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Photomedizin-Projekt 14: PBMT zur Leistungssteigerung bei SOF (SOF)

18. Mai 2026 aktualisiert von: Musculoskeletal Injury Rehabilitation Research for Operational Readiness

Bewertung der Auswirkungen der Photobiomodulationsanwendung nach dem Training auf Leistung, Erholung und Verhaltenszustand bei geschulten Spezialoperatoren

Special Operations Forces (SOF) trainieren kontinuierlich, um Spitzenleistungen aufrechtzuerhalten. Daher befinden sie sich fast immer in einem Zustand der Genesung und benötigen nicht-invasive Therapien, um die anstrengende Arbeitsbelastung zu bewältigen. Die Photobiomodulationstherapie (PBMT) ist eine nichtinvasive Behandlung, bei der ein Low-Level-Laser auf den Körper angewendet wird, um Heilung, Erholung und Leistungsfähigkeit zu verbessern. Army Tactical Human Optimization Rapid Rehabilitation and Reconditioning (THOR3) bietet einen konsistenten Weg für die Implementierung von PBMT als Modalität. Studien an Sportlern haben gezeigt, dass die gezielte Anwendung von PBMT vor und nach dem Training Leistungs- und Erholungsvorteile bringt. Während es weniger Beweise für die potenziellen kognitiven/verhaltensbezogenen Auswirkungen einer systematischen Anwendung von PBMT gibt, wurde auch festgestellt, dass die selbstberichtete Müdigkeit in Gruppen mit fokaler PBMT-Anwendung im Vergleich zu Placebo signifikant geringer war. Darüber hinaus ist die PBMT-Forschung an gesunden taktischen Militärsportlern begrenzt. PBMT könnte ein vielversprechendes Instrument zur Verbesserung der körperlichen Leistungsfähigkeit sein, indem es die muskuloskelettale und psychische Erholung in der SOF-Population beschleunigt. Ziel der Forscher ist es, die physiologischen und verhaltensbezogenen Auswirkungen der PBMT-Anwendung nach dem Training auf die Leistung von SOF-Betreibern zu untersuchen.

Die Absicht: Die Forscher schlagen vor, eine einfach verblindete randomisierte Kontrollstudie mit Scheinkontrolle durchzuführen, um die Wirksamkeit der Bereitstellung von PBMT nach körperlichem Training in einer SOF-Population zu untersuchen.

Die spezifischen Ziele dieser Studie sind:

  1. Analysieren und beschreiben Sie gegebenenfalls die physiologischen Auswirkungen der PBMT-Anwendung nach dem Training bei Spezialkräften, die eine von Trainern geleitete Ausbildung absolvieren.
  2. Analysieren und beschreiben Sie gegebenenfalls die Verhaltenseffekte der PBMT-Anwendung nach dem Training bei Spezialkräften, die eine von Trainern geleitete Ausbildung absolvieren.
  3. Bewerten Sie den gesamten klinischen Nutzen der fokalen PBMT im Anschluss an das körperliche Training in einer SOF-Gruppe taktischer Athleten der US-Armee.

Studienübersicht

Status

Abgeschlossen

Bedingungen

Intervention / Behandlung

Studientyp

Interventionell

Einschreibung (Tatsächlich)

29

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

  • Vereinigte Staaten
    • Washington
      • Joint Base Lewis McChord, Washington, Vereinigte Staaten, 98433
        • Joint Base Lewis-McChord

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Erwachsene

Akzeptiert gesunde Freiwillige

Ja

Beschreibung

Einschlusskriterien:

  • Aktives Personal der Spezialeinheiten (Serie 18)
  • Kann die englische Sprache zum Zweck der Einwilligung lesen und verstehen
  • Kann sich für Studieninterventionen und Nachuntersuchungen engagieren
  • Kann ohne Einschränkung am THOR3-Coach-Lead-Training teilnehmen

Ausschlusskriterien:

  • Fettleibig (Körperfett > 25 %)
  • Herzkreislauferkrankung
  • Verwendung ausgewählter Medikamente (z. B. Statine, Diuretika, blutdrucksenkende Mittel)
  • Weiblich
  • Tätowierung im Behandlungsbereich (Körperregion)
  • Diagnose: Porphyrie (lichtinduzierte Allergie) oder lichtempfindliches Ekzem
  • Aktuelle Einnahme von Medikamenten, die mit Hitze- oder Lichtempfindlichkeit einhergehen (z. B. Amiodaron, Chlorpromazin, Doxycyclin, Hydrochlorothiazid, Nalidixinsäure, Naproxen, Piroxicam, Tetracyclin, Thioridazin, Voriconazol)
  • Verwendung eines Herzschrittmachers/vorliegende Herzerkrankung
  • Bei Ihnen wurde eine Autoimmunerkrankung diagnostiziert.
  • Albinismus
  • Periphere Neuropathie

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Single

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Schein-Komparator: Schein-PBMT
Durch die Einbeziehung von Schein-PBMT wird sichergestellt, dass alle Behandlungsverfahren der Teilnehmer gleich bleiben, mit Ausnahme der Emission von Photonen (aktive Behandlung), sodass etwaige Unterschiede zwischen Gruppen auf die Verwendung von PBMT zurückgeführt werden können.
Gerät: THOR3-Training + Schein-PBMT
Schein-PBMT wird von einem geschulten Mitglied des Studienteams durchgeführt. Die Schein-PBMT wird auf die gleiche Weise wie oben für den PBMT-Prozess angegeben durchgeführt, das Gerät bleibt jedoch im Standby-Modus (d. h. der Behandlungsmodus wird nicht eingeschaltet). Da Infrarotlicht für das bloße Auge unsichtbar ist, besteht der einzige sichtbare Unterschied zwischen Behandlungs- und Standby-Modus im Vorhandensein einiger winziger bernsteinfarbener Lichter (diese Lichter leuchten im Behandlungsmodus).
Andere Namen:
  • THOR3-Training + Placebo
Aktiver 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.
Gerät: THOR3 training + Photobiomodulation Therapy (PBMT)

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.

Andere Namen:
  • Low-Level-Lasertherapie (LLLT)
  • LightForce® XLi

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Countermovement Jump (CMJ) Initial Baseline: Concentric Impulse
Zeitfenster: 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.
Zeitfenster: 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)
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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)
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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)
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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)
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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.
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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.
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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)
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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)
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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.

Sekundäre Ergebnismessungen

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

Andere Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Körpermaße: Größe (cm)
Zeitfenster: Gemessen vor Beginn der Behandlung zum Zeitpunkt der Einschreibung.
Biometrie
Gemessen vor Beginn der Behandlung zum Zeitpunkt der Einschreibung.
Körpermaße: Gewicht (kg/lbs)
Zeitfenster: Gemessen vor Beginn der Behandlung zum Zeitpunkt der Einschreibung.
Biometrie
Gemessen vor Beginn der Behandlung zum Zeitpunkt der Einschreibung.
Körpermaße: Körperzusammensetzung (% Körperfett)
Zeitfenster: Gemessen vor Beginn der Behandlung zum Zeitpunkt der Einschreibung.
Biometrie
Gemessen vor Beginn der Behandlung zum Zeitpunkt der Einschreibung.
Körpermaße: C1 – proximaler Oberschenkelumfang (cm)
Zeitfenster: Gemessen vor Beginn der Behandlung zum Zeitpunkt der Einschreibung.
Biometrie – wird zur Berechnung der PBMT-Dosierung verwendet
Gemessen vor Beginn der Behandlung zum Zeitpunkt der Einschreibung.
Körpermaße: C2 – distaler Oberschenkelumfang (cm)
Zeitfenster: Gemessen vor Beginn der Behandlung zum Zeitpunkt der Einschreibung.
Biometrie – wird zur Berechnung der PBMT-Dosierung verwendet
Gemessen vor Beginn der Behandlung zum Zeitpunkt der Einschreibung.
Körpermaße: L1 – Oberschenkellänge (cm)
Zeitfenster: Gemessen vor Beginn der Behandlung zum Zeitpunkt der Einschreibung.
Biometrie – wird zur Berechnung der PBMT-Dosierung verwendet
Gemessen vor Beginn der Behandlung zum Zeitpunkt der Einschreibung.

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Musculoskeletal Injury Rehabilitation Research for Operational Readiness

Mitarbeiter

Uniformed Services University of the Health Sciences
The Geneva Foundation
1st Special Forces Group (Airborne), United States Army
United States Army Special Operations Command

Ermittler

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

Publikationen und hilfreiche Links

Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.

Allgemeine Veröffentlichungen

Nützliche Links

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Tatsächlich)

23. Januar 2025

Primärer Abschluss (Tatsächlich)

2. März 2026

Studienabschluss (Tatsächlich)

2. März 2026

Studienanmeldedaten

Zuerst eingereicht

13. März 2024

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

18. April 2024

Zuerst gepostet (Tatsächlich)

23. April 2024

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

15. Juni 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

18. Mai 2026

Zuletzt verifiziert

1. Mai 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • USUHS.2023-126

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

JA

Beschreibung des IPD-Plans

Das Initial Consent Form (ICF) für diese Forschungsstudie besagt, dass anonymisierte Forschungsdaten an MIRROR und USU weitergegeben und auf unbestimmte Zeit für eine mögliche Verwendung in zukünftigen Forschungen aufbewahrt werden. Durch die Zustimmung zur Teilnahme an dieser Forschungsstudie erklären sich die Teilnehmer damit einverstanden, dass wir ihre anonymisierten Forschungsdaten für eine mögliche Verwendung in zukünftigen Forschungen auf unbestimmte Zeit aufbewahren.

Den Teilnehmern wird nicht die Möglichkeit eingeräumt, der Speicherung ihrer anonymisierten Forschungsdaten durch uns für eine mögliche zukünftige Verwendung auf unbestimmte Zeit zu widersprechen. Das ICF erklärt: „Wenn Sie nicht möchten, dass Ihre im Rahmen dieser Forschungsstudie gesammelten anonymisierten Daten für die Verwendung in zukünftigen Forschungsstudien aufbewahrt werden, sollten Sie dieses Einverständnisformular nicht unterzeichnen.“

Art der unterstützenden IPD-Freigabeinformationen

  • STUDIENPROTOKOLL
  • SAFT
  • ICF
  • ANALYTIC_CODE
  • CSR

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Ja

Produkt, das in den USA hergestellt und aus den USA exportiert wird

Ja

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

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Bedingungen

Seltene Krankheiten

Drogeninterventionen

Nahrungsergänzungsmittel

Sponsor / Mitarbeiter

Standorte

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