Проект фотомедицины 14: PBMT для повышения производительности сил специального назначения (SOF)
18 мая 2026 г. обновлено: Musculoskeletal Injury Rehabilitation Research for Operational Readiness
Оценка влияния применения фотобиомодуляции после упражнений на работоспособность, восстановление и поведенческое состояние у обученных специальных операторов
Силы специальных операций (ССО) постоянно тренируются, чтобы поддерживать максимальную производительность. Таким образом, они почти всегда находятся в состоянии выздоровления и нуждаются в неинвазивных методах лечения, чтобы справиться с тяжелой рабочей нагрузкой. Фотобиомодуляционная терапия (ПБМТ) — это неинвазивный метод лечения, при котором к телу применяется лазер низкой мощности для улучшения заживления, восстановления и работоспособности. Армейская тактическая оптимизация человеческого потенциала, быстрая реабилитация и восстановление (THOR3) обеспечивает последовательные возможности для внедрения PBMT в качестве метода. Исследования на спортсменах показали улучшение производительности и восстановления при фокальном применении PBMT до и после тренировки. Несмотря на то, что имеется меньше доказательств потенциальных когнитивных/поведенческих эффектов систематического применения PBMT, было также обнаружено, что утомляемость, о которой сообщают сами люди, значительно ниже в группах с локальным применением PBMT по сравнению с плацебо. Кроме того, исследования PBMT у здоровых военных спортсменов-тактиков ограничены. PBMT может быть многообещающим инструментом для повышения физической работоспособности за счет ускорения скелетно-мышечного и психологического восстановления среди населения ССО. Целью исследователей является изучение физиологического и поведенческого воздействия применения PBMT после тренировки на работоспособность операторов ССО.
Цель: Исследователи предлагают провести одинарное слепое рандомизированное контрольное исследование с имитацией контроля для изучения эффективности проведения PBMT после физической подготовки в популяции ССО.
Конкретные цели данного исследования заключаются в следующем:
- Проанализируйте и опишите физиологические эффекты, если таковые имеются, применения PBMT после тренировок у операторов спецназа, проходящих обучение под руководством тренера.
- Проанализируйте и опишите поведенческие эффекты, если таковые имеются, применения PBMT после упражнений у операторов спецназа, проходящих обучение под руководством тренера.
- Оценить общую клиническую полезность фокальной ПБМТ после физической подготовки среди тактических спортсменов ССО армии США.
Обзор исследования
Статус
Завершенный
Условия
Тип исследования
Интервенционный
Регистрация (Действительный)
29
Фаза
- Непригодный
Контакты и местонахождение
В этом разделе приведены контактные данные лиц, проводящих исследование, и информация о том, где проводится это исследование.
Места учебы
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Washington
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Joint Base Lewis McChord, Washington, Соединенные Штаты, 98433
- Joint Base Lewis-McChord
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Критерии участия
Исследователи ищут людей, которые соответствуют определенному описанию, называемому критериям приемлемости. Некоторыми примерами этих критериев являются общее состояние здоровья человека или предшествующее лечение.
Критерии приемлемости
Возраст, подходящий для обучения
- Взрослый
Принимает здоровых добровольцев
Да
Описание
Критерии включения:
- Действующий персонал спецназа (18-я серия)
- Способен читать и понимать английский язык для целей согласия
- Способность взять на себя обязательство изучить вмешательство и последующее наблюдение
- Возможность участвовать в тренинге для тренеров THOR3 без ограничений.
Критерий исключения:
- Ожирение (жировые отложения > 25%)
- Сердечно-сосудистые заболевания
- Использование некоторых лекарств (например, статинов, диуретиков, гипертензивных средств)
- Женский
- Татуировка в зоне лечения (область тела)
- Диагноз порфирия (световая аллергия) или фоточувствительная экзема.
- Текущее использование лекарств, связанных с чувствительностью к теплу или свету (например, амиодарон, хлорпромазин, доксициклин, гидрохлоротиазид, налидиксовая кислота, напроксен, пироксикам, тетрациклин, тиоридазин, вориконазол)
- Использование кардиостимулятора/основное заболевание сердца
- Диагностировано аутоиммунное заболевание(я)
- Альбинизм
- Периферическая нейропатия
Учебный план
В этом разделе представлена подробная информация о плане исследования, в том числе о том, как планируется исследование и что оно измеряет.
Как устроено исследование?
Детали дизайна
- Основная цель: Уход
- Распределение: Рандомизированный
- Интервенционная модель: Параллельное назначение
- Маскировка: Одинокий
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
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Фальшивый компаратор: Шам ПБМТ
Включение фиктивного PBMT обеспечит сохранение всех процедур лечения участников, за исключением испускания фотонов (активное лечение), что позволит отнести любые различия между группами на счет использования PBMT.
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Имитация PBMT будет предоставлена обученным членом исследовательской группы.
Имитация PBMT будет доставлена таким же образом, как указано выше для процесса PBMT, но устройство останется в режиме ожидания (т. е. режим лечения не будет включен).
Поскольку инфракрасный свет невидим невооруженным глазом, единственной видимой разницей между режимами лечения и режимом ожидания является наличие нескольких крошечных янтарных лампочек (эти индикаторы горят во время режима лечения).
Другие имена:
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Активный компаратор: Photobiomodulation Treatment (PBMT)
PBMT will be delivered at 40 watts (W).
PBMT will be applied to the quadriceps area.
A study team member will use the quadriceps measurements of the treatment area to calculate the PBMT treatment time (approximately 5-20 minutes) and specified J/cm2.
PBMT treatment will be provided 3 times per week, for 3 weeks.
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PBMT will be delivered at 40W (depending on participant skin pigmentation). PBMT will be applied to the quadriceps area. A study team member will use the quadriceps measurements of the treatment area to calculate the PBMT treatment time (approximately 5-20 minutes) and specified J/cm2. PBMT treatment will be provided 3 times per week, for 3 weeks. PBMT will be delivered by a trained study team member using the LightForce® XLi 40W device with the Smart Hand Piece technology, which has a built-in accelerometer in the hand piece that controls the speed of light delivery to the treatment area. The trained team members will use the Smart Hand Piece technology, which assesses the operator's speed and provides real-time visual and sensory feedback calibrated to shut-off when moving too slowly and warns the operator when moving too quickly by vibrating. Treatment is delivered through a flexible optical fiber threaded through the hand piece, which contains a rolling glass massage ball.
Другие имена:
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Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
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Countermovement Jump (CMJ) Initial Baseline: Concentric Impulse
Временное ограничение: Collected prior to treatment starting at time of enrollment.
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Assesses dynamic strength performance, including concentric impulse via force plates and analysis software.
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Collected prior to treatment starting at time of enrollment.
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Countermovement Jump (CMJ) Initial Baseline: Movement Start to Peak Power.
Временное ограничение: Collected prior to treatment starting at time of enrollment.
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Assesses dynamic strength performance, including Movement start to peak power.
via force plates and analysis software.
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Collected prior to treatment starting at time of enrollment.
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Countermovement Jump (CMJ) Initial Baseline: Reactive Strength Index-modified (RSImod)
Временное ограничение: Collected prior to treatment starting at time of enrollment.
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Assesses dynamic strength performance, including Reactive Strength Index-modified (RSImod) via force plates and analysis software. Reactive Strength Index-modified (RSImod) reflects the efficiency of force production during a countermovement jump. It is calculated as jump height divided by time to take-off. Higher values indicate better explosive performance and lower neuromuscular fatigue, whereas lower values indicate reduced efficiency or increased fatigue. The index ranges from 0 upward with no theoretical maximum; therefore, interpretation should rely on normative ranges or athlete-specific baselines. Reference categories: Lower performers (L): ~0.20-0.30 Moderate performers (M): ~0.30-0.45 Upper performers (U): ~0.45-0.70+ |
Collected prior to treatment starting at time of enrollment.
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Countermovement Jump (CMJ) Initial Baseline: Time to Take-Off
Временное ограничение: Collected prior to treatment starting at time of enrollment.
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Assesses dynamic strength performance, including Time to Take-Off via force plates and analysis software.
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Collected prior to treatment starting at time of enrollment.
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Countermovement Jump (CMJ) Week 1 Follow-up: Concentric Impulse
Временное ограничение: Collected at the end of week 1 prior to coach-led training.
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Assesses dynamic strength performance, including concentric impulse via force plates and analysis software.
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Collected at the end of week 1 prior to coach-led training.
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Countermovement Jump (CMJ) Week 1 Follow-up: Movement Start to Peak Power
Временное ограничение: Collected at the end of week 1 prior to coach-led training.
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Assesses dynamic strength performance, including Movement Start to peak Power via force plates and analysis software.
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Collected at the end of week 1 prior to coach-led training.
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Countermovement Jump (CMJ) Week 1 Follow-up: Reactive Strength Index-modified (RSImod)
Временное ограничение: Collected at the end of week 1 prior to coach-led training.
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Assesses dynamic strength performance, including Reactive Strength Index-modified (RSImod) via force plates and analysis software. Reactive Strength Index-modified (RSImod) reflects the efficiency of force production during a countermovement jump. It is calculated as jump height divided by time to take-off. Higher values indicate better explosive performance and lower neuromuscular fatigue, whereas lower values indicate reduced efficiency or increased fatigue. The index ranges from 0 upward with no theoretical maximum; therefore, interpretation should rely on normative ranges or athlete-specific baselines. Reference categories: Lower performers (L): ~0.20-0.30 Moderate performers (M): ~0.30-0.45 Upper performers (U): ~0.45-0.70+ |
Collected at the end of week 1 prior to coach-led training.
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Countermovement Jump (CMJ) Week 1 Follow-up: Time to Take-Off
Временное ограничение: Collected at the end of week 1 prior to coach-led training.
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Assesses dynamic strength performance, including Time to Take-Off via force plates and analysis software.
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Collected at the end of week 1 prior to coach-led training.
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Countermovement Jump (CMJ) Week 2 Follow-up: Concentric Impulse
Временное ограничение: Collected at the end of week 2 prior to coach-led training.
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Assesses dynamic strength performance, including concentric impulse via force plates and analysis software.
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Collected at the end of week 2 prior to coach-led training.
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Countermovement Jump (CMJ) Week 2 Follow-up: Movement Start to Peak Power
Временное ограничение: Collected at the end of week 2 prior to coach-led training.
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Assesses dynamic strength performance, including peak force production via force plates and analysis software.
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Collected at the end of week 2 prior to coach-led training.
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Countermovement Jump (CMJ) Week 2 Follow-up: Reactive Strength Index-modified (RSImod)
Временное ограничение: Collected at the end of week 2 prior to coach-led training.
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Assesses dynamic strength performance, including Reactive Strength Index-modified (RSImod) via force plates and analysis software. Reactive Strength Index-modified (RSImod) reflects the efficiency of force production during a countermovement jump. It is calculated as jump height divided by time to take-off. Higher values indicate better explosive performance and lower neuromuscular fatigue, whereas lower values indicate reduced efficiency or increased fatigue. The index ranges from 0 upward with no theoretical maximum; therefore, interpretation should rely on normative ranges or athlete-specific baselines. Reference categories: Lower performers (L): ~0.20-0.30 Moderate performers (M): ~0.30-0.45 Upper performers (U): ~0.45-0.70+ |
Collected at the end of week 2 prior to coach-led training.
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Countermovement Jump (CMJ) Week 2 Follow-up: Time to Take-Off
Временное ограничение: Collected at the end of week 2 prior to coach-led training.
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Assesses dynamic strength performance, including Time to Take-Off via force plates and analysis software.
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Collected at the end of week 2 prior to coach-led training.
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Countermovement Jump (CMJ) Week 3 Follow-up: Concentric Impulse
Временное ограничение: Collected at the end of week 3 prior to coach-led training.
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Assesses dynamic strength performance, including concentric impulse via force plates and analysis software.
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Collected at the end of week 3 prior to coach-led training.
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Countermovement Jump (CMJ) Week 3 Follow-up: Movement Start to Peak Power
Временное ограничение: Collected at the end of week 3 prior to coach-led training.
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Assesses dynamic strength performance, including peak force production via force plates and analysis software.
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Collected at the end of week 3 prior to coach-led training.
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Countermovement Jump (CMJ) Week 3 Follow-up: Reactive Strength Index-modified (RSImod)
Временное ограничение: Collected at the end of week 3 prior to coach-led training.
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Assesses dynamic strength performance, including Reactive Strength Index-modified (RSImod) via force plates and analysis software. Reactive Strength Index-modified (RSImod) reflects the efficiency of force production during a countermovement jump. It is calculated as jump height divided by time to take-off. Higher values indicate better explosive performance and lower neuromuscular fatigue, whereas lower values indicate reduced efficiency or increased fatigue. The index ranges from 0 upward with no theoretical maximum; therefore, interpretation should rely on normative ranges or athlete-specific baselines. Reference categories: Lower performers (L): ~0.20-0.30 Moderate performers (M): ~0.30-0.45 Upper performers (U): ~0.45-0.70+ |
Collected at the end of week 3 prior to coach-led training.
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Countermovement Jump (CMJ) Week 3 Follow-up: Time to Take-Off
Временное ограничение: Collected at the end of week 3 prior to coach-led training.
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Assesses dynamic strength performance, including Time to Take-Off via force plates and analysis software.
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Collected at the end of week 3 prior to coach-led training.
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Isometric Quadriceps Strength Testing Initial Baseline: Peak Torque
Временное ограничение: Collected prior to treatment starting at time of enrollment.
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Measuring isolated strength (Peak Torque).
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Collected prior to treatment starting at time of enrollment.
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Isometric Hamstrings Strength Testing Initial Baseline: Peak Torque.
Временное ограничение: Collected prior to treatment starting at time of enrollment.
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Measuring isolated strength (Peak Torque).
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Collected prior to treatment starting at time of enrollment.
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Isokinetic Quadriceps Strength Testing Initial Baseline: Peak Torque
Временное ограничение: Collected prior to treatment starting at time of enrollment.
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Measuring isolated strength (Peak Torque).
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Collected prior to treatment starting at time of enrollment.
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Isokinetic Hamstrings Strength Testing Initial Baseline: Peak Torque
Временное ограничение: Collected prior to treatment starting at time of enrollment.
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Measuring isolated strength (Peak Torque).
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Collected prior to treatment starting at time of enrollment.
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Isometric Quadriceps Strength Testing 3-week Follow-up: Peak Torque
Временное ограничение: Collected at the 3-week follow-up session prior to coach-led training.
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Measuring isolated strength (Peak Torque).
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Collected at the 3-week follow-up session prior to coach-led training.
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Isometric Hamstrings Strength Testing 3-week Follow-up: Peak Torque.
Временное ограничение: Collected at the 3-week follow-up session prior to coach-led training.
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Measuring isolated strength (Peak Torque).
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Collected at the 3-week follow-up session prior to coach-led training.
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Isokinetic Quadriceps Strength Testing 3-week Follow-up: Peak Torque
Временное ограничение: Collected at the 3-week follow-up session prior to coach-led training.
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Measuring isolated strength (Peak Torque).
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Collected at the 3-week follow-up session prior to coach-led training.
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Isokinetic Hamstrings Strength Testing 3-week Follow-up: Peak Torque
Временное ограничение: Collected at the 3-week follow-up session prior to coach-led training.
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Measuring isolated strength (Peak Torque).
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Collected at the 3-week follow-up session prior to coach-led training.
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Defense and Veteran's Pain Rating Scale (DVPRS) Initial Baseline
Временное ограничение: Self-reported at baseline
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Captures subjective pain rating on a 0 - 10 scale (minimum - maximum; 0 = no pain, 10 = severe pain).
Higher scores equal worse outcomes.
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Self-reported at baseline
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Defense and Veteran's Pain Rating Scale (DVPRS) Daily Reports
Временное ограничение: Self-reported, daily after baseline through study completion after 3 weeks.
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Captures subjective pain rating on a 0 - 10 scale (minimum - maximum; 0 = no pain, 10 = severe pain).
Higher scores equals worse outcomes.
Calculation for this timepoint was dervied from averaging all daily pain scores into an aggregate value.
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Self-reported, daily after baseline through study completion after 3 weeks.
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Visual Analog Scale (VAS) Initial Baseline
Временное ограничение: Collected prior to treatment starting at time of enrollment.
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Measures delayed onset muscle soreness.
Respondents mark on a 10 centimeter line their current level of muscle soreness.
The left end of the line represents "I feel no soreness in my muscles" and the right end represents "My muscles feel so sore, I don't want to move them."
Scores range from 0-100, with higher scores equaling worse outcomes.
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Collected prior to treatment starting at time of enrollment.
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Visual Analog Scale (VAS) Week 1 Follow-up
Временное ограничение: Collected at the end of week 1 after coach-led training and laser treatment.
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Measures delayed onset muscle soreness.
Respondents mark on a 10 centimeter line their current level of muscle soreness.
The left end of the line represents "I feel no soreness in my muscles" and the right end represents "My muscles feel so sore, I don't want to move them."
Scores range from 0-100, with higher scores equaling worse outcomes.
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Collected at the end of week 1 after coach-led training and laser treatment.
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Visual Analog Scale (VAS) Week 2 Follow-up
Временное ограничение: Collected at the end of week 2 after coach-led training and laser treatment.
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Measures delayed onset muscle soreness.
Respondents mark on a 10 centimeter line their current level of muscle soreness.
The left end of the line represents "I feel no soreness in my muscles" and the right end represents "My muscles feel so sore, I don't want to move them."
Scores range from 0-100, with higher scores equaling worse outcomes.
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Collected at the end of week 2 after coach-led training and laser treatment.
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Visual Analog Scale (VAS) Week 3 Follow-up
Временное ограничение: Collected at the end of week 3 after coach-led training and laser treatment.
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Measures delayed onset muscle soreness.
Respondents mark on a 10 centimeter line their current level of muscle soreness.
The left end of the line represents "I feel no soreness in my muscles" and the right end represents "My muscles feel so sore, I don't want to move them."
Scores range from 0-100, with higher scores equaling worse outcomes.
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Collected at the end of week 3 after coach-led training and laser treatment.
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Borg Modified Rating of Perceived Exertion (RPE) Initial Baseline
Временное ограничение: Collected prior to treatment starting at time of enrollment
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Quantifying perceived exertion on 0-10 scale.
Higher scores indicate worse outcomes.
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Collected prior to treatment starting at time of enrollment
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Borg Modified Rating of Perceived Exertion (RPE) 3-week Follow-up
Временное ограничение: Collected at the 3-week follow-up session after coach-led training and laser treatment.
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Quantifying perceived exertion on 0-10 scale.
Higher scores indicate worse outcomes.
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Collected at the 3-week follow-up session after coach-led training and laser treatment.
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Elloumi Fatigue Scale Initial Baseline
Временное ограничение: Collected prior to treatment starting at time of enrollment.
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Behavioral health rating of fatigue.
The short questionnaire of fatigue uses eight questions that highlight perception of training difficulty, sleep, leg discomfort, infection/colds, concentration, work efficacy, anxiety and overall stress.
Each question is rated by the respondent on a 7-point scale: 1 point (not at all) to 7 points (very much).
The summed total score of the 8 questions allows for a total score of fatigue (TSF).
Total score of fatigue ranges from 8 points (not at all fatigued) to 56 points (very much fatigued).
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Collected prior to treatment starting at time of enrollment.
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Elloumi Fatigue Scale 3-week Follow-up
Временное ограничение: Collected at the 3-week follow-up session after coach-led training and laser treatment.
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Behavioral health rating of fatigue.
The short questionnaire of fatigue uses eight questions that highlight perception of training difficulty, sleep, leg discomfort, infection/colds, concentration, work efficacy, anxiety and overall stress.
Each question is rated by the respondent on a 7-point scale: 1 point (not at all) to 7 points (very much).
The summed total score of the 8 questions allows for a total score of fatigue (TSF).
Total score of fatigue ranges from 8 points (not at all fatigued) to 56 points (very much fatigued).
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Collected at the 3-week follow-up session after coach-led training and laser treatment.
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Quick Physical Activity Rating Scale (QPAR)
Временное ограничение: Collected prior to treatment starting at time of enrollment.
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Higher scores indicate better outcome.
Scaled rating of various types of physical activity participation.
Respondent reporting quantifies the overall amount of physical activity that the respondent regularly engages in.
Activities are weighted in intensity that ranges from 1 (light) to 3 (heavy).
Activity weekly frequency reported as never (0 days), seldom (1-2 days), sometime (3-4 days), and often (5-7 days).
Activity duration collected as less than one hour per day, 1-2 hours per day, and more than two hours per day.
Intensity (1-3), frequency (0-3) and duration (1-3) scores are multiplied and provide a physical activity score that may range from 0 - 153 points, 0 being very low physical activity and 153 representing very high physical activity.
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Collected prior to treatment starting at time of enrollment.
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Oura Ring Sleep Data: Sleep Metrics - Sleep Duration
Временное ограничение: Oura data is collected from daily wear of ring from date of randomization through study completion after 3 weeks.
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Oura Ring will continuously measure aspects of sleep, including duration of sleep.
Calculation for this measure was dervied from averaging all daily sleep scores into an aggregate value.
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Oura data is collected from daily wear of ring from date of randomization through study completion after 3 weeks.
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Oura Ring Sleep Data: Sleep Metrics - Time in Bed
Временное ограничение: Oura data is collected from daily wear of ring from date of randomization through study completion after 3 weeks.
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Oura Ring will continuously measure aspects of sleep, including time spent in bed.
Calculation for this measure was dervied from averaging all daily scores into an aggregate value.
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Oura data is collected from daily wear of ring from date of randomization through study completion after 3 weeks.
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Oura Ring Sleep Data: Sleep Metrics - Light Sleep Length
Временное ограничение: Oura data is collected from daily wear of ring from date of randomization through study completion after 3 weeks.
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Oura Ring will continuously measure aspects of sleep, including duration of light sleep stage.
Calculation for this measure was dervied from averaging all daily scores into an aggregate value.
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Oura data is collected from daily wear of ring from date of randomization through study completion after 3 weeks.
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Oura Ring Sleep Data: Sleep Metrics - Rapid Eye Movement (REM) Sleep Length
Временное ограничение: Oura data is collected from daily wear of ring from date of randomization through study completion after 3 weeks.
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Oura Ring will continuously measure aspects of sleep, including duration of REM sleep stage.
Calculation for this measure was dervied from averaging all daily scores into an aggregate value.
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Oura data is collected from daily wear of ring from date of randomization through study completion after 3 weeks.
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Oura Ring Sleep Data: Sleep Metrics - Deep Sleep Length
Временное ограничение: Oura data is collected from daily wear of ring from date of randomization through study completion after 3 weeks.
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Oura Ring will continuously measure aspects of sleep, including duration of deep sleep stage (seconds).
Calculation for this measure was dervied from averaging all daily scores into an aggregate value.
|
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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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)
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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.
|
Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Body Measurements: Body Composition (% Body Fat)
Временное ограничение: Measured prior to treatment starting at time of enrollment.
|
Biometrics
|
Measured prior to treatment starting at time of enrollment.
|
|
Body Measurements: Height (Inches)
Временное ограничение: Measured prior to treatment starting at time of enrollment.
|
Biometrics
|
Measured prior to treatment starting at time of enrollment.
|
|
Body Measurements: Weight (Lbs)
Временное ограничение: 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)
Временное ограничение: 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)
Временное ограничение: 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)
Временное ограничение: Measured prior to treatment starting at time of enrollment.
|
Biometrics - used to calculate PBMT dosage
|
Measured prior to treatment starting at time of enrollment.
|
Другие показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Размеры тела: Рост (см)
Временное ограничение: Измерялось до начала лечения в момент включения в программу.
|
Биометрия
|
Измерялось до начала лечения в момент включения в программу.
|
|
Размеры тела: Вес (кг/фунты)
Временное ограничение: Измерялось до начала лечения в момент включения в программу.
|
Биометрия
|
Измерялось до начала лечения в момент включения в программу.
|
|
Параметры тела: Состав тела (% жира в организме)
Временное ограничение: Измерялось до начала лечения в момент включения в программу.
|
Биометрия
|
Измерялось до начала лечения в момент включения в программу.
|
|
Обмеры тела: C1 – окружность бедра проксимальной части (см).
Временное ограничение: Измерялось до начала лечения в момент включения в программу.
|
Биометрия - используется для расчета дозировки ПБМТ.
|
Измерялось до начала лечения в момент включения в программу.
|
|
Обмеры тела: C2 – окружность бедра по дистальной части (см).
Временное ограничение: Измерялось до начала лечения в момент включения в программу.
|
Биометрия - используется для расчета дозировки ПБМТ.
|
Измерялось до начала лечения в момент включения в программу.
|
|
Обмеры тела: L1 – длина бедра (см).
Временное ограничение: Измерялось до начала лечения в момент включения в программу.
|
Биометрия - используется для расчета дозировки ПБМТ.
|
Измерялось до начала лечения в момент включения в программу.
|
Соавторы и исследователи
Здесь вы найдете людей и организации, участвующие в этом исследовании.
Соавторы
Следователи
- Главный следователь: Tanner Santarelli, DPT, 1st Special Forces Group Tactical Human Optimization, Rapid Rehabilitation and Reconditioning (THOR3)
Публикации и полезные ссылки
Лицо, ответственное за внесение сведений об исследовании, добровольно предоставляет эти публикации. Это может быть что угодно, связанное с исследованием.
Общие публикации
- 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.
Даты записи исследования
Эти даты отслеживают ход отправки отчетов об исследованиях и сводных результатов на сайт ClinicalTrials.gov. Записи исследований и сообщаемые результаты проверяются Национальной медицинской библиотекой (NLM), чтобы убедиться, что они соответствуют определенным стандартам контроля качества, прежде чем публиковать их на общедоступном веб-сайте.
Изучение основных дат
Начало исследования (Действительный)
23 января 2025 г.
Первичное завершение (Действительный)
2 марта 2026 г.
Завершение исследования (Действительный)
2 марта 2026 г.
Даты регистрации исследования
Первый отправленный
13 марта 2024 г.
Впервые представлено, что соответствует критериям контроля качества
18 апреля 2024 г.
Первый опубликованный (Действительный)
23 апреля 2024 г.
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
15 июня 2026 г.
Последнее отправленное обновление, отвечающее критериям контроля качества
18 мая 2026 г.
Последняя проверка
1 мая 2026 г.
Дополнительная информация
Термины, связанные с этим исследованием
Дополнительные соответствующие термины MeSH
Другие идентификационные номера исследования
- USUHS.2023-126
Планирование данных отдельных участников (IPD)
Планируете делиться данными об отдельных участниках (IPD)?
ДА
Описание плана IPD
В форме первоначального согласия (ICF) на это исследование указано, что обезличенные данные исследования будут переданы MIRROR и УрГУ и храниться в течение неопределенного времени для возможного использования в будущих исследованиях. Соглашаясь на участие в этом исследовании, участники соглашаются разрешить нам хранить их обезличенные исследовательские данные на неопределенный срок для возможного использования в будущих исследованиях.
Участникам не будет предоставлена возможность отказаться от нашего сохранения обезличенных исследовательских данных на неопределенный срок для возможного использования в будущем. ICF заявляет: «Если вы не хотите, чтобы ваши обезличенные данные, собранные в рамках этого исследования, сохранялись для использования в будущих исследованиях, вам не следует подписывать эту форму согласия».
Совместное использование IPD Поддерживающий тип информации
- STUDY_PROTOCOL
- САП
- МКФ
- АНАЛИТИЧЕСКИЙ_КОД
- КСО
Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Нет
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
Да
продукт, произведенный в США и экспортированный из США.
Да
Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .