光医学项目 14：用于 SOF 性能增强的 PBMT (SOF)
评估运动后光生物调节应用对受过训练的特种操作员群体的表现、恢复和行为状态的影响
特种作战部队 (SOF) 不断训练以保持最佳表现。 因此，他们几乎总是处于康复状态，需要非侵入性治疗来解决繁重的工作量。 光生物调节疗法 (PBMT) 是一种无创治疗方法，将低强度激光应用于身体以增强愈合、恢复和性能。 陆军战术人体优化快速康复和修复 (THOR3) 为实施 PBMT 作为一种模式提供了一致的途径。 对运动员的研究表明，锻炼前和锻炼后重点应用 PBMT 对运动表现和恢复都有好处。 虽然关于系统应用 PBMT 对认知/行为的潜在影响的证据较少，但与安慰剂相比，局部 PBMT 应用组的自我报告疲劳程度也显着降低。 此外，针对健康军事战术运动员的 PBMT 研究也很有限。 PBMT 可能是一种很有前途的工具，可以通过加速 SOF 人群的肌肉骨骼和心理恢复来增强身体表现。 研究人员旨在研究 PBMT 训练后应用对 SOF 操作员表现的生理和行为影响。
目的：研究人员建议进行一项带有假对照的单盲随机对照试验，以调查在 SOF 人群中提供 PBMT 体能训练后的有效性。
本研究的具体目的是：
- 分析并描述接受教练指导训练的特种部队操作员训练后应用 PBMT 的生理效应（如果有）。
- 分析并描述接受教练指导训练的特种部队操作员演习后应用 PBMT 的行为影响（如果有）。
- 评估美国陆军特种部队、战术运动员群体体能训练后局部 PBMT 的整体临床效用。
研究概览
地位
完全的
研究类型
介入性
注册 (实际的)
29
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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Washington
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Joint Base Lewis McChord、Washington、美国、98433
- Joint Base Lewis-McChord
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 成人
接受健康志愿者
是的
描述
纳入标准：
- 现役特种部队人员（18系列）
- 能够出于同意目的阅读和理解英语
- 能够致力于研究干预和随访
- 能够参加THOR3教练带领的培训，不受限制
排除标准：
- 肥胖（体脂>25%）
- 心血管疾病
- 使用特定药物（例如他汀类药物、利尿剂、高血压药物）
- 女性
- 治疗区域（身体区域）的纹身
- 诊断为卟啉症（光诱发过敏）或光敏性湿疹
- 目前使用与热或光敏感相关的药物（例如胺碘酮、氯丙嗪、多西环素、氢氯噻嗪、萘啶酸、萘普生、吡罗昔康、四环素、硫利达嗪、伏立康唑）
- 使用起搏器/潜在心脏病
- 诊断患有自身免疫性疾病
- 白化病
- 周围神经病变
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
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假比较器：假手术PBMT
假 PBMT 的纳入将确保所有参与者的治疗程序保持相同，除了光子发射（主动治疗）之外，因此，允许将组之间的任何差异归因于 PBMT 的使用。
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Sham PBMT 将由经过培训的研究团队成员提供。
假 PBMT 将以与上述 PBMT 过程所示相同的方式进行，但设备将保持在待机模式（即，治疗模式不会打开）。
由于肉眼看不见红外光，治疗模式和待机模式之间唯一可见的区别是存在一些微小的琥珀色灯（这些灯在治疗模式期间亮起）。
其他名称：
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有源比较器：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.
其他名称：
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Countermovement Jump (CMJ) Initial Baseline: Concentric Impulse
大体时间：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.
大体时间：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)
大体时间：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
大体时间：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
大体时间：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.
|
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
大体时间：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.
|
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)
大体时间：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
大体时间：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
大体时间：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
大体时间：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)
大体时间：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
大体时间：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
大体时间：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
大体时间：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)
大体时间：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.
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Countermovement Jump (CMJ) Week 3 Follow-up: Time to Take-Off
大体时间：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
大体时间：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.
大体时间：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
大体时间：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
大体时间：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
大体时间：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.
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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)
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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.
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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 - Sleep Latency
大体时间：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 sleep latency (time taken to fall asleep in seconds).
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 - Sleep Efficiency Percentage
大体时间：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 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.
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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 - Sleep Quality Score
大体时间：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 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.
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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: Readiness Trends - Body Temperature Changes
大体时间：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 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.
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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 Data: Readiness Trends - Daily Heart Rate
大体时间：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 physical readiness trends, including changes in heart rate.
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: Readiness Trends - Heart Rate Variability (HRV)
大体时间：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 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.
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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: Readiness Trends - Respiration Rate
大体时间：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 physical readiness trends, including respiratory rate.
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: Readiness Trends - Blood Oxygen Saturation
大体时间：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
大体时间：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
大体时间：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.
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Body Measurements: Body Composition (% Body Fat)
大体时间：Measured prior to treatment starting at time of enrollment.
|
Biometrics
|
Measured prior to treatment starting at time of enrollment.
|
|
Body Measurements: Height (Inches)
大体时间：Measured prior to treatment starting at time of enrollment.
|
Biometrics
|
Measured prior to treatment starting at time of enrollment.
|
|
Body Measurements: Weight (Lbs)
大体时间：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)
大体时间：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)
大体时间：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)
大体时间：Measured prior to treatment starting at time of enrollment.
|
Biometrics - used to calculate PBMT dosage
|
Measured prior to treatment starting at time of enrollment.
|
其他结果措施
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
身体三围：身高（厘米）
大体时间：在入组时开始治疗之前测量。
|
生物识别技术
|
在入组时开始治疗之前测量。
|
|
身体测量：体重（公斤/磅）
大体时间：在入组时开始治疗之前测量。
|
生物识别技术
|
在入组时开始治疗之前测量。
|
|
身体测量：身体成分（体脂百分比）
大体时间：在入组时开始治疗之前测量。
|
生物识别技术
|
在入组时开始治疗之前测量。
|
|
身体测量：C1 - 大腿近端周长（厘米）
大体时间：在入组时开始治疗之前测量。
|
生物识别——用于计算 PBMT 剂量
|
在入组时开始治疗之前测量。
|
|
身体三围：C2 - 大腿远端周长（厘米）
大体时间：在入组时开始治疗之前测量。
|
生物识别——用于计算 PBMT 剂量
|
在入组时开始治疗之前测量。
|
|
身体三围：L1 - 大腿长度（厘米）
大体时间：在入组时开始治疗之前测量。
|
生物识别——用于计算 PBMT 剂量
|
在入组时开始治疗之前测量。
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
合作者
调查人员
- 首席研究员：Tanner Santarelli, DPT、1st Special Forces Group Tactical Human Optimization, Rapid Rehabilitation and Reconditioning (THOR3)
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
- 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.
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2025年1月23日
初级完成 (实际的)
2026年3月2日
研究完成 (实际的)
2026年3月2日
研究注册日期
首次提交
2024年3月13日
首先提交符合 QC 标准的
2024年4月18日
首次发布 (实际的)
2024年4月23日
研究记录更新
最后更新发布 (实际的)
2026年6月15日
上次提交的符合 QC 标准的更新
2026年5月18日
最后验证
2026年5月1日
更多信息
与本研究相关的术语
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
是的
IPD 计划说明
本研究的初始同意书 (ICF) 指出，去识别化的研究数据将与 MIRROR 和 USU 共享，并无限期保留，以便在未来的研究中可能使用。 通过同意参与这项研究，参与者同意允许我们无限期地保留他们的去识别化研究数据，以便在未来的研究中可能使用。
参与者将无法选择不让我们无限期保留其去识别化的研究数据以供将来使用。 ICF 指出，“如果您不希望在本研究中收集的去识别化数据用于未来的研究，则不应签署此同意书。”
IPD 共享支持信息类型
- 研究方案
- 树液
- 国际碳纤维联合会
- 分析代码
- 企业社会责任
药物和器械信息、研究文件
研究美国 FDA 监管的药品
不
研究美国 FDA 监管的设备产品
是的
在美国制造并从美国出口的产品
是的
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.