvizsgálják a PBMT fizikai edzés utáni hatékonyságát egy SOF populációban.
Ennek a tanulmánynak a konkrét céljai a következők:
- Elemezze és írja le a PBMT-alkalmazás fiziológiai hatásait, ha vannak ilyenek a gyakorlatok után az edző által vezetett képzésben részt vevő különleges erők operátorainál.
- Elemezze és írja le a PBMT alkalmazása gyakorlatok utáni viselkedési hatásait, ha vannak ilyenek olyan különleges erők operátorainál, akik edző által vezetett képzésen vesznek részt.
- Értékelje a fokális PBMT általános klinikai hasznosságát a fizikai edzést követően egy amerikai hadsereg SOF-ban, taktikai sportoló populációban.
A tanulmány áttekintése
Állapot
Befejezve
Körülmények
Tanulmány típusa
Beavatkozó
Beiratkozás (Tényleges)
29
Fázis
- Nem alkalmazható
Kapcsolatok és helyek
Ez a rész a vizsgálatot végzők elérhetőségeit, valamint a vizsgálat lefolytatásának helyére vonatkozó információkat tartalmazza.
Tanulmányi helyek
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Washington
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Joint Base Lewis McChord, Washington, Egyesült Államok, 98433
- Joint Base Lewis-McChord
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Részvételi kritériumok
A kutatók olyan embereket keresnek, akik megfelelnek egy bizonyos leírásnak, az úgynevezett jogosultsági kritériumoknak. Néhány példa ezekre a kritériumokra a személy általános egészségi állapota vagy a korábbi kezelések.
Jogosultsági kritériumok
Tanulmányozható életkorok
- Felnőtt
Egészséges önkénteseket fogad
Igen
Leírás
Bevételi kritériumok:
- Aktív szolgálatot teljesítő különleges erők személyzete (18-as sorozat)
- Képes olvasni és megérteni az angol nyelvet a beleegyezés céljából
- Képes elköteleződni a beavatkozás és a nyomon követés tanulmányozása mellett
- Korlátozás nélkül részt vehet a THOR3 edző-vezető képzésben
Kizárási kritériumok:
- elhízott (testzsír > 25%)
- Szív-és érrendszeri betegségek
- Bizonyos gyógyszerek (pl. sztatinok, vízhajtók, magas vérnyomású szerek) használata
- Női
- Tetoválás a kezelt területen (testtáj)
- Porfíria (fény által kiváltott allergia) vagy fényérzékeny ekcéma diagnózisa
- Hő- vagy fényérzékenységgel összefüggő gyógyszerek (pl. amiodaron, klórpromazin, doxiciklin, hidroklorotiazid, nalidixsav, naproxen, piroxikám, tetraciklin, tioridazin, vorikonazol) jelenlegi használata
- Pacemaker használata/alapos szívbetegség
- Autoimmun betegséggel diagnosztizáltak
- Albinizmus
- Perifériás neuropátia
Tanulási terv
Ez a rész a vizsgálati terv részleteit tartalmazza, beleértve a vizsgálat megtervezését és a vizsgálat mérését.
Hogyan készül a tanulmány?
Tervezési részletek
- Elsődleges cél: Kezelés
- Kiosztás: Véletlenszerűsített
- Beavatkozó modell: Párhuzamos hozzárendelés
- Maszkolás: Egyetlen
Fegyverek és beavatkozások
Résztvevő csoport / kar |
Beavatkozás / kezelés |
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Sham Comparator: Sham PBMT
Az ál-PBMT bevonása biztosítja, hogy minden résztvevő kezelési eljárás változatlan maradjon, kivéve a foton-emissziót (aktív kezelés), így lehetővé válik, hogy a csoportok közötti különbségek hozzájáruljanak a PBMT használatához.
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A Sham PBMT-t egy képzett tanulmányi csoporttag biztosítja.
Az ál-PBMT-t a fenti PBMT-folyamattal megegyező módon szállítják ki, de a készülék készenléti üzemmódban marad (azaz a kezelési mód nem lesz bekapcsolva).
Mivel az infravörös fény szabad szemmel nem látható, az egyetlen látható különbség a kezelési és a készenléti üzemmód között néhány apró borostyánsárga fény jelenléte (ezek a lámpák a kezelési módban világítanak).
Más nevek:
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Aktív összehasonlító: 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.
Más nevek:
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Mit mér a tanulmány?
Elsődleges eredményintézkedések
Eredménymérő |
Intézkedés leírása |
Időkeret |
|---|---|---|
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Countermovement Jump (CMJ) Initial Baseline: Concentric Impulse
Időkeret: Collected prior to treatment starting at time of enrollment.
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Assesses dynamic strength performance, including concentric impulse via force plates and analysis software.
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Collected prior to treatment starting at time of enrollment.
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Countermovement Jump (CMJ) Initial Baseline: Movement Start to Peak Power.
Időkeret: Collected prior to treatment starting at time of enrollment.
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Assesses dynamic strength performance, including Movement start to peak power.
via force plates and analysis software.
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Collected prior to treatment starting at time of enrollment.
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Countermovement Jump (CMJ) Initial Baseline: Reactive Strength Index-modified (RSImod)
Időkeret: Collected prior to treatment starting at time of enrollment.
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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
Időkeret: Collected prior to treatment starting at time of enrollment.
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Assesses dynamic strength performance, including Time to Take-Off via force plates and analysis software.
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Collected prior to treatment starting at time of enrollment.
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Countermovement Jump (CMJ) Week 1 Follow-up: Concentric Impulse
Időkeret: Collected at the end of week 1 prior to coach-led training.
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Assesses dynamic strength performance, including concentric impulse via force plates and analysis software.
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Collected at the end of week 1 prior to coach-led training.
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Countermovement Jump (CMJ) Week 1 Follow-up: Movement Start to Peak Power
Időkeret: Collected at the end of week 1 prior to coach-led training.
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Assesses dynamic strength performance, including Movement Start to peak Power via force plates and analysis software.
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Collected at the end of week 1 prior to coach-led training.
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Countermovement Jump (CMJ) Week 1 Follow-up: Reactive Strength Index-modified (RSImod)
Időkeret: Collected at the end of week 1 prior to coach-led training.
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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
Időkeret: Collected at the end of week 1 prior to coach-led training.
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Assesses dynamic strength performance, including Time to Take-Off via force plates and analysis software.
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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
Időkeret: Collected at the end of week 2 prior to coach-led training.
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Assesses dynamic strength performance, including concentric impulse via force plates and analysis software.
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Collected at the end of week 2 prior to coach-led training.
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Countermovement Jump (CMJ) Week 2 Follow-up: Movement Start to Peak Power
Időkeret: Collected at the end of week 2 prior to coach-led training.
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Assesses dynamic strength performance, including peak force production via force plates and analysis software.
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Collected at the end of week 2 prior to coach-led training.
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Countermovement Jump (CMJ) Week 2 Follow-up: Reactive Strength Index-modified (RSImod)
Időkeret: Collected at the end of week 2 prior to coach-led training.
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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
Időkeret: Collected at the end of week 2 prior to coach-led training.
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Assesses dynamic strength performance, including Time to Take-Off via force plates and analysis software.
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Collected at the end of week 2 prior to coach-led training.
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Countermovement Jump (CMJ) Week 3 Follow-up: Concentric Impulse
Időkeret: Collected at the end of week 3 prior to coach-led training.
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Assesses dynamic strength performance, including concentric impulse via force plates and analysis software.
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Collected at the end of week 3 prior to coach-led training.
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Countermovement Jump (CMJ) Week 3 Follow-up: Movement Start to Peak Power
Időkeret: Collected at the end of week 3 prior to coach-led training.
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Assesses dynamic strength performance, including peak force production via force plates and analysis software.
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Collected at the end of week 3 prior to coach-led training.
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Countermovement Jump (CMJ) Week 3 Follow-up: Reactive Strength Index-modified (RSImod)
Időkeret: Collected at the end of week 3 prior to coach-led training.
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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
Időkeret: Collected at the end of week 3 prior to coach-led training.
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Assesses dynamic strength performance, including Time to Take-Off via force plates and analysis software.
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Collected at the end of week 3 prior to coach-led training.
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Isometric Quadriceps Strength Testing Initial Baseline: Peak Torque
Időkeret: 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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Isometric Hamstrings Strength Testing Initial Baseline: Peak Torque.
Időkeret: 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
Időkeret: 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 Hamstrings Strength Testing Initial Baseline: Peak Torque
Időkeret: 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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Isometric Quadriceps Strength Testing 3-week Follow-up: Peak Torque
Időkeret: Collected at the 3-week follow-up session prior to coach-led training.
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Measuring isolated strength (Peak Torque).
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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.
Időkeret: Collected at the 3-week follow-up session prior to coach-led training.
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Measuring isolated strength (Peak Torque).
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Collected at the 3-week follow-up session prior to coach-led training.
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Isokinetic Quadriceps Strength Testing 3-week Follow-up: Peak Torque
Időkeret: Collected at the 3-week follow-up session prior to coach-led training.
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Measuring isolated strength (Peak Torque).
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Collected at the 3-week follow-up session prior to coach-led training.
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Isokinetic Hamstrings Strength Testing 3-week Follow-up: Peak Torque
Időkeret: Collected at the 3-week follow-up session prior to coach-led training.
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Measuring isolated strength (Peak Torque).
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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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: Collected at the 3-week follow-up session after coach-led training and laser treatment.
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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 at the 3-week follow-up session after coach-led training and laser treatment.
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Quick Physical Activity Rating Scale (QPAR)
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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.
|
Oura data is collected from daily wear of ring from date of randomization through study completion after 3 weeks.
|
|
Oura Ring Data: Readiness Trends - Daily Heart Rate
Időkeret: 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 changes in heart rate.
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.
|
|
Oura Ring Sleep Data: Readiness Trends - Heart Rate Variability (HRV)
Időkeret: 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 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.
|
Oura data is collected from daily wear of ring from date of randomization through study completion after 3 weeks.
|
|
Oura Ring Sleep Data: Readiness Trends - Respiration Rate
Időkeret: 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 respiratory rate.
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.
|
|
Oura Ring Sleep Data: Readiness Trends - Blood Oxygen Saturation
Időkeret: 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 blood oxygen saturation.
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.
|
|
Oura Ring Sleep Data: Readiness Trends - Sleep Balance
Időkeret: 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 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.
|
|
Oura Ring Sleep Data: Readiness Trends - Readiness Score
Időkeret: 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.
|
Másodlagos eredményintézkedések
Eredménymérő |
Intézkedés leírása |
Időkeret |
|---|---|---|
|
Body Measurements: Body Composition (% Body Fat)
Időkeret: Measured prior to treatment starting at time of enrollment.
|
Biometrics
|
Measured prior to treatment starting at time of enrollment.
|
|
Body Measurements: Height (Inches)
Időkeret: Measured prior to treatment starting at time of enrollment.
|
Biometrics
|
Measured prior to treatment starting at time of enrollment.
|
|
Body Measurements: Weight (Lbs)
Időkeret: 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)
Időkeret: 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)
Időkeret: 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)
Időkeret: Measured prior to treatment starting at time of enrollment.
|
Biometrics - used to calculate PBMT dosage
|
Measured prior to treatment starting at time of enrollment.
|
Egyéb eredményintézkedések
Eredménymérő |
Intézkedés leírása |
Időkeret |
|---|---|---|
|
Testméretek: Magasság (cm)
Időkeret: A kezelés megkezdése előtt, a beiratkozáskor mérve.
|
Biometrikus adatok
|
A kezelés megkezdése előtt, a beiratkozáskor mérve.
|
|
Testméretek: Súly (kg/lbs)
Időkeret: A kezelés megkezdése előtt, a beiratkozáskor mérve.
|
Biometrikus adatok
|
A kezelés megkezdése előtt, a beiratkozáskor mérve.
|
|
Testméretek: Testösszetétel (testzsír %)
Időkeret: A kezelés megkezdése előtt, a beiratkozáskor mérve.
|
Biometrikus adatok
|
A kezelés megkezdése előtt, a beiratkozáskor mérve.
|
|
Testméretek: C1 - proximális combkörfogat (cm)
Időkeret: A kezelés megkezdése előtt, a beiratkozáskor mérve.
|
Biometrikus adatok – a PBMT-dózis kiszámítására szolgál
|
A kezelés megkezdése előtt, a beiratkozáskor mérve.
|
|
Testméretek: C2 - disztális combkörfogat (cm)
Időkeret: A kezelés megkezdése előtt, a beiratkozáskor mérve.
|
Biometrikus adatok – a PBMT-dózis kiszámítására szolgál
|
A kezelés megkezdése előtt, a beiratkozáskor mérve.
|
|
Testméretek: L1 - combhossz (cm)
Időkeret: A kezelés megkezdése előtt, a beiratkozáskor mérve.
|
Biometrikus adatok – a PBMT-dózis kiszámítására szolgál
|
A kezelés megkezdése előtt, a beiratkozáskor mérve.
|
Együttműködők és nyomozók
Itt találhatja meg a tanulmányban érintett személyeket és szervezeteket.
Együttműködők
Nyomozók
- Kutatásvezető: Tanner Santarelli, DPT, 1st Special Forces Group Tactical Human Optimization, Rapid Rehabilitation and Reconditioning (THOR3)
Publikációk és hasznos linkek
A vizsgálattal kapcsolatos információk beviteléért felelős személy önkéntesen bocsátja rendelkezésre ezeket a kiadványokat. Ezek bármiről szólhatnak, ami a tanulmányhoz kapcsolódik.
Általános kiadványok
- 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.
Tanulmányi rekorddátumok
Ezek a dátumok nyomon követik a ClinicalTrials.gov webhelyre benyújtott vizsgálati rekordok és összefoglaló eredmények benyújtásának folyamatát. A vizsgálati feljegyzéseket és a jelentett eredményeket a Nemzeti Orvostudományi Könyvtár (NLM) felülvizsgálja, hogy megbizonyosodjon arról, hogy megfelelnek-e az adott minőség-ellenőrzési szabványoknak, mielőtt közzéteszik őket a nyilvános weboldalon.
Tanulmány főbb dátumok
Tanulmány kezdete (Tényleges)
2025. január 23.
Elsődleges befejezés (Tényleges)
2026. március 2.
A tanulmány befejezése (Tényleges)
2026. március 2.
Tanulmányi regisztráció dátumai
Először benyújtva
2024. március 13.
Először nyújtották be, amely megfelel a minőségbiztosítási kritériumoknak
2024. április 18.
Első közzététel (Tényleges)
2024. április 23.
Tanulmányi rekordok frissítései
Utolsó frissítés közzétéve (Tényleges)
2026. június 15.
Az utolsó frissítés elküldve, amely megfelel a minőségbiztosítási kritériumoknak
2026. május 18.
Utolsó ellenőrzés
2026. május 1.
Több információ
A tanulmányhoz kapcsolódó kifejezések
További vonatkozó MeSH feltételek
Egyéb vizsgálati azonosító számok
- USUHS.2023-126
Terv az egyéni résztvevői adatokhoz (IPD)
Tervezi megosztani az egyéni résztvevői adatokat (IPD)?
IGEN
IPD terv leírása
A kutatási tanulmány kezdeti hozzájárulási űrlapja (Initial Consent Form, ICF) kimondja, hogy az azonosítatlan kutatási adatokat megosztják a MIRROR-ral és az USU-val, és korlátlan ideig megőrzik azokat a jövőbeni kutatások során. Azzal, hogy hozzájárulnak a kutatási tanulmányban való részvételhez, a résztvevők beleegyeznek abba, hogy korlátlan ideig megőrizzük azonosítatlan kutatási adataikat későbbi kutatások során.
A résztvevők nem kaphatnak lehetőséget arra, hogy lemondjanak arról, hogy azonosítatlan kutatási adataikat korlátlan ideig megőrizzük esetleges későbbi felhasználás céljából. Az ICF kijelenti: "Ha nem szeretné, hogy a jelen kutatás részeként gyűjtött, azonosítatlan adatait megőrizzék későbbi kutatási vizsgálatokhoz, ne írja alá ezt a beleegyezési űrlapot."
Az IPD megosztását támogató információ típusa
- STUDY_PROTOCOL
- NEDV
- ICF
- ANALYTIC_CODE
- CSR
Gyógyszer- és eszközinformációk, tanulmányi dokumentumok
Egy amerikai FDA által szabályozott gyógyszerkészítményt tanulmányoz
Nem
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Igen
az Egyesült Államokban gyártott és onnan exportált termék
Igen
Ezt az információt közvetlenül a clinicaltrials.gov webhelyről szereztük be, változtatás nélkül. Ha bármilyen kérése van vizsgálati adatainak módosítására, eltávolítására vagy frissítésére, kérjük, írjon a következő címre: register@clinicaltrials.gov. Amint a változás bevezetésre kerül a clinicaltrials.gov oldalon, ez a webhelyünkön is automatikusan frissül. .