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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:

  1. Analyzujte a popište případné fyziologické účinky aplikace PBMT po cvičení u operátorů speciálních sil, kteří podstupují výcvik vedený trenérem.
  2. Analyzujte a popište případné behaviorální účinky aplikace PBMT po cvičení u operátorů speciálních sil, kteří procházejí školením vedeným trenérem.
  3. Vyhodnoťte celkovou klinickou užitečnost fokální PBMT po fyzickém tréninku v populaci taktických sportovců US Army SOF.

Přehled studie

Typ studie

Intervenční

Zápis (Aktuální)

29

Fáze

  • Nelze použít

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní místa

    • Washington
      • Joint Base Lewis McChord, Washington, Spojené státy, 98433
        • Joint Base Lewis-McChord

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

  • Dospělý

Přijímá zdravé dobrovolníky

Ano

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

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

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
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.
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:
  • Trénink THOR3 + placebo
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.

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:
  • Nízkoúrovňová laserová terapie (LLLT)
  • LightForce® XLi

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Countermovement Jump (CMJ) Initial Baseline: Concentric Impulse
Časové okno: Collected prior to treatment starting at time of enrollment.
Assesses dynamic strength performance, including concentric impulse via force plates and analysis software.
Collected prior to treatment starting at time of enrollment.
Countermovement Jump (CMJ) Initial Baseline: Movement Start to Peak Power.
Časové okno: Collected prior to treatment starting at time of enrollment.
Assesses dynamic strength performance, including Movement start to peak power. via force plates and analysis software.
Collected prior to treatment starting at time of enrollment.
Countermovement Jump (CMJ) Initial Baseline: Reactive Strength Index-modified (RSImod)
Časové okno: Collected prior to treatment starting at time of enrollment.

Assesses dynamic strength performance, including Reactive Strength Index-modified (RSImod) via force plates and analysis software. Reactive Strength Index-modified (RSImod) reflects the efficiency of force production during a countermovement jump. It is calculated as jump height divided by time to take-off. Higher values indicate better explosive performance and lower neuromuscular fatigue, whereas lower values indicate reduced efficiency or increased fatigue. The index ranges from 0 upward with no theoretical maximum; therefore, interpretation should rely on normative ranges or athlete-specific baselines.

Reference categories:

Lower performers (L): ~0.20-0.30

Moderate performers (M): ~0.30-0.45

Upper performers (U): ~0.45-0.70+

Collected prior to treatment starting at time of enrollment.
Countermovement Jump (CMJ) Initial Baseline: Time to Take-Off
Časové okno: Collected prior to treatment starting at time of enrollment.
Assesses dynamic strength performance, including Time to Take-Off via force plates and analysis software.
Collected prior to treatment starting at time of enrollment.
Countermovement Jump (CMJ) Week 1 Follow-up: Concentric Impulse
Časové okno: Collected at the end of week 1 prior to coach-led training.
Assesses dynamic strength performance, including concentric impulse via force plates and analysis software.
Collected at the end of week 1 prior to coach-led training.
Countermovement Jump (CMJ) Week 1 Follow-up: Movement Start to Peak Power
Časové okno: Collected at the end of week 1 prior to coach-led training.
Assesses dynamic strength performance, including Movement Start to peak Power via force plates and analysis software.
Collected at the end of week 1 prior to coach-led training.
Countermovement Jump (CMJ) Week 1 Follow-up: Reactive Strength Index-modified (RSImod)
Časové okno: Collected at the end of week 1 prior to coach-led training.

Assesses dynamic strength performance, including Reactive Strength Index-modified (RSImod) via force plates and analysis software. Reactive Strength Index-modified (RSImod) reflects the efficiency of force production during a countermovement jump. It is calculated as jump height divided by time to take-off. Higher values indicate better explosive performance and lower neuromuscular fatigue, whereas lower values indicate reduced efficiency or increased fatigue. The index ranges from 0 upward with no theoretical maximum; therefore, interpretation should rely on normative ranges or athlete-specific baselines.

Reference categories:

Lower performers (L): ~0.20-0.30

Moderate performers (M): ~0.30-0.45

Upper performers (U): ~0.45-0.70+

Collected at the end of week 1 prior to coach-led training.
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.
Assesses dynamic strength performance, including Time to Take-Off via force plates and analysis software.
Collected at the end of week 1 prior to coach-led training.
Countermovement Jump (CMJ) Week 2 Follow-up: Concentric Impulse
Časové okno: Collected at the end of week 2 prior to coach-led training.
Assesses dynamic strength performance, including concentric impulse via force plates and analysis software.
Collected at the end of week 2 prior to coach-led training.
Countermovement Jump (CMJ) Week 2 Follow-up: Movement Start to Peak Power
Časové okno: Collected at the end of week 2 prior to coach-led training.
Assesses dynamic strength performance, including peak force production via force plates and analysis software.
Collected at the end of week 2 prior to coach-led training.
Countermovement Jump (CMJ) Week 2 Follow-up: Reactive Strength Index-modified (RSImod)
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.
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.
Assesses dynamic strength performance, including Time to Take-Off via force plates and analysis software.
Collected at the end of week 2 prior to coach-led training.
Countermovement Jump (CMJ) Week 3 Follow-up: Concentric Impulse
Časové okno: Collected at the end of week 3 prior to coach-led training.
Assesses dynamic strength performance, including concentric impulse via force plates and analysis software.
Collected at the end of week 3 prior to coach-led training.
Countermovement Jump (CMJ) Week 3 Follow-up: Movement Start to Peak Power
Časové okno: Collected at the end of week 3 prior to coach-led training.
Assesses dynamic strength performance, including peak force production via force plates and analysis software.
Collected at the end of week 3 prior to coach-led training.
Countermovement Jump (CMJ) Week 3 Follow-up: Reactive Strength Index-modified (RSImod)
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.
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.
Assesses dynamic strength performance, including Time to Take-Off via force plates and analysis software.
Collected at the end of week 3 prior to coach-led training.
Isometric Quadriceps Strength Testing Initial Baseline: Peak Torque
Časové okno: Collected prior to treatment starting at time of enrollment.
Measuring isolated strength (Peak Torque).
Collected prior to treatment starting at time of enrollment.
Isometric Hamstrings Strength Testing Initial Baseline: Peak Torque.
Časové okno: Collected prior to treatment starting at time of enrollment.
Measuring isolated strength (Peak Torque).
Collected prior to treatment starting at time of enrollment.
Isokinetic Quadriceps Strength Testing Initial Baseline: Peak Torque
Časové okno: Collected prior to treatment starting at time of enrollment.
Measuring isolated strength (Peak Torque).
Collected prior to treatment starting at time of enrollment.
Isokinetic Hamstrings Strength Testing Initial Baseline: Peak Torque
Časové okno: Collected prior to treatment starting at time of enrollment.
Measuring isolated strength (Peak Torque).
Collected prior to treatment starting at time of enrollment.
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.
Measuring isolated strength (Peak Torque).
Collected at the 3-week follow-up session prior to coach-led training.
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.
Measuring isolated strength (Peak Torque).
Collected at the 3-week follow-up session prior to coach-led training.
Isokinetic Quadriceps Strength Testing 3-week Follow-up: Peak Torque
Časové okno: Collected at the 3-week follow-up session prior to coach-led training.
Measuring isolated strength (Peak Torque).
Collected at the 3-week follow-up session prior to coach-led training.
Isokinetic Hamstrings Strength Testing 3-week Follow-up: Peak Torque
Časové okno: Collected at the 3-week follow-up session prior to coach-led training.
Measuring isolated strength (Peak Torque).
Collected at the 3-week follow-up session prior to coach-led training.
Defense and Veteran's Pain Rating Scale (DVPRS) Initial Baseline
Časové okno: Self-reported at baseline
Captures subjective pain rating on a 0 - 10 scale (minimum - maximum; 0 = no pain, 10 = severe pain). Higher scores equal worse outcomes.
Self-reported at baseline
Defense and Veteran's Pain Rating Scale (DVPRS) Daily Reports
Časové okno: Self-reported, daily after baseline through study completion after 3 weeks.
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.
Self-reported, daily after baseline through study completion after 3 weeks.
Visual Analog Scale (VAS) Initial Baseline
Časové okno: Collected prior to treatment starting at time of enrollment.
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.
Collected prior to treatment starting at time of enrollment.
Visual Analog Scale (VAS) Week 1 Follow-up
Časové okno: Collected at the end of week 1 after coach-led training and laser treatment.
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.
Collected at the end of week 1 after coach-led training and laser treatment.
Visual Analog Scale (VAS) Week 2 Follow-up
Časové okno: Collected at the end of week 2 after coach-led training and laser treatment.
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.
Collected at the end of week 2 after coach-led training and laser treatment.
Visual Analog Scale (VAS) Week 3 Follow-up
Časové okno: Collected at the end of week 3 after coach-led training and laser treatment.
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.
Collected at the end of week 3 after coach-led training and laser treatment.
Borg Modified Rating of Perceived Exertion (RPE) Initial Baseline
Časové okno: Collected prior to treatment starting at time of enrollment
Quantifying perceived exertion on 0-10 scale. Higher scores indicate worse outcomes.
Collected prior to treatment starting at time of enrollment
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.
Quantifying perceived exertion on 0-10 scale. Higher scores indicate worse outcomes.
Collected at the 3-week follow-up session after coach-led training and laser treatment.
Elloumi Fatigue Scale Initial Baseline
Časové okno: Collected prior to treatment starting at time of enrollment.
Behavioral health rating of fatigue. The short questionnaire of fatigue uses eight questions that highlight perception of training difficulty, sleep, leg discomfort, infection/colds, concentration, work efficacy, anxiety and overall stress. Each question is rated by the respondent on a 7-point scale: 1 point (not at all) to 7 points (very much). The summed total score of the 8 questions allows for a total score of fatigue (TSF). Total score of fatigue ranges from 8 points (not at all fatigued) to 56 points (very much fatigued).
Collected prior to treatment starting at time of enrollment.
Elloumi Fatigue Scale 3-week Follow-up
Časové okno: Collected at the 3-week follow-up session after coach-led training and laser treatment.
Behavioral health rating of fatigue. The short questionnaire of fatigue uses eight questions that highlight perception of training difficulty, sleep, leg discomfort, infection/colds, concentration, work efficacy, anxiety and overall stress. Each question is rated by the respondent on a 7-point scale: 1 point (not at all) to 7 points (very much). The summed total score of the 8 questions allows for a total score of fatigue (TSF). Total score of fatigue ranges from 8 points (not at all fatigued) to 56 points (very much fatigued).
Collected at the 3-week follow-up session after coach-led training and laser treatment.
Quick Physical Activity Rating Scale (QPAR)
Časové okno: Collected prior to treatment starting at time of enrollment.
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.
Collected prior to treatment starting at time of enrollment.
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.
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.
Oura data is collected from daily wear of ring from date of randomization through study completion after 3 weeks.
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.
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.
Oura data is collected from daily wear of ring from date of randomization through study completion after 3 weeks.
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.
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.
Oura data is collected from daily wear of ring from date of randomization through study completion after 3 weeks.
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.
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.
Oura data is collected from daily wear of ring from date of randomization through study completion after 3 weeks.
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.
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.
Oura data is collected from daily wear of ring from date of randomization through study completion after 3 weeks.
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.
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.
Oura data is collected from daily wear of ring from date of randomization through study completion after 3 weeks.
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.
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.
Oura data is collected from daily wear of ring from date of randomization through study completion after 3 weeks.
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.
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.
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 - Body Temperature Changes
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 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
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 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)
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 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
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

Zde najdete lidi a organizace zapojené do této studie.

Vyšetřovatelé

  • Vrchní vyšetřovatel: Tanner Santarelli, DPT, 1st Special Forces Group Tactical Human Optimization, Rapid Rehabilitation and Reconditioning (THOR3)

Publikace a užitečné odkazy

Osoba odpovědná za zadávání informací o studiu tyto publikace poskytuje dobrovolně. Mohou se týkat čehokoli, co souvisí se studiem.

Obecné publikace

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Aktuální)

23. ledna 2025

Primární dokončení (Aktuální)

2. března 2026

Dokončení studie (Aktuální)

2. března 2026

Termíny zápisu do studia

První předloženo

13. března 2024

První předloženo, které splnilo kritéria kontroly kvality

18. dubna 2024

První zveřejněno (Aktuální)

23. dubna 2024

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

15. června 2026

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

18. května 2026

Naposledy ověřeno

1. května 2026

Více informací

Termíny související s touto studií

Další identifikační čísla studie

  • USUHS.2023-126

Plán pro data jednotlivých účastníků (IPD)

Plánujete sdílet data jednotlivých účastníků (IPD)?

ANO

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

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Studuje produkt zařízení regulovaný americkým úřadem FDA

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produkt vyrobený a vyvážený z USA

Ano

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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