- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT06380179
Photomedicine Project 14: PBMT for Performance Enhancement in SOF (SOF)
Posouzení dopadu aplikace fotobiomodulace po cvičení na výkon, zotavení a stav chování v populaci vyškolených speciálních operátorů
Síly speciálních operací (SOF) neustále trénují, aby si udržely špičkový výkon. Jsou tedy téměř vždy ve stavu zotavení a potřebují neinvazivní terapie, aby se vypořádali s náročným pracovním zatížením. Fotobiomodulační terapie (PBMT) je neinvazivní léčba, při které se na tělo aplikuje nízkoúrovňový laser pro zlepšení hojení, zotavení a výkonu. Army Tactical Human Optimization Rychlá rehabilitace a rekondice (THOR3) poskytuje konzistentní cestu pro implementaci PBMT jako modality. Studie u sportovců prokázaly přínosy pro výkon a regeneraci s fokální aplikací PBMT před a po tréninku. I když existuje méně důkazů o potenciálních kognitivních/behaviorálních účincích systematické aplikace PBMT, bylo také zjištěno, že únava sama o sobě je významně nižší ve skupinách s fokální aplikací PBMT ve srovnání s placebem. Dále je výzkum PBMT u zdravých vojenských taktických sportovců omezený. PBMT může být slibným nástrojem pro zvýšení fyzického výkonu urychlením muskuloskeletální a psychické regenerace u populace SOF. Cílem výzkumných pracovníků je studovat fyziologické a behaviorální účinky aplikace PBMT po cvičení na výkon u operátorů SOF.
Záměr: Vyšetřovatelé navrhují provést jednoduše zaslepenou randomizovanou kontrolní studii s falešnou kontrolou, aby se prozkoumala účinnost poskytování PBMT po fyzickém tréninku v populaci SOF.
Konkrétní cíle této studie jsou:
- Analyzujte a popište případné fyziologické účinky aplikace PBMT po cvičení u operátorů speciálních sil, kteří podstupují výcvik vedený trenérem.
- Analyzujte a popište případné behaviorální účinky aplikace PBMT po cvičení u operátorů speciálních sil, kteří procházejí školením vedeným trenérem.
- Vyhodnoťte celkovou klinickou užitečnost fokální PBMT po fyzickém tréninku v populaci taktických sportovců US Army SOF.
Přehled studie
Postavení
Podmínky
Typ studie
Zápis (Aktuální)
Fáze
- Nelze použít
Kontakty a umístění
Studijní místa
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Washington
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Joint Base Lewis McChord, Washington, Spojené státy, 98433
- Joint Base Lewis-McChord
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
Přijímá zdravé dobrovolníky
Popis
Kritéria pro zařazení:
- Aktivní personál speciálních sil (18-série)
- Schopnost číst a rozumět angličtině pro účely souhlasu
- Schopný zavázat se ke studijní intervenci a sledování
- Schopnost účastnit se školení trenérů THOR3 bez omezení
Kritéria vyloučení:
- Obézní (tělesný tuk > 25 %)
- Kardiovaskulární onemocnění
- Užívání vybraných léků (např. statiny, diuretika, léky na hypertenzi)
- ženský
- Tetování v ošetřované oblasti (část těla)
- Diagnóza porfyrie (alergie vyvolaná světlem) nebo fotosenzitivní ekzém
- Současné užívání léků spojených s citlivostí na teplo nebo světlo (např. amiodaron, chlorpromazin, doxycyklin, hydrochlorothiazid, kyselina nalidixová, naproxen, piroxikam, tetracyklin, thioridazin, vorikonazol)
- Použití kardiostimulátoru / základní srdeční onemocnění
- Diagnostikováno autoimunitním onemocněním
- Albinismus
- Periferní neuropatie
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Singl
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
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Falešný srovnávač: Falešná PBMT
Zahrnutí předstíraného PBMT zajistí, že všechny léčebné postupy účastníků zůstanou stejné, s výjimkou emise fotonů (aktivní léčba), což umožní, aby se případné rozdíly mezi skupinami připsaly k použití PBMT.
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Sham PBMT bude zajišťovat vyškolený člen studijního týmu.
Sham PBMT bude aplikován stejným způsobem, jak je uvedeno pro proces PBMT výše, ale zařízení zůstane v pohotovostním režimu (tj. režim léčby nebude zapnut).
Protože infračervené světlo je pouhým okem neviditelné, jediným viditelným rozdílem mezi léčebným a pohotovostním režimem je přítomnost několika drobných jantarových světel (tato světla svítí během léčebného režimu).
Ostatní jména:
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Aktivní komparátor: 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.
Ostatní jména:
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
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Countermovement Jump (CMJ) Initial Baseline: Concentric Impulse
Časové okno: 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.
Časové okno: 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)
Časové okno: 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
Časové okno: 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
Časové okno: 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.
|
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
Časové okno: 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.
|
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)
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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)
Časové okno: 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
Časové okno: 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
Časové okno: 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.
|
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
Časové okno: 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)
Časové okno: 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
Časové okno: 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
Časové okno: 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.
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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.
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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)
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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)
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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.
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Body Measurements: Body Composition (% Body Fat)
Časové okno: Measured prior to treatment starting at time of enrollment.
|
Biometrics
|
Measured prior to treatment starting at time of enrollment.
|
|
Body Measurements: Height (Inches)
Časové okno: Measured prior to treatment starting at time of enrollment.
|
Biometrics
|
Measured prior to treatment starting at time of enrollment.
|
|
Body Measurements: Weight (Lbs)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: Measured prior to treatment starting at time of enrollment.
|
Biometrics - used to calculate PBMT dosage
|
Measured prior to treatment starting at time of enrollment.
|
Další výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Rozměry těla: výška (cm)
Časové okno: Měřeno před zahájením léčby v době registrace.
|
Biometrie
|
Měřeno před zahájením léčby v době registrace.
|
|
Tělesné míry: Hmotnost (kg/lbs)
Časové okno: Měřeno před zahájením léčby v době registrace.
|
Biometrie
|
Měřeno před zahájením léčby v době registrace.
|
|
Tělesné míry: Složení těla (% tělesného tuku)
Časové okno: Měřeno před zahájením léčby v době registrace.
|
Biometrie
|
Měřeno před zahájením léčby v době registrace.
|
|
Tělesné míry: C1 - proximální obvod stehna (cm)
Časové okno: Měřeno před zahájením léčby v době registrace.
|
Biometrie – používá se k výpočtu dávkování PBMT
|
Měřeno před zahájením léčby v době registrace.
|
|
Tělesné míry: C2 - distální obvod stehna (cm)
Časové okno: Měřeno před zahájením léčby v době registrace.
|
Biometrie – používá se k výpočtu dávkování PBMT
|
Měřeno před zahájením léčby v době registrace.
|
|
Rozměry těla: L1 - délka stehna (cm)
Časové okno: Měřeno před zahájením léčby v době registrace.
|
Biometrie – používá se k výpočtu dávkování PBMT
|
Měřeno před zahájením léčby v době registrace.
|
Spolupracovníci a vyšetřovatelé
Spolupracovníci
Vyšetřovatelé
- Vrchní vyšetřovatel: Tanner Santarelli, DPT, 1st Special Forces Group Tactical Human Optimization, Rapid Rehabilitation and Reconditioning (THOR3)
Publikace a užitečné odkazy
Obecné publikace
- 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.
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Primární dokončení (Aktuální)
Dokončení studie (Aktuální)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Další relevantní podmínky MeSH
Další identifikační čísla studie
- USUHS.2023-126
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
Popis plánu IPD
Formulář počátečního souhlasu (ICF) pro tuto výzkumnou studii uvádí, že neidentifikovaná výzkumná data budou sdílena s MIRROR a USU a budou uchovávána po neomezenou dobu pro možné použití v budoucím výzkumu. Souhlasem s účastí v této výzkumné studii účastníci souhlasí s tím, že nám umožní uchovávat jejich neidentifikovaná výzkumná data po neomezenou dobu pro možné použití v budoucím výzkumu.
Účastníci nebudou mít možnost odmítnout uchovávání jejich deidentifikovaných výzkumných dat na dobu neurčitou pro možné budoucí použití. ICF uvádí: „Pokud si nepřejete, aby vaše deidentifikovaná data shromážděná v rámci této výzkumné studie byla uchována pro použití v budoucích výzkumných studiích, neměli byste tento formulář souhlasu podepisovat.“
Typ podpůrných informací pro sdílení IPD
- PROTOKOL STUDY
- MÍZA
- ICF
- ANALYTIC_CODE
- CSR
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Studuje produkt zařízení regulovaný americkým úřadem FDA
produkt vyrobený a vyvážený z USA
Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .
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