Proyecto de fotomedicina 14: PBMT para mejorar el rendimiento en SOF (SOF)
18 de mayo de 2026 actualizado por: Musculoskeletal Injury Rehabilitation Research for Operational Readiness
Evaluación del impacto de la aplicación de fotobiomodulación posterior al ejercicio en el rendimiento, la recuperación y el estado de comportamiento en una población de operadores especiales capacitados
Las Fuerzas de Operaciones Especiales (SOF) se entrenan continuamente para mantener el máximo rendimiento. Por lo tanto, casi siempre se encuentran en estado de recuperación y necesitan terapias no invasivas para hacer frente a la agotadora carga de trabajo. La terapia de fotobiomodulación (PBMT) es un tratamiento no invasivo en el que se aplica un láser de baja intensidad al cuerpo para mejorar la curación, la recuperación y el rendimiento. La rehabilitación y el reacondicionamiento rápidos de optimización humana táctica del ejército (THOR3) proporcionan una vía consistente para la implementación de PBMT como modalidad. Los estudios en atletas han demostrado beneficios en el rendimiento y la recuperación con la aplicación focal de PBMT antes y después del entrenamiento. Si bien hay menos evidencia sobre los posibles efectos cognitivos/conductuales de una aplicación sistemática de PBMT, también se ha descubierto que la fatiga autoinformada es significativamente menor en los grupos con aplicación focal de PBMT en comparación con el placebo. Además, la investigación de PBMT en atletas tácticos militares sanos es limitada. PBMT puede ser una herramienta prometedora para mejorar el rendimiento físico al acelerar la recuperación musculoesquelética y psicológica en la población SOF. Los investigadores tienen como objetivo estudiar los efectos fisiológicos y conductuales de la aplicación de PBMT después del ejercicio sobre el rendimiento en operadores SOF.
La intención: Los investigadores proponen realizar un ensayo de control aleatorio simple ciego con control simulado para investigar la eficacia de proporcionar PBMT después del entrenamiento físico en una población SOF.
Los objetivos específicos de este estudio son:
- Analizar y describir los efectos fisiológicos, si los hay, de la aplicación de PBMT después del ejercicio en operadores de fuerzas especiales que reciben entrenamiento dirigido por un entrenador.
- Analizar y describir los efectos conductuales, si los hubiera, de la aplicación de PBMT después del ejercicio en operadores de fuerzas especiales que reciben capacitación dirigida por un entrenador.
- Evaluar la utilidad clínica general del PBMT focal posterior al entrenamiento físico en una población de atletas tácticos SOF del Ejército de EE. UU.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Intervencionista
Inscripción (Actual)
29
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
-
-
Washington
-
Joint Base Lewis McChord, Washington, Estados Unidos, 98433
- Joint Base Lewis-McChord
-
-
Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
Acepta Voluntarios Saludables
Sí
Descripción
Criterios de inclusión:
- Personal de fuerzas especiales en servicio activo (serie 18)
- Capaz de leer y comprender el idioma inglés para fines de consentimiento.
- Capaz de comprometerse con la intervención y el seguimiento del estudio.
- Capaz de participar en el entrenamiento dirigido por un entrenador de THOR3, sin restricciones.
Criterio de exclusión:
- Obesidad (grasa corporal > 25%)
- Enfermedad cardiovascular
- Uso de medicamentos seleccionados (p. ej., estatinas, diuréticos, agentes hipertensivos)
- Femenino
- Tatuaje en zona de tratamiento (región del cuerpo)
- Diagnóstico de porfiria (alergia inducida por la luz) o eczema fotosensible
- Uso actual de medicamentos asociados con sensibilidad al calor o a la luz (p. ej., amiodarona, clorpromazina, doxiciclina, hidroclorotiazida, ácido nalidíxico, naproxeno, piroxicam, tetraciclina, tioridazina, voriconazol)
- Uso de marcapasos/enfermedad cardíaca subyacente
- Diagnosticado con enfermedades autoinmunes
- Albinismo
- Neuropatía periférica
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Comparador falso: PBMT falso
La inclusión de PBMT simulado garantizará que todos los procedimientos de tratamiento de los participantes sigan siendo los mismos, con la excepción de la emisión de fotones (tratamiento activo), permitiendo así que la contribución de cualquier diferencia entre grupos se acredite al uso de PBMT.
|
El PBMT simulado será proporcionado por un miembro capacitado del equipo de estudio.
El PBMT simulado se administrará de la misma manera que se indica para el proceso PBMT anterior, pero el dispositivo permanecerá en modo de espera (es decir, el modo de tratamiento no se activará).
Como la luz infrarroja es invisible a simple vista, la única diferencia visible entre los modos de tratamiento y de espera es la presencia de unas pocas luces ámbar diminutas (estas luces están encendidas durante el modo de tratamiento).
Otros nombres:
|
|
Comparador activo: 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.
Otros nombres:
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Countermovement Jump (CMJ) Initial Baseline: Concentric Impulse
Periodo de tiempo: 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.
Periodo de tiempo: 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)
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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)
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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)
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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)
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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.
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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.
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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)
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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)
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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.
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Body Measurements: Body Composition (% Body Fat)
Periodo de tiempo: Measured prior to treatment starting at time of enrollment.
|
Biometrics
|
Measured prior to treatment starting at time of enrollment.
|
|
Body Measurements: Height (Inches)
Periodo de tiempo: Measured prior to treatment starting at time of enrollment.
|
Biometrics
|
Measured prior to treatment starting at time of enrollment.
|
|
Body Measurements: Weight (Lbs)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: Measured prior to treatment starting at time of enrollment.
|
Biometrics - used to calculate PBMT dosage
|
Measured prior to treatment starting at time of enrollment.
|
Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Medidas del cuerpo: Altura (cm)
Periodo de tiempo: Medido antes del tratamiento a partir del momento de la inscripción.
|
Biometría
|
Medido antes del tratamiento a partir del momento de la inscripción.
|
|
Medidas corporales: Peso (kg/lbs)
Periodo de tiempo: Medido antes del tratamiento a partir del momento de la inscripción.
|
Biometría
|
Medido antes del tratamiento a partir del momento de la inscripción.
|
|
Medidas corporales: Composición corporal (% de grasa corporal)
Periodo de tiempo: Medido antes del tratamiento a partir del momento de la inscripción.
|
Biometría
|
Medido antes del tratamiento a partir del momento de la inscripción.
|
|
Medidas corporales: C1 - circunferencia proximal del muslo (cm)
Periodo de tiempo: Medido antes del tratamiento a partir del momento de la inscripción.
|
Biometría: utilizada para calcular la dosis de PBMT
|
Medido antes del tratamiento a partir del momento de la inscripción.
|
|
Medidas corporales: C2 - circunferencia distal del muslo (cm)
Periodo de tiempo: Medido antes del tratamiento a partir del momento de la inscripción.
|
Biometría: utilizada para calcular la dosis de PBMT
|
Medido antes del tratamiento a partir del momento de la inscripción.
|
|
Medidas del cuerpo: L1 - longitud del muslo (cm)
Periodo de tiempo: Medido antes del tratamiento a partir del momento de la inscripción.
|
Biometría: utilizada para calcular la dosis de PBMT
|
Medido antes del tratamiento a partir del momento de la inscripción.
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Colaboradores
Investigadores
- Investigador principal: Tanner Santarelli, DPT, 1st Special Forces Group Tactical Human Optimization, Rapid Rehabilitation and Reconditioning (THOR3)
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Publicaciones Generales
- Ferraresi C, Dos Santos RV, Marques G, Zangrande M, Leonaldo R, Hamblin MR, Bagnato VS, Parizotto NA. Light-emitting diode therapy (LEDT) before matches prevents increase in creatine kinase with a light dose response in volleyball players. Lasers Med Sci. 2015 May;30(4):1281-7. doi: 10.1007/s10103-015-1728-3. Epub 2015 Feb 27.
- Pinto HD, Vanin AA, Miranda EF, Tomazoni SS, Johnson DS, Albuquerque-Pontes GM, Aleixo IO Junior, Grandinetti VD, Casalechi HL, de Carvalho PT, Leal-Junior EC. Photobiomodulation Therapy Improves Performance and Accelerates Recovery of High-Level Rugby Players in Field Test: A Randomized, Crossover, Double-Blind, Placebo-Controlled Clinical Study. J Strength Cond Res. 2016 Dec;30(12):3329-3338. doi: 10.1519/JSC.0000000000001439.
- Faul F, Erdfelder E, Lang AG, Buchner A. G*Power 3: a flexible statistical power analysis program for the social, behavioral, and biomedical sciences. Behav Res Methods. 2007 May;39(2):175-91. doi: 10.3758/bf03193146.
- Hamblin MR. Shining light on the head: Photobiomodulation for brain disorders. BBA Clin. 2016 Oct 1;6:113-124. doi: 10.1016/j.bbacli.2016.09.002. eCollection 2016 Dec.
- de Oliveira AR, Vanin AA, Tomazoni SS, Miranda EF, Albuquerque-Pontes GM, De Marchi T, Dos Santos Grandinetti V, de Paiva PRV, Imperatori TBG, de Carvalho PTC, Bjordal JM, Leal-Junior ECP. Pre-Exercise Infrared Photobiomodulation Therapy (810 nm) in Skeletal Muscle Performance and Postexercise Recovery in Humans: What Is the Optimal Power Output? Photomed Laser Surg. 2017 Nov;35(11):595-603. doi: 10.1089/pho.2017.4343.
- Antonialli FC, De Marchi T, Tomazoni SS, Vanin AA, dos Santos Grandinetti V, de Paiva PR, Pinto HD, Miranda EF, de Tarso Camillo de Carvalho P, Leal-Junior EC. Phototherapy in skeletal muscle performance and recovery after exercise: effect of combination of super-pulsed laser and light-emitting diodes. Lasers Med Sci. 2014 Nov;29(6):1967-76. doi: 10.1007/s10103-014-1611-7. Epub 2014 Jun 19.
- Leal Junior EC, Lopes-Martins RA, Baroni BM, De Marchi T, Rossi RP, Grosselli D, Generosi RA, de Godoi V, Basso M, Mancalossi JL, Bjordal JM. Comparison between single-diode low-level laser therapy (LLLT) and LED multi-diode (cluster) therapy (LEDT) applications before high-intensity exercise. Photomed Laser Surg. 2009 Aug;27(4):617-23. doi: 10.1089/pho.2008.2350.
- Vieira WH, Ferraresi C, Perez SE, Baldissera V, Parizotto NA. Effects of low-level laser therapy (808 nm) on isokinetic muscle performance of young women submitted to endurance training: a randomized controlled clinical trial. Lasers Med Sci. 2012 Mar;27(2):497-504. doi: 10.1007/s10103-011-0984-0. Epub 2011 Aug 26.
- Baroni BM, Leal Junior EC, De Marchi T, Lopes AL, Salvador M, Vaz MA. Low level laser therapy before eccentric exercise reduces muscle damage markers in humans. Eur J Appl Physiol. 2010 Nov;110(4):789-96. doi: 10.1007/s00421-010-1562-z. Epub 2010 Jul 3.
- Dornelles MP, Fritsch CG, Sonda FC, Johnson DS, Leal-Junior ECP, Vaz MA, Baroni BM. Photobiomodulation therapy as a tool to prevent hamstring strain injuries by reducing soccer-induced fatigue on hamstring muscles. Lasers Med Sci. 2019 Aug;34(6):1177-1184. doi: 10.1007/s10103-018-02709-w. Epub 2019 Jan 3.
- Dompe C, Moncrieff L, Matys J, Grzech-Lesniak K, Kocherova I, Bryja A, Bruska M, Dominiak M, Mozdziak P, Skiba THI, Shibli JA, Angelova Volponi A, Kempisty B, Dyszkiewicz-Konwinska M. Photobiomodulation-Underlying Mechanism and Clinical Applications. J Clin Med. 2020 Jun 3;9(6):1724. doi: 10.3390/jcm9061724.
- Tomazoni SS, Machado CDSM, De Marchi T, Casalechi HL, Bjordal JM, de Carvalho PTC, Leal-Junior ECP. Infrared Low-Level Laser Therapy (Photobiomodulation Therapy) before Intense Progressive Running Test of High-Level Soccer Players: Effects on Functional, Muscle Damage, Inflammatory, and Oxidative Stress Markers-A Randomized Controlled Trial. Oxid Med Cell Longev. 2019 Nov 16;2019:6239058. doi: 10.1155/2019/6239058. eCollection 2019.
- Ailioaie LM, Litscher G. Photobiomodulation and Sports: Results of a Narrative Review. Life (Basel). 2021 Dec 3;11(12):1339. doi: 10.3390/life11121339.
- Aver Vanin A, De Marchi T, Tomazoni SS, Tairova O, Leao Casalechi H, de Tarso Camillo de Carvalho P, Bjordal JM, Leal-Junior EC. Pre-Exercise Infrared Low-Level Laser Therapy (810 nm) in Skeletal Muscle Performance and Postexercise Recovery in Humans, What Is the Optimal Dose? A Randomized, Double-Blind, Placebo-Controlled Clinical Trial. Photomed Laser Surg. 2016 Oct;34(10):473-482. doi: 10.1089/pho.2015.3992. Epub 2016 Aug 29.
- Baroni BM, Rodrigues R, Freire BB, Franke Rde A, Geremia JM, Vaz MA. Effect of low-level laser therapy on muscle adaptation to knee extensor eccentric training. Eur J Appl Physiol. 2015 Mar;115(3):639-47. doi: 10.1007/s00421-014-3055-y. Epub 2014 Nov 23.
- de Carvalho G, Gobbi A, Gobbi RB, Alfredo DMN, do Carmo Furquim TH, Barbosa RI, Papoti M, de Jesus Guirro RR. Photobiomodulation by light emitting diode applied sequentially does not alter performance in cycling athletes. Lasers Med Sci. 2020 Oct;35(8):1769-1779. doi: 10.1007/s10103-020-02973-9. Epub 2020 Feb 20.
- De Marchi T, Leal-Junior ECP, Lando KC, Cimadon F, Vanin AA, da Rosa DP, Salvador M. Photobiomodulation therapy before futsal matches improves the staying time of athletes in the court and accelerates post-exercise recovery. Lasers Med Sci. 2019 Feb;34(1):139-148. doi: 10.1007/s10103-018-2643-1. Epub 2018 Sep 27.
- de Paiva PR, Tomazoni SS, Johnson DS, Vanin AA, Albuquerque-Pontes GM, Machado CD, Casalechi HL, de Carvalho PT, Leal-Junior EC. Photobiomodulation therapy (PBMT) and/or cryotherapy in skeletal muscle restitution, what is better? A randomized, double-blinded, placebo-controlled clinical trial. Lasers Med Sci. 2016 Dec;31(9):1925-1933. doi: 10.1007/s10103-016-2071-z. Epub 2016 Sep 13.
- Ferraresi C, Bertucci D, Schiavinato J, Reiff R, Araujo A, Panepucci R, Matheucci E Jr, Cunha AF, Arakelian VM, Hamblin MR, Parizotto N, Bagnato V. Effects of Light-Emitting Diode Therapy on Muscle Hypertrophy, Gene Expression, Performance, Damage, and Delayed-Onset Muscle Soreness: Case-control Study with a Pair of Identical Twins. Am J Phys Med Rehabil. 2016 Oct;95(10):746-57. doi: 10.1097/PHM.0000000000000490.
- Leal Junior EC, de Godoi V, Mancalossi JL, Rossi RP, De Marchi T, Parente M, Grosselli D, Generosi RA, Basso M, Frigo L, Tomazoni SS, Bjordal JM, Lopes-Martins RA. Comparison between cold water immersion therapy (CWIT) and light emitting diode therapy (LEDT) in short-term skeletal muscle recovery after high-intensity exercise in athletes--preliminary results. Lasers Med Sci. 2011 Jul;26(4):493-501. doi: 10.1007/s10103-010-0866-x. Epub 2010 Nov 19.
- Rossato M, Dellagrana RA, Sakugawa RL, Baroni BM, Diefenthaeler F. Dose-Response Effect of Photobiomodulation Therapy on Muscle Performance and Fatigue During a Multiple-Set Knee Extension Exercise: A Randomized, Crossover, Double-Blind Placebo-Controlled Trial. Photobiomodul Photomed Laser Surg. 2020 Dec;38(12):758-765. doi: 10.1089/photob.2020.4820. Epub 2020 Nov 24.
- Wyatt Daniel Army Staff SGT. Program boosts special forces members' physical, mental capabilities. U.S. Department of Defense. December 6, 2017. Accessed July 13, 2022. https://www.defense.gov/News/News-Stories/Article/Article/1389545/program-boosts-specialforces- members-physical-mental-capabilities/
- Vanin AA, Miranda EF, Machado CS, de Paiva PR, Albuquerque-Pontes GM, Casalechi HL, de Tarso Camillo de Carvalho P, Leal-Junior EC. What is the best moment to apply phototherapy when associated to a strength training program? A randomized, double-blinded, placebo-controlled trial : Phototherapy in association to strength training. Lasers Med Sci. 2016 Nov;31(8):1555-1564. doi: 10.1007/s10103-016-2015-7. Epub 2016 Jul 1.
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
23 de enero de 2025
Finalización primaria (Actual)
2 de marzo de 2026
Finalización del estudio (Actual)
2 de marzo de 2026
Fechas de registro del estudio
Enviado por primera vez
13 de marzo de 2024
Primero enviado que cumplió con los criterios de control de calidad
18 de abril de 2024
Publicado por primera vez (Actual)
23 de abril de 2024
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
15 de junio de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
18 de mayo de 2026
Última verificación
1 de mayo de 2026
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- USUHS.2023-126
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
SÍ
Descripción del plan IPD
El Formulario de consentimiento inicial (ICF) para este estudio de investigación establece que los datos de investigación no identificados se compartirán con MIRROR y USU y se mantendrán indefinidamente para su posible uso en investigaciones futuras. Al dar su consentimiento para participar en este estudio de investigación, los participantes aceptan permitirnos mantener sus datos de investigación anónimos indefinidamente para su posible uso en investigaciones futuras.
Los participantes no tendrán la opción de optar por que no conservemos sus datos de investigación anónimos indefinidamente para un posible uso futuro. La ICF establece: "Si no desea que sus datos no identificados recopilados como parte de este estudio de investigación se conserven para su uso en futuros estudios de investigación, no debe firmar este formulario de consentimiento".
Tipo de información de apoyo para compartir IPD
- PROTOCOLO DE ESTUDIO
- SAVIA
- CIF
- CÓDIGO_ANALÍTICO
- RSC
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
Sí
producto fabricado y exportado desde los EE. UU.
Sí
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .