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Fotomedicinsk projekt 14: PBMT for Performance Enhancement i SOF (SOF)

Vurdering af virkningen af ​​fotobiomodulationsapplikation efter træning på ydeevne, restitution og adfærdstilstand i uddannet specialoperatørpopulation

Special Operations Forces (SOF) træner konstant for at opretholde toppræstationer. De er således næsten altid i en tilstand af bedring og har behov for ikke-invasive terapier for at løse den belastende arbejdsbyrde. Fotobiomodulationsterapi (PBMT) er en ikke-invasiv behandling, hvor en lav-niveau laser påføres kroppen for at forbedre heling, restitution og ydeevne. Army Tactical Human Optimization Rapid Rehabilitation and Reconditioning (THOR3) giver en konsekvent mulighed for implementering af PBMT som en modalitet. Undersøgelser af atleter har vist præstations- og restitutionsfordele med fokal anvendelse af PBMT før og efter træning. Mens der er mindre evidens for de potentielle kognitive/adfærdsmæssige virkninger af en systematisk anvendelse af PBMT, har selvrapporteret træthed også vist sig at være signifikant lavere i grupper med fokal PBMT-anvendelse sammenlignet med placebo. Yderligere er PBMT-forskning i raske militære taktiske atleter begrænset. PBMT kan være et lovende værktøj til at forbedre den fysiske præstation ved at accelerere muskuloskeletal og psykologisk restitution i SOF-befolkningen. Efterforskerne sigter mod at studere de fysiologiske og adfærdsmæssige virkninger af PBMT-applikation efter træning på præstation hos SOF-operatører.

Hensigten: Efterforskerne foreslår at udføre et enkelt-blindet randomiseret kontrolforsøg med falsk kontrol for at undersøge effektiviteten af ​​at give PBMT efter fysisk træning i en SOF-population.

De specifikke mål med denne undersøgelse er at:

  1. Analyser og beskriv de fysiologiske virkninger, hvis nogen, af PBMT-anvendelse efter træning i specialstyrkeoperatører, der gennemgår coach-ledet træning.
  2. Analyser og beskriv de adfærdsmæssige virkninger, hvis nogen, af PBMT-anvendelse efter træning i specialstyrkeoperatører, der gennemgår coach-ledet træning.
  3. Evaluer den overordnede kliniske nytte af fokal PBMT efter fysisk træning i en US Army SOF, taktisk atletpopulation.

Studieoversigt

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

29

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

    • Washington
      • Joint Base Lewis McChord, Washington, Forenede Stater, 98433
        • Joint Base Lewis-McChord

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen

Tager imod sunde frivillige

Ja

Beskrivelse

Inklusionskriterier:

  • Active-Duty Special Forces Personale (18-serie)
  • Kunne læse og forstå engelsk til samtykkeformål
  • Kunne forpligte sig til studieintervention og opfølgning
  • Kunne deltage i THOR3 coach-lead træning, uden begrænsning

Ekskluderingskriterier:

  • Overvægtig (kropsfedt > 25 %)
  • Kardiovaskulær sygdom
  • Brug af udvalgte lægemidler (f.eks. statiner, diuretika, hypertensive midler)
  • Kvinde
  • Tatovering i behandlingsområde (kropsregion)
  • Diagnose med porfyri (lysinduceret allergi) eller lysfølsomt eksem
  • Nuværende brug af medicin forbundet med følsomhed over for varme eller lys (f.eks. amiodaron, chlorpromazin, doxycyclin, hydrochlorthiazid, nalidixinsyre, naproxen, piroxicam, tetracyclin, thioridazin, voriconazol)
  • Brug af pacemaker/underliggende hjertesygdom
  • Diagnosticeret med autoimmune sygdomme
  • Albinisme
  • Perifer neuropati

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Sham-komparator: Sham PBMT
Inkluderingen af ​​sham PBMT vil sikre, at alle deltagerbehandlingsprocedurer forbliver de samme, med undtagelse af emission af fotoner (aktiv behandling), hvilket giver mulighed for bidrag af eventuelle forskelle mellem grupper, der kan krediteres brugen af ​​PBMT.
Sham PBMT vil blive leveret af et uddannet studieteammedlem. Sham PBMT vil blive leveret på samme måde som angivet for PBMT-processen ovenfor, men enheden forbliver i standbytilstand (dvs. behandlingstilstanden vil ikke være aktiveret). Da infrarødt lys er usynligt for det blotte øje, er den eneste synlige forskel mellem behandlings- og standbytilstand tilstedeværelsen af ​​et par små ravgule lys (disse lys er tændt under behandlingstilstand).
Andre navne:
  • THOR3 træning + placebo
Aktiv komparator: Photobiomodulation Treatment (PBMT)
PBMT will be delivered at 40 watts (W). PBMT will be applied to the quadriceps area. A study team member will use the quadriceps measurements of the treatment area to calculate the PBMT treatment time (approximately 5-20 minutes) and specified J/cm2. PBMT treatment will be provided 3 times per week, for 3 weeks.

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.

Andre navne:
  • Laserterapi på lavt niveau (LLLT)
  • LightForce® XLi

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Countermovement Jump (CMJ) Initial Baseline: Concentric Impulse
Tidsramme: 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.
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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.
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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.
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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.

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Body Measurements: Body Composition (% Body Fat)
Tidsramme: Measured prior to treatment starting at time of enrollment.
Biometrics
Measured prior to treatment starting at time of enrollment.
Body Measurements: Height (Inches)
Tidsramme: Measured prior to treatment starting at time of enrollment.
Biometrics
Measured prior to treatment starting at time of enrollment.
Body Measurements: Weight (Lbs)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: Measured prior to treatment starting at time of enrollment.
Biometrics - used to calculate PBMT dosage
Measured prior to treatment starting at time of enrollment.

Andre resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Kropsmål: Højde (cm)
Tidsramme: Målt før behandling starter på tidspunktet for indskrivning.
Biometri
Målt før behandling starter på tidspunktet for indskrivning.
Kropsmål: Vægt (kg/lbs)
Tidsramme: Målt før behandling starter på tidspunktet for indskrivning.
Biometri
Målt før behandling starter på tidspunktet for indskrivning.
Kropsmålinger: Kropssammensætning (% kropsfedt)
Tidsramme: Målt før behandling starter på tidspunktet for indskrivning.
Biometri
Målt før behandling starter på tidspunktet for indskrivning.
Kropsmål: C1 - proksimal låromkreds (cm)
Tidsramme: Målt før behandling starter på tidspunktet for indskrivning.
Biometri - bruges til at beregne PBMT-dosering
Målt før behandling starter på tidspunktet for indskrivning.
Kropsmål: C2 - distal låromkreds (cm)
Tidsramme: Målt før behandling starter på tidspunktet for indskrivning.
Biometri - bruges til at beregne PBMT-dosering
Målt før behandling starter på tidspunktet for indskrivning.
Kropsmål: L1 - lårlængde (cm)
Tidsramme: Målt før behandling starter på tidspunktet for indskrivning.
Biometri - bruges til at beregne PBMT-dosering
Målt før behandling starter på tidspunktet for indskrivning.

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Efterforskere

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

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

23. januar 2025

Primær færdiggørelse (Faktiske)

2. marts 2026

Studieafslutning (Faktiske)

2. marts 2026

Datoer for studieregistrering

Først indsendt

13. marts 2024

Først indsendt, der opfyldte QC-kriterier

18. april 2024

Først opslået (Faktiske)

23. april 2024

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

15. juni 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

18. maj 2026

Sidst verificeret

1. maj 2026

Mere information

Begreber relateret til denne undersøgelse

Andre undersøgelses-id-numre

  • USUHS.2023-126

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

JA

IPD-planbeskrivelse

I Initial Consent Form (ICF) for denne forskningsundersøgelse står der, at afidentificerede forskningsdata vil blive delt med MIRROR og USU og opbevaret på ubestemt tid til mulig brug i fremtidig forskning. Ved at give samtykke til at deltage i denne forskningsundersøgelse, accepterer deltagerne at tillade os at bevare deres afidentificerede forskningsdata på ubestemt tid til mulig brug i fremtidig forskning.

Deltagerne vil ikke få mulighed for at fravælge, at vi beholder deres afidentificerede forskningsdata på ubestemt tid til mulig fremtidig brug. ICF udtaler: "Hvis du ikke ønsker, at dine afidentificerede data indsamlet som en del af denne forskningsundersøgelse skal opbevares til brug i fremtidige forskningsundersøgelser, bør du ikke underskrive denne samtykkeerklæring."

IPD-deling Understøttende informationstype

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ja

produkt fremstillet i og eksporteret fra U.S.A.

Ja

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med THOR3 træning + sham PBMT

3
Abonner