Assessing the Impact of Post-Exercise Photobiomodulation Application on Performance, Recovery, and Behavioral State in Trained Special Operator Population
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 116
- 试验地点
- 2
- 主要终点
- Countermovement Jump (CMJ) week 1 follow-up: deceleration/concentric impulse
研究概览
简要总结
Special Operations Forces (SOF) train continually to maintain peak performance. Thus, they are nearly always in a state of recovery, and in need of noninvasive therapies to address the taxing workload. Photobiomodulation therapy (PBMT) is a noninvasive treatment where a low-level laser is applied to the body to enhance healing, recovery, and performance. Army Tactical Human Optimization Rapid Rehabilitation and Reconditioning (THOR3) provides a consistent avenue for implementation of PBMT as a modality. Studies in athletes have shown performance and recovery benefits with pre-and post-workout focal application of PBMT. While there is less evidence on the potential cognitive/behavioral effects of a systematic application of PBMT, self-reported fatigue has also been found to be significantly lower in groups with focal PBMT application as compared to placebo. Further, PBMT research in healthy military tactical athletes is limited. PBMT may be a promising tool for enhancing physical performance by accelerating musculoskeletal and psychological recovery in the SOF population. The investigators aim to study the physiologic and behavioral effects of PBMT application post-exercise on performance in SOF Operators.
The Intent: The investigators propose to conduct a single-blinded randomized-control trial with sham control to investigate the effectiveness of providing PBMT post physical training in a SOF population.
The specific aims of this study are to:
- Analyze and describe the physiologic effects, if any, of PBMT application post-exercise in Special Forces Operators undergoing coach-led training.
- Analyze and describe the behavioral effects, if any, of PBMT application post-exercise in Special Forces Operators undergoing coach-led training.
- Evaluate the overall clinical utility of focal PBMT subsequent to physical training in a US Army SOF, tactical athlete population.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
盲法说明
In order to facilitate participant blinding to their randomized study group, all participants (regardless of their assigned study group) will be asked to wear blackout glasses and headphones during their treatment.
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Active-Duty Special Forces Personnel (18-series)
- •Able to read and understand English language for consent purposes
- •Able to commit to study intervention and follow-up
- •Able to participate in THOR3 coach-lead training, without restriction
排除标准
- •Obese (body fat > 25%)
- •Cardiovascular disease
- •Use of select medications (e.g., statins, diuretics, hypertensive agents)
- •Tattoo in treatment area (body region)
- •Diagnosis with porphyria (light induced allergy) or photosensitive eczema
- •Current use of medications associated with sensitivity to heat or light (e.g., amiodarone, chlorpromazine, doxycycline, hydrochlorothiazide, nalidixic acid, naproxen, piroxicam, tetracycline, thioridazine, voriconazole)
- •Use of pacemaker/underlying cardiac disease
- •Diagnosed with autoimmune disease(s)
- •Peripheral Neuropathy
结局指标
主要结局
Countermovement Jump (CMJ) week 1 follow-up: deceleration/concentric impulse
时间窗: Collected at the end of week 1 prior to coach-led training.
Assesses dynamic strength performance, including deceleration/concentric impulse via force plates and analysis software.
Countermovement Jump (CMJ) initial baseline: peak force production
时间窗: Collected prior to treatment starting at time of enrollment.
Assesses dynamic strength performance, including peak force production via force plates and analysis software.
Countermovement Jump (CMJ) initial baseline: rate of force production
时间窗: Collected prior to treatment starting at time of enrollment.
Assesses dynamic strength performance, including rate of force production via force plates and analysis software.
Countermovement Jump (CMJ) week 3 follow-up: deceleration/concentric impulse
时间窗: Collected at the end of week 3 prior to coach-led training.
Assesses dynamic strength performance, including deceleration/concentric impulse via force plates and analysis software.
Isometric Quadriceps Strength Testing 3-week follow-up
时间窗: Collected at the 3-week follow-up session prior to coach-led training.
Measuring isolated strength.
Defense and Veteran's Pain Rating Scale (DVPRS) daily reports
时间窗: Self-reported, daily from date of randomization through study completion after 3 weeks.
Captures subjective pain rating on a 0 - 10 scale (minimum - maximum; 0 = no pain, 10 = severe pain)
Borg Modified Rating of Perceived Exertion (RPE) 3-week follow-up
时间窗: Collected at the 3-week follow-up session after coach-led training and laser treatment.
Quantifying perceived exertion on 0-10 scale.
Countermovement Jump (CMJ) initial baseline: unilateral performance comparison
时间窗: Collected prior to treatment starting at time of enrollment.
Assesses dynamic strength performance, including comparisons between unilateral lower extremity performance via force plates and analysis software.
Countermovement Jump (CMJ) week 1 follow-up: unilateral performance comparison
时间窗: Collected at the end of week 1 prior to coach-led training.
Assesses dynamic strength performance, including comparisons between unilateral lower extremity performance via force plates and analysis software.
Countermovement Jump (CMJ) week 2 follow-up: deceleration/concentric impulse
时间窗: Collected at the end of week 2 prior to coach-led training.
Assesses dynamic strength performance, including deceleration/concentric impulse via force plates and analysis software.
Countermovement Jump (CMJ) week 2 follow-up: unilateral performance comparison
时间窗: Collected at the end of week 2 prior to coach-led training.
Assesses dynamic strength performance, including comparisons between unilateral lower extremity performance via force plates and analysis software.
Isokinetic Quadriceps Strength Testing initial baseline
时间窗: Collected prior to treatment starting at time of enrollment.
Measuring isolated strength.
Countermovement Jump (CMJ) week 1 follow-up: peak force production
时间窗: Collected at the end of week 1 prior to coach-led training.
Assesses dynamic strength performance, including peak force production via force plates and analysis software.
Countermovement Jump (CMJ) week 1 follow-up: rate of force production
时间窗: Collected at the end of week 1 prior to coach-led training.
Assesses dynamic strength performance, including rate of force production via force plates and analysis software.
Countermovement Jump (CMJ) week 2 follow-up: rate of force production
时间窗: Collected at the end of week 2 prior to coach-led training.
Assesses dynamic strength performance, including rate of force production via force plates and analysis software.
Countermovement Jump (CMJ) initial baseline: deceleration/concentric impulse
时间窗: Collected prior to treatment starting at time of enrollment.
Assesses dynamic strength performance, including deceleration/concentric impulse via force plates and analysis software.
Countermovement Jump (CMJ) week 2 follow-up: peak force production
时间窗: Collected at the end of week 2 prior to coach-led training.
Assesses dynamic strength performance, including peak force production via force plates and analysis software.
Isometric Quadriceps Strength Testing initial baseline
时间窗: Collected prior to treatment starting at time of enrollment.
Measuring isolated strength.
Isokinetic Hamstrings Strength Testing initial baseline
时间窗: Collected prior to treatment starting at time of enrollment.
Measuring isolated strength.
Countermovement Jump (CMJ) week 3 follow-up: peak force production
时间窗: Collected at the end of week 3 prior to coach-led training.
Assesses dynamic strength performance, including peak force production via force plates and analysis software.
Countermovement Jump (CMJ) week 3 follow-up: rate of force production
时间窗: Collected at the end of week 3 prior to coach-led training.
Assesses dynamic strength performance, including rate of force production via force plates and analysis software.
Countermovement Jump (CMJ) week 3 follow-up: unilateral performance comparison
时间窗: Collected at the end of week 3 prior to coach-led training.
Assesses dynamic strength performance, including comparisons between unilateral lower extremity performance via force plates and analysis software.
Isometric Hamstrings Strength Testing initial baseline
时间窗: Collected prior to treatment starting at time of enrollment.
Measuring isolated strength.
Isometric Hamstrings Strength Testing 3-week follow-up
时间窗: Collected at the 3-week follow-up session prior to coach-led training.
Measuring isolated strength.
Defense and Veteran's Pain Rating Scale (DVPRS) initial baseline
时间窗: Self-reported, daily from date of randomization through study completion after 3 weeks.
Captures subjective pain rating on a 0 - 10 scale (minimum - maximum; 0 = no pain, 10 = severe pain)
Oura Ring Sleep Data: sleep metrics - time in bed
时间窗: Oura data is collected from daily wear of ring from date of randomization through study completion after 3 weeks.
Oura Ring will continuously measure aspects of sleep, including time spent in bed.
Oura Ring Sleep Data: Readiness trends - readiness score
时间窗: 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 - calculated from multiple other aspects of sleep data and readiness trends.
Isokinetic Quadriceps Strength Testing 3-week follow-up
时间窗: Collected at the 3-week follow-up session prior to coach-led training.
Measuring isolated strength.
Isokinetic Hamstrings Strength Testing 3-week follow-up
时间窗: Collected at the 3-week follow-up session prior to coach-led training.
Measuring isolated strength.
Elloumi fatigue scale 3-week follow-up
时间窗: Collected at the 3-week follow-up session after coach-led training and laser treatment.
Behavioral health rating of fatigue. The short questionnaire of fatigue uses eight questions that highlight perception of training difficulty, sleep, leg discomfort, infection/colds, concentration, work efficacy, anxiety and overall stress. Each question is rated by the respondent on a 7-point scale: 1 point (not at all) to 7 points (very much). The summed total score of the 8 questions allows for a total score of fatigue (TSF). Total score of fatigue ranges from 8 points (not at all fatigued) to 56 points (very much fatigued).
Quick Physical Activity Rating scale (QPAR)
时间窗: Collected prior to treatment starting at time of enrollment.
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.
Oura Ring Sleep Data: sleep metrics - sleep duration
时间窗: Oura data is collected from daily wear of ring from date of randomization through study completion after 3 weeks.
Oura Ring will continuously measure aspects of sleep, including duration of sleep.
Oura Ring Sleep Data: sleep metrics - light sleep length
时间窗: Oura data is collected from daily wear of ring from date of randomization through study completion after 3 weeks.
Oura Ring will continuously measure aspects of sleep, including duration of light sleep stage.
Oura Ring Sleep Data: sleep metrics - sleep efficiency score
时间窗: 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 score.
Elloumi fatigue scale initial baseline
时间窗: Collected prior to treatment starting at time of enrollment.
Behavioral health rating of fatigue. The short questionnaire of fatigue uses eight questions that highlight perception of training difficulty, sleep, leg discomfort, infection/colds, concentration, work efficacy, anxiety and overall stress. Each question is rated by the respondent on a 7-point scale: 1 point (not at all) to 7 points (very much). The summed total score of the 8 questions allows for a total score of fatigue (TSF). Total score of fatigue ranges from 8 points (not at all fatigued) to 56 points (very much fatigued).
Visual Analog Scale (VAS) initial baseline
时间窗: Collected prior to treatment starting at time of enrollment.
Measures delayed onset muscle soreness. Respondents mark on a 10 centimeter line their current level of muscle soreness. The left end of the line represents "I feel no soreness in my muscles" and the right end represents "My muscles feel so sore, I don't want to move them."
Visual Analog Scale (VAS) week 1 follow-up
时间窗: Collected at the end of week 1 after coach-led training and laser treatment.
Measures delayed onset muscle soreness. Respondents mark on a 10 centimeter line their current level of muscle soreness. The left end of the line represents "I feel no soreness in my muscles" and the right end represents "My muscles feel so sore, I don't want to move them."
Visual Analog Scale (VAS) week 2 follow-up
时间窗: Collected at the end of week 2 after coach-led training and laser treatment.
Measures delayed onset muscle soreness. Respondents mark on a 10 centimeter line their current level of muscle soreness. The left end of the line represents "I feel no soreness in my muscles" and the right end represents "My muscles feel so sore, I don't want to move them."
Borg Modified Rating of Perceived Exertion (RPE) initial baseline
时间窗: Collected prior to treatment starting at time of enrollment
Quantifying perceived exertion on 0-10 scale.
Oura Ring Sleep Data: sleep metrics - rapid eye movement (REM) sleep length
时间窗: Oura data is collected from daily wear of ring from date of randomization through study completion after 3 weeks.
Oura Ring will continuously measure aspects of sleep, including duration of REM sleep stage.
Oura Ring Sleep Data: sleep metrics - sleep latency
时间窗: 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).
Oura Ring Sleep Data: Readiness trends - heart rate changes
时间窗: 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.
Oura Ring Sleep Data: Readiness trends - blood oxygen saturation
时间窗: 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.
Visual Analog Scale (VAS) week 3 follow-up
时间窗: Collected at the end of week 3 after coach-led training and laser treatment.
Measures delayed onset muscle soreness. Respondents mark on a 10 centimeter line their current level of muscle soreness. The left end of the line represents "I feel no soreness in my muscles" and the right end represents "My muscles feel so sore, I don't want to move them."
Oura Ring Sleep Data: Readiness trends - respiration rate
时间窗: 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.
Oura Ring Sleep Data: sleep metrics - deep sleep length
时间窗: Oura data is collected from daily wear of ring from date of randomization through study completion after 3 weeks.
Oura Ring will continuously measure aspects of sleep, including duration of deep sleep stage.
Oura Ring Sleep Data: sleep metrics - sleep quality score
时间窗: 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.
Oura Ring Sleep Data: Readiness trends - body temperature changes
时间窗: 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 body temperature.
Oura Ring Sleep Data: Readiness trends - heart rate variability (HRV)
时间窗: 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.
Oura Ring Sleep Data: Readiness trends - sleep regularity
时间窗: 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 regularity - a measure of consistency of bedtime, wake-time and duration sleep over a period of time.
次要结局
未报告次要终点