이 페이지는 자동 번역되었으며 번역의 정확성을 보장하지 않습니다. 참조하십시오 영문판 원본 텍스트의 경우.

광의학 프로젝트 14: SOF의 성능 향상을 위한 PBMT (SOF)

훈련된 특수 운영자 모집단의 성능, 회복 및 행동 상태에 대한 운동 후 광생체 변조 적용의 영향 평가

특수작전부대(SOF)는 최고의 성능을 유지하기 위해 지속적으로 훈련합니다. 따라서 그들은 거의 항상 회복 상태에 있으며, 부담스러운 업무량을 해결하기 위해 비침습적 치료법이 필요합니다. 광생체변조치료(PBMT)는 낮은 수준의 레이저를 신체에 적용하여 치유, 회복 및 성능을 향상시키는 비침습적 치료법입니다. 육군 전술 인간 최적화 신속 재활 및 재조정(THOR3)은 PBMT를 양식으로 구현하기 위한 일관된 방법을 제공합니다. 운동선수를 대상으로 한 연구에서는 운동 전후에 PBMT를 집중적으로 적용하면 성능과 회복 효과가 있는 것으로 나타났습니다. PBMT의 체계적인 적용이 잠재적인 인지/행동 효과에 대한 증거는 적지만, 자가 보고 피로도 위약에 비해 국소 PBMT 적용 그룹에서 유의하게 낮은 것으로 밝혀졌습니다. 또한 건강한 군사 전술 운동선수에 대한 PBMT 연구는 제한적입니다. PBMT는 SOF 인구의 근골격 및 심리적 회복을 가속화하여 신체적 성능을 향상시키는 유망한 도구가 될 수 있습니다. 연구자들은 SOF 운영자의 수행 능력에 대한 운동 후 PBMT 적용의 생리적 및 행동적 효과를 연구하는 것을 목표로 합니다.

의도: 조사관은 SOF 모집단에서 PBMT 후 신체 훈련 제공의 효과를 조사하기 위해 가짜 통제를 사용하는 단일 맹검 무작위 대조 시험을 수행할 것을 제안합니다.

이 연구의 구체적인 목표는 다음과 같습니다.

  1. 코치 주도 훈련을 받는 특수 부대 대원의 운동 후 PBMT 적용의 생리학적 효과를 분석하고 설명합니다.
  2. 코치 주도 훈련을 받는 특수 부대 대원의 운동 후 PBMT 적용의 행동 효과를 분석하고 설명합니다.
  3. 미 육군 SOF 전술 운동선수 모집단의 신체 훈련 이후 초점 PBMT의 전반적인 임상적 유용성을 평가합니다.

연구 개요

연구 유형

중재적

등록 (실제)

29

단계

  • 해당 없음

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

    • Washington
      • Joint Base Lewis McChord, Washington, 미국, 98433
        • Joint Base Lewis-McChord

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

  • 성인

건강한 자원 봉사자를 받아들입니다

설명

포함 기준:

  • 현역 특수부대 요원(18 시리즈)
  • 동의 목적으로 영어를 읽고 이해할 수 있습니다.
  • 연구 개입 및 후속 조치에 전념할 수 있음
  • THOR3 코치리드 교육에 제한 없이 참여 가능

제외 기준:

  • 비만(체지방 > 25%)
  • 심혈관 질환
  • 특정 약물(예: 스타틴, 이뇨제, 고혈압제) 사용
  • 여성
  • 시술 부위 문신 (신체 부위)
  • 포르피린증(광 유발 알레르기) 또는 감광성 습진으로 진단
  • 열이나 빛에 대한 민감성과 관련된 약물의 현재 사용(예: 아미오다론, 클로르프로마진, 독시사이클린, 히드로클로로티아지드, 날리딕스산, 나프록센, 피록시캄, 테트라사이클린, 티오리다진, 보리코나졸)
  • 심박조율기 사용/기저 심장질환
  • 자가면역질환으로 진단됨
  • 백색증
  • 말초 신경증

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 하나의

무기와 개입

참가자 그룹 / 팔
개입 / 치료
가짜 비교기: 가짜 PBMT
가짜 PBMT를 포함하면 광자 방출(활성 치료)을 제외하고 모든 참가자 치료 절차가 동일하게 유지되므로 그룹 간의 차이가 PBMT 사용으로 인정될 수 있습니다.
가짜 PBMT는 훈련된 연구 팀 구성원에 의해 제공됩니다. 가짜 PBMT는 위의 PBMT 프로세스에 표시된 것과 동일한 방식으로 전달되지만 장치는 대기 모드로 유지됩니다(즉, 치료 모드가 켜지지 않음). 적외선은 육안으로 볼 수 없기 때문에 치료 모드와 대기 모드 사이에서 눈에 보이는 유일한 차이점은 몇 개의 작은 호박색 표시등이 있다는 것입니다(이 표시등은 치료 모드 중에 켜집니다).
다른 이름들:
  • THOR3 훈련 + 위약
활성 비교기: Photobiomodulation Treatment (PBMT)
PBMT will be delivered at 40 watts (W). PBMT will be applied to the quadriceps area. A study team member will use the quadriceps measurements of the treatment area to calculate the PBMT treatment time (approximately 5-20 minutes) and specified J/cm2. PBMT treatment will be provided 3 times per week, for 3 weeks.

PBMT will be delivered at 40W (depending on participant skin pigmentation). PBMT will be applied to the quadriceps area. A study team member will use the quadriceps measurements of the treatment area to calculate the PBMT treatment time (approximately 5-20 minutes) and specified J/cm2. PBMT treatment will be provided 3 times per week, for 3 weeks.

PBMT will be delivered by a trained study team member using the LightForce® XLi 40W device with the Smart Hand Piece technology, which has a built-in accelerometer in the hand piece that controls the speed of light delivery to the treatment area. The trained team members will use the Smart Hand Piece technology, which assesses the operator's speed and provides real-time visual and sensory feedback calibrated to shut-off when moving too slowly and warns the operator when moving too quickly by vibrating. Treatment is delivered through a flexible optical fiber threaded through the hand piece, which contains a rolling glass massage ball.

다른 이름들:
  • 저수준 레이저 치료(LLLT)
  • LightForce® XLi

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Countermovement Jump (CMJ) Initial Baseline: Concentric Impulse
기간: Collected prior to treatment starting at time of enrollment.
Assesses dynamic strength performance, including concentric impulse via force plates and analysis software.
Collected prior to treatment starting at time of enrollment.
Countermovement Jump (CMJ) Initial Baseline: Movement Start to Peak Power.
기간: Collected prior to treatment starting at time of enrollment.
Assesses dynamic strength performance, including Movement start to peak power. via force plates and analysis software.
Collected prior to treatment starting at time of enrollment.
Countermovement Jump (CMJ) Initial Baseline: Reactive Strength Index-modified (RSImod)
기간: Collected prior to treatment starting at time of enrollment.

Assesses dynamic strength performance, including Reactive Strength Index-modified (RSImod) via force plates and analysis software. Reactive Strength Index-modified (RSImod) reflects the efficiency of force production during a countermovement jump. It is calculated as jump height divided by time to take-off. Higher values indicate better explosive performance and lower neuromuscular fatigue, whereas lower values indicate reduced efficiency or increased fatigue. The index ranges from 0 upward with no theoretical maximum; therefore, interpretation should rely on normative ranges or athlete-specific baselines.

Reference categories:

Lower performers (L): ~0.20-0.30

Moderate performers (M): ~0.30-0.45

Upper performers (U): ~0.45-0.70+

Collected prior to treatment starting at time of enrollment.
Countermovement Jump (CMJ) Initial Baseline: Time to Take-Off
기간: Collected prior to treatment starting at time of enrollment.
Assesses dynamic strength performance, including Time to Take-Off via force plates and analysis software.
Collected prior to treatment starting at time of enrollment.
Countermovement Jump (CMJ) Week 1 Follow-up: Concentric Impulse
기간: Collected at the end of week 1 prior to coach-led training.
Assesses dynamic strength performance, including concentric impulse via force plates and analysis software.
Collected at the end of week 1 prior to coach-led training.
Countermovement Jump (CMJ) Week 1 Follow-up: Movement Start to Peak Power
기간: Collected at the end of week 1 prior to coach-led training.
Assesses dynamic strength performance, including Movement Start to peak Power via force plates and analysis software.
Collected at the end of week 1 prior to coach-led training.
Countermovement Jump (CMJ) Week 1 Follow-up: Reactive Strength Index-modified (RSImod)
기간: Collected at the end of week 1 prior to coach-led training.

Assesses dynamic strength performance, including Reactive Strength Index-modified (RSImod) via force plates and analysis software. Reactive Strength Index-modified (RSImod) reflects the efficiency of force production during a countermovement jump. It is calculated as jump height divided by time to take-off. Higher values indicate better explosive performance and lower neuromuscular fatigue, whereas lower values indicate reduced efficiency or increased fatigue. The index ranges from 0 upward with no theoretical maximum; therefore, interpretation should rely on normative ranges or athlete-specific baselines.

Reference categories:

Lower performers (L): ~0.20-0.30

Moderate performers (M): ~0.30-0.45

Upper performers (U): ~0.45-0.70+

Collected at the end of week 1 prior to coach-led training.
Countermovement Jump (CMJ) Week 1 Follow-up: Time to Take-Off
기간: Collected at the end of week 1 prior to coach-led training.
Assesses dynamic strength performance, including Time to Take-Off via force plates and analysis software.
Collected at the end of week 1 prior to coach-led training.
Countermovement Jump (CMJ) Week 2 Follow-up: Concentric Impulse
기간: Collected at the end of week 2 prior to coach-led training.
Assesses dynamic strength performance, including concentric impulse via force plates and analysis software.
Collected at the end of week 2 prior to coach-led training.
Countermovement Jump (CMJ) Week 2 Follow-up: Movement Start to Peak Power
기간: Collected at the end of week 2 prior to coach-led training.
Assesses dynamic strength performance, including peak force production via force plates and analysis software.
Collected at the end of week 2 prior to coach-led training.
Countermovement Jump (CMJ) Week 2 Follow-up: Reactive Strength Index-modified (RSImod)
기간: Collected at the end of week 2 prior to coach-led training.

Assesses dynamic strength performance, including Reactive Strength Index-modified (RSImod) via force plates and analysis software. Reactive Strength Index-modified (RSImod) reflects the efficiency of force production during a countermovement jump. It is calculated as jump height divided by time to take-off. Higher values indicate better explosive performance and lower neuromuscular fatigue, whereas lower values indicate reduced efficiency or increased fatigue. The index ranges from 0 upward with no theoretical maximum; therefore, interpretation should rely on normative ranges or athlete-specific baselines.

Reference categories:

Lower performers (L): ~0.20-0.30

Moderate performers (M): ~0.30-0.45

Upper performers (U): ~0.45-0.70+

Collected at the end of week 2 prior to coach-led training.
Countermovement Jump (CMJ) Week 2 Follow-up: Time to Take-Off
기간: Collected at the end of week 2 prior to coach-led training.
Assesses dynamic strength performance, including Time to Take-Off via force plates and analysis software.
Collected at the end of week 2 prior to coach-led training.
Countermovement Jump (CMJ) Week 3 Follow-up: Concentric Impulse
기간: Collected at the end of week 3 prior to coach-led training.
Assesses dynamic strength performance, including concentric impulse via force plates and analysis software.
Collected at the end of week 3 prior to coach-led training.
Countermovement Jump (CMJ) Week 3 Follow-up: Movement Start to Peak Power
기간: Collected at the end of week 3 prior to coach-led training.
Assesses dynamic strength performance, including peak force production via force plates and analysis software.
Collected at the end of week 3 prior to coach-led training.
Countermovement Jump (CMJ) Week 3 Follow-up: Reactive Strength Index-modified (RSImod)
기간: Collected at the end of week 3 prior to coach-led training.

Assesses dynamic strength performance, including Reactive Strength Index-modified (RSImod) via force plates and analysis software. Reactive Strength Index-modified (RSImod) reflects the efficiency of force production during a countermovement jump. It is calculated as jump height divided by time to take-off. Higher values indicate better explosive performance and lower neuromuscular fatigue, whereas lower values indicate reduced efficiency or increased fatigue. The index ranges from 0 upward with no theoretical maximum; therefore, interpretation should rely on normative ranges or athlete-specific baselines.

Reference categories:

Lower performers (L): ~0.20-0.30

Moderate performers (M): ~0.30-0.45

Upper performers (U): ~0.45-0.70+

Collected at the end of week 3 prior to coach-led training.
Countermovement Jump (CMJ) Week 3 Follow-up: Time to Take-Off
기간: Collected at the end of week 3 prior to coach-led training.
Assesses dynamic strength performance, including Time to Take-Off via force plates and analysis software.
Collected at the end of week 3 prior to coach-led training.
Isometric Quadriceps Strength Testing Initial Baseline: Peak Torque
기간: Collected prior to treatment starting at time of enrollment.
Measuring isolated strength (Peak Torque).
Collected prior to treatment starting at time of enrollment.
Isometric Hamstrings Strength Testing Initial Baseline: Peak Torque.
기간: Collected prior to treatment starting at time of enrollment.
Measuring isolated strength (Peak Torque).
Collected prior to treatment starting at time of enrollment.
Isokinetic Quadriceps Strength Testing Initial Baseline: Peak Torque
기간: Collected prior to treatment starting at time of enrollment.
Measuring isolated strength (Peak Torque).
Collected prior to treatment starting at time of enrollment.
Isokinetic Hamstrings Strength Testing Initial Baseline: Peak Torque
기간: Collected prior to treatment starting at time of enrollment.
Measuring isolated strength (Peak Torque).
Collected prior to treatment starting at time of enrollment.
Isometric Quadriceps Strength Testing 3-week Follow-up: Peak Torque
기간: Collected at the 3-week follow-up session prior to coach-led training.
Measuring isolated strength (Peak Torque).
Collected at the 3-week follow-up session prior to coach-led training.
Isometric Hamstrings Strength Testing 3-week Follow-up: Peak Torque.
기간: Collected at the 3-week follow-up session prior to coach-led training.
Measuring isolated strength (Peak Torque).
Collected at the 3-week follow-up session prior to coach-led training.
Isokinetic Quadriceps Strength Testing 3-week Follow-up: Peak Torque
기간: Collected at the 3-week follow-up session prior to coach-led training.
Measuring isolated strength (Peak Torque).
Collected at the 3-week follow-up session prior to coach-led training.
Isokinetic Hamstrings Strength Testing 3-week Follow-up: Peak Torque
기간: Collected at the 3-week follow-up session prior to coach-led training.
Measuring isolated strength (Peak Torque).
Collected at the 3-week follow-up session prior to coach-led training.
Defense and Veteran's Pain Rating Scale (DVPRS) Initial Baseline
기간: Self-reported at baseline
Captures subjective pain rating on a 0 - 10 scale (minimum - maximum; 0 = no pain, 10 = severe pain). Higher scores equal worse outcomes.
Self-reported at baseline
Defense and Veteran's Pain Rating Scale (DVPRS) Daily Reports
기간: Self-reported, daily after baseline through study completion after 3 weeks.
Captures subjective pain rating on a 0 - 10 scale (minimum - maximum; 0 = no pain, 10 = severe pain). Higher scores equals worse outcomes. Calculation for this timepoint was dervied from averaging all daily pain scores into an aggregate value.
Self-reported, daily after baseline through study completion after 3 weeks.
Visual Analog Scale (VAS) Initial Baseline
기간: Collected prior to treatment starting at time of enrollment.
Measures delayed onset muscle soreness. Respondents mark on a 10 centimeter line their current level of muscle soreness. The left end of the line represents "I feel no soreness in my muscles" and the right end represents "My muscles feel so sore, I don't want to move them." Scores range from 0-100, with higher scores equaling worse outcomes.
Collected prior to treatment starting at time of enrollment.
Visual Analog Scale (VAS) Week 1 Follow-up
기간: Collected at the end of week 1 after coach-led training and laser treatment.
Measures delayed onset muscle soreness. Respondents mark on a 10 centimeter line their current level of muscle soreness. The left end of the line represents "I feel no soreness in my muscles" and the right end represents "My muscles feel so sore, I don't want to move them." Scores range from 0-100, with higher scores equaling worse outcomes.
Collected at the end of week 1 after coach-led training and laser treatment.
Visual Analog Scale (VAS) Week 2 Follow-up
기간: Collected at the end of week 2 after coach-led training and laser treatment.
Measures delayed onset muscle soreness. Respondents mark on a 10 centimeter line their current level of muscle soreness. The left end of the line represents "I feel no soreness in my muscles" and the right end represents "My muscles feel so sore, I don't want to move them." Scores range from 0-100, with higher scores equaling worse outcomes.
Collected at the end of week 2 after coach-led training and laser treatment.
Visual Analog Scale (VAS) Week 3 Follow-up
기간: Collected at the end of week 3 after coach-led training and laser treatment.
Measures delayed onset muscle soreness. Respondents mark on a 10 centimeter line their current level of muscle soreness. The left end of the line represents "I feel no soreness in my muscles" and the right end represents "My muscles feel so sore, I don't want to move them." Scores range from 0-100, with higher scores equaling worse outcomes.
Collected at the end of week 3 after coach-led training and laser treatment.
Borg Modified Rating of Perceived Exertion (RPE) Initial Baseline
기간: Collected prior to treatment starting at time of enrollment
Quantifying perceived exertion on 0-10 scale. Higher scores indicate worse outcomes.
Collected prior to treatment starting at time of enrollment
Borg Modified Rating of Perceived Exertion (RPE) 3-week Follow-up
기간: Collected at the 3-week follow-up session after coach-led training and laser treatment.
Quantifying perceived exertion on 0-10 scale. Higher scores indicate worse outcomes.
Collected at the 3-week follow-up session after coach-led training and laser treatment.
Elloumi Fatigue Scale Initial Baseline
기간: Collected prior to treatment starting at time of enrollment.
Behavioral health rating of fatigue. The short questionnaire of fatigue uses eight questions that highlight perception of training difficulty, sleep, leg discomfort, infection/colds, concentration, work efficacy, anxiety and overall stress. Each question is rated by the respondent on a 7-point scale: 1 point (not at all) to 7 points (very much). The summed total score of the 8 questions allows for a total score of fatigue (TSF). Total score of fatigue ranges from 8 points (not at all fatigued) to 56 points (very much fatigued).
Collected prior to treatment starting at time of enrollment.
Elloumi Fatigue Scale 3-week Follow-up
기간: Collected at the 3-week follow-up session after coach-led training and laser treatment.
Behavioral health rating of fatigue. The short questionnaire of fatigue uses eight questions that highlight perception of training difficulty, sleep, leg discomfort, infection/colds, concentration, work efficacy, anxiety and overall stress. Each question is rated by the respondent on a 7-point scale: 1 point (not at all) to 7 points (very much). The summed total score of the 8 questions allows for a total score of fatigue (TSF). Total score of fatigue ranges from 8 points (not at all fatigued) to 56 points (very much fatigued).
Collected at the 3-week follow-up session after coach-led training and laser treatment.
Quick Physical Activity Rating Scale (QPAR)
기간: Collected prior to treatment starting at time of enrollment.
Higher scores indicate better outcome. Scaled rating of various types of physical activity participation. Respondent reporting quantifies the overall amount of physical activity that the respondent regularly engages in. Activities are weighted in intensity that ranges from 1 (light) to 3 (heavy). Activity weekly frequency reported as never (0 days), seldom (1-2 days), sometime (3-4 days), and often (5-7 days). Activity duration collected as less than one hour per day, 1-2 hours per day, and more than two hours per day. Intensity (1-3), frequency (0-3) and duration (1-3) scores are multiplied and provide a physical activity score that may range from 0 - 153 points, 0 being very low physical activity and 153 representing very high physical activity.
Collected prior to treatment starting at time of enrollment.
Oura Ring Sleep Data: Sleep Metrics - Sleep Duration
기간: Oura data is collected from daily wear of ring from date of randomization through study completion after 3 weeks.
Oura Ring will continuously measure aspects of sleep, including duration of sleep. Calculation for this measure was dervied from averaging all daily sleep scores into an aggregate value.
Oura data is collected from daily wear of ring from date of randomization through study completion after 3 weeks.
Oura Ring Sleep Data: Sleep Metrics - Time in Bed
기간: Oura data is collected from daily wear of ring from date of randomization through study completion after 3 weeks.
Oura Ring will continuously measure aspects of sleep, including time spent in bed. Calculation for this measure was dervied from averaging all daily scores into an aggregate value.
Oura data is collected from daily wear of ring from date of randomization through study completion after 3 weeks.
Oura Ring Sleep Data: Sleep Metrics - Light Sleep Length
기간: Oura data is collected from daily wear of ring from date of randomization through study completion after 3 weeks.
Oura Ring will continuously measure aspects of sleep, including duration of light sleep stage. Calculation for this measure was dervied from averaging all daily scores into an aggregate value.
Oura data is collected from daily wear of ring from date of randomization through study completion after 3 weeks.
Oura Ring Sleep Data: Sleep Metrics - Rapid Eye Movement (REM) Sleep Length
기간: Oura data is collected from daily wear of ring from date of randomization through study completion after 3 weeks.
Oura Ring will continuously measure aspects of sleep, including duration of REM sleep stage. Calculation for this measure was dervied from averaging all daily scores into an aggregate value.
Oura data is collected from daily wear of ring from date of randomization through study completion after 3 weeks.
Oura Ring Sleep Data: Sleep Metrics - Deep Sleep Length
기간: Oura data is collected from daily wear of ring from date of randomization through study completion after 3 weeks.
Oura Ring will continuously measure aspects of sleep, including duration of deep sleep stage (seconds). Calculation for this measure was dervied from averaging all daily scores into an aggregate value.
Oura data is collected from daily wear of ring from date of randomization through study completion after 3 weeks.
Oura Ring Sleep Data: Sleep Metrics - Sleep Latency
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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)
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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.

2차 결과 측정

결과 측정
측정값 설명
기간
Body Measurements: Body Composition (% Body Fat)
기간: Measured prior to treatment starting at time of enrollment.
Biometrics
Measured prior to treatment starting at time of enrollment.
Body Measurements: Height (Inches)
기간: Measured prior to treatment starting at time of enrollment.
Biometrics
Measured prior to treatment starting at time of enrollment.
Body Measurements: Weight (Lbs)
기간: 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)
기간: 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)
기간: 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)
기간: Measured prior to treatment starting at time of enrollment.
Biometrics - used to calculate PBMT dosage
Measured prior to treatment starting at time of enrollment.

기타 결과 측정

결과 측정
측정값 설명
기간
신체 치수: 신장(cm)
기간: 등록 시점부터 치료를 시작하기 전에 측정되었습니다.
생체 인식
등록 시점부터 치료를 시작하기 전에 측정되었습니다.
신체 측정: 체중(kg/lbs)
기간: 등록 시점부터 치료를 시작하기 전에 측정되었습니다.
생체 인식
등록 시점부터 치료를 시작하기 전에 측정되었습니다.
신체 측정: 신체 구성(% 체지방)
기간: 등록 시점부터 치료를 시작하기 전에 측정되었습니다.
생체 인식
등록 시점부터 치료를 시작하기 전에 측정되었습니다.
신체 측정: C1 - 근위 허벅지 둘레(cm)
기간: 등록 시점부터 치료를 시작하기 전에 측정되었습니다.
생체 인식 - PBMT 복용량을 계산하는 데 사용됩니다.
등록 시점부터 치료를 시작하기 전에 측정되었습니다.
신체 측정: C2 - 허벅지 원위 둘레(cm)
기간: 등록 시점부터 치료를 시작하기 전에 측정되었습니다.
생체 인식 - PBMT 복용량을 계산하는 데 사용됩니다.
등록 시점부터 치료를 시작하기 전에 측정되었습니다.
신체 치수: L1 - 허벅지 길이(cm)
기간: 등록 시점부터 치료를 시작하기 전에 측정되었습니다.
생체 인식 - PBMT 복용량을 계산하는 데 사용됩니다.
등록 시점부터 치료를 시작하기 전에 측정되었습니다.

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

수사관

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

간행물 및 유용한 링크

연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.

일반 간행물

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2025년 1월 23일

기본 완료 (실제)

2026년 3월 2일

연구 완료 (실제)

2026년 3월 2일

연구 등록 날짜

최초 제출

2024년 3월 13일

QC 기준을 충족하는 최초 제출

2024년 4월 18일

처음 게시됨 (실제)

2024년 4월 23일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 6월 15일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 5월 18일

마지막으로 확인됨

2026년 5월 1일

추가 정보

이 연구와 관련된 용어

기타 연구 ID 번호

  • USUHS.2023-126

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

IPD 계획 설명

본 연구에 대한 초기 동의서(ICF)에는 식별되지 않은 연구 데이터가 MIRROR 및 USU와 공유되고 향후 연구에 사용할 수 있도록 무기한 유지된다는 내용이 명시되어 있습니다. 본 연구에 참여하는 데 동의함으로써 참가자는 당사가 향후 연구에 사용할 수 있도록 식별되지 않은 연구 데이터를 무기한 유지하는 데 동의합니다.

참가자에게는 향후 사용을 위해 식별되지 않은 연구 데이터를 무기한 보관하는 것을 거부할 수 있는 옵션이 제공되지 않습니다. ICF는 "이 연구의 일부로 수집된 귀하의 식별되지 않은 데이터가 향후 연구에 사용되기 위해 보관되는 것을 원하지 않는 경우 이 동의서에 서명하지 마십시오"라고 명시합니다.

IPD 공유 지원 정보 유형

  • 연구_프로토콜
  • 수액
  • ICF
  • ANALYTIC_CODE
  • CSR

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

미국에서 제조되어 미국에서 수출되는 제품

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

THOR3 훈련 + 가짜 PBMT에 대한 임상 시험

구독하다