- ICH GCP
- Yhdysvaltain kliinisten tutkimusten rekisteri
- Kliininen tutkimus NCT06380179
Photomedicine Project 14: PBMT suorituskyvyn parantamiseksi SOF:ssa (SOF)
Harjoituksen jälkeisen fotobiomodulaatiosovelluksen vaikutuksen arviointi suorituskykyyn, palautumiseen ja käyttäytymistilaan koulutetussa erikoisoperaattoripopulaatiossa
Special Operations Forces (SOF) harjoittelee jatkuvasti ylläpitääkseen huippusuorituskykyään. Näin ollen he ovat lähes aina toipumassa ja tarvitsevat ei-invasiivisia hoitoja rasittavan työtaakan hoitamiseksi. Valobiomodulaatiohoito (PBMT) on ei-invasiivinen hoito, jossa matalan tason laseria käytetään kehoon parantamaan paranemista, palautumista ja suorituskykyä. Army Tactical Human Optimization Rapid Rehabilitation and Reconditioning (THOR3) tarjoaa johdonmukaisen väylän PBMT:n toteuttamiseen modaliteettina. Urheilijoilla tehdyt tutkimukset ovat osoittaneet suorituskyvyn ja palautumisen hyödyt ennen harjoittelua ja sen jälkeen suoritetulla PBMT:llä. Vaikka PBMT:n systemaattisen käytön mahdollisista kognitiivisista/käyttäytymisvaikutuksista on vähemmän näyttöä, itse ilmoittaman väsymyksen on myös havaittu olevan merkittävästi pienempi ryhmissä, joilla on fokaalinen PBMT-sovellus, verrattuna lumelääkkeeseen. Lisäksi PBMT-tutkimus terveillä armeijan taktisilla urheilijoilla on rajallista. PBMT voi olla lupaava työkalu fyysisen suorituskyvyn parantamiseen nopeuttamalla tuki- ja liikuntaelimistön sekä psyykkistä palautumista SOF-populaatiossa. Tutkijoiden tavoitteena on tutkia PBMT-sovelluksen fysiologisia ja käyttäytymiseen liittyviä vaikutuksia harjoituksen jälkeen suorituskykyyn SOF-operaattoreissa.
Tarkoitus: Tutkijat ehdottavat yksisokkoutetun satunnaistetun kontrollitutkimuksen suorittamista valekontrollilla tutkiakseen PBMT:n jälkeisen fyysisen harjoittelun tehokkuutta SOF-populaatiossa.
Tämän tutkimuksen erityistavoitteet ovat:
- Analysoi ja kuvaile PBMT-sovelluksen mahdolliset fysiologiset vaikutukset harjoituksen jälkeen valmentajan johtaman koulutuksen saavilla erikoisjoukkojen operaattoreilla.
- Analysoi ja kuvaile PBMT-sovelluksen mahdolliset käyttäytymisvaikutukset harjoituksen jälkeen valmentajan johtamassa koulutuksessa olevissa erikoisjoukkojen operaattoreissa.
- Arvioi fokaalisen PBMT:n yleistä kliinistä hyötyä fyysisen harjoittelun jälkeen Yhdysvaltain armeijan SOF:ssa, taktisessa urheilijapopulaatiossa.
Tutkimuksen yleiskatsaus
Tila
Ehdot
Opintotyyppi
Ilmoittautuminen (Todellinen)
Vaihe
- Ei sovellettavissa
Yhteystiedot ja paikat
Opiskelupaikat
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Washington
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Joint Base Lewis McChord, Washington, Yhdysvallat, 98433
- Joint Base Lewis-McChord
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Osallistumiskriteerit
Kelpoisuusvaatimukset
Opintokelpoiset iät
- Aikuinen
Hyväksyy terveitä vapaaehtoisia
Kuvaus
Sisällyttämiskriteerit:
- Erikoisjoukkojen aktiivihenkilöstö (18-sarja)
- Pystyy lukemaan ja ymmärtämään englannin kieltä suostumustarkoituksiin
- Pystyy sitoutumaan tutkimaan interventiota ja seurantaa
- Pystyy osallistumaan THOR3-valmentajan johtokoulutukseen ilman rajoituksia
Poissulkemiskriteerit:
- Liikalihava (kehon rasvaa > 25%)
- Sydän-ja verisuonitauti
- Tiettyjen lääkkeiden käyttö (esim. statiinit, diureetit, verenpainelääkkeet)
- Nainen
- Tatuointi hoitoalueella (vartalon alueella)
- Diagnoosi porfyria (valon aiheuttama allergia) tai valoherkkä ihottuma
- Lämpö- tai valoherkkyyteen liittyvien lääkkeiden nykyinen käyttö (esim. amiodaroni, klooripromatsiini, doksisykliini, hydroklooritiatsidi, nalidiksiinihappo, naprokseeni, piroksikaami, tetrasykliini, tioridatsiini, vorikonatsoli)
- Tahdistimen käyttö/perussairaus
- Autoimmuunisairaus(t) diagnosoitu
- Albinismi
- Perifeerinen neuropatia
Opintosuunnitelma
Miten tutkimus on suunniteltu?
Suunnittelun yksityiskohdat
- Ensisijainen käyttötarkoitus: Hoito
- Jako: Satunnaistettu
- Inventiomalli: Rinnakkaistehtävä
- Naamiointi: Yksittäinen
Aseet ja interventiot
Osallistujaryhmä / Arm |
Interventio / Hoito |
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Huijausvertailija: Huijaus PBMT
Vale-PBMT:n sisällyttäminen varmistaa, että kaikki osallistuvat hoitotoimenpiteet pysyvät samoina, lukuun ottamatta fotonien emissiota (aktiivinen hoito), jolloin mahdolliset ryhmien väliset erot voidaan ottaa huomioon PBMT:n käytössä.
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Sham PBMT:n tarjoaa koulutettu tutkimusryhmän jäsen.
Vale-PBMT toimitetaan samalla tavalla kuin yllä olevassa PBMT-prosessissa, mutta laite pysyy valmiustilassa (eli hoitotilaa ei oteta käyttöön).
Koska infrapunavalo on näkymätön paljaalla silmällä, ainoa näkyvä ero hoito- ja valmiustilan välillä on muutama pieni keltainen valo (nämä valot ovat päällä hoitotilan aikana).
Muut nimet:
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Active Comparator: 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.
Muut nimet:
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Mitä tutkimuksessa mitataan?
Ensisijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
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Countermovement Jump (CMJ) Initial Baseline: Concentric Impulse
Aikaikkuna: 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.
Aikaikkuna: 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)
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: Collected at the end of week 1 prior to coach-led training.
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Assesses dynamic strength performance, including concentric impulse via force plates and analysis software.
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Collected at the end of week 1 prior to coach-led training.
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Countermovement Jump (CMJ) Week 1 Follow-up: Movement Start to Peak Power
Aikaikkuna: Collected at the end of week 1 prior to coach-led training.
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Assesses dynamic strength performance, including Movement Start to peak Power via force plates and analysis software.
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Collected at the end of week 1 prior to coach-led training.
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Countermovement Jump (CMJ) Week 1 Follow-up: Reactive Strength Index-modified (RSImod)
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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)
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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)
Aikaikkuna: Collected at the end of week 3 prior to coach-led training.
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Assesses dynamic strength performance, including Reactive Strength Index-modified (RSImod) via force plates and analysis software. Reactive Strength Index-modified (RSImod) reflects the efficiency of force production during a countermovement jump. It is calculated as jump height divided by time to take-off. Higher values indicate better explosive performance and lower neuromuscular fatigue, whereas lower values indicate reduced efficiency or increased fatigue. The index ranges from 0 upward with no theoretical maximum; therefore, interpretation should rely on normative ranges or athlete-specific baselines. Reference categories: Lower performers (L): ~0.20-0.30 Moderate performers (M): ~0.30-0.45 Upper performers (U): ~0.45-0.70+ |
Collected at the end of week 3 prior to coach-led training.
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Countermovement Jump (CMJ) Week 3 Follow-up: Time to Take-Off
Aikaikkuna: 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
Aikaikkuna: 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.
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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.
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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)
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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)
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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 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
Aikaikkuna: 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
Aikaikkuna: 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.
|
Toissijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
|
Body Measurements: Body Composition (% Body Fat)
Aikaikkuna: Measured prior to treatment starting at time of enrollment.
|
Biometrics
|
Measured prior to treatment starting at time of enrollment.
|
|
Body Measurements: Height (Inches)
Aikaikkuna: Measured prior to treatment starting at time of enrollment.
|
Biometrics
|
Measured prior to treatment starting at time of enrollment.
|
|
Body Measurements: Weight (Lbs)
Aikaikkuna: 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)
Aikaikkuna: 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)
Aikaikkuna: 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)
Aikaikkuna: Measured prior to treatment starting at time of enrollment.
|
Biometrics - used to calculate PBMT dosage
|
Measured prior to treatment starting at time of enrollment.
|
Muut tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
|
Rungon mitat: Korkeus (cm)
Aikaikkuna: Mitattu ennen hoitoa ilmoittautumishetkellä.
|
Biometriset tiedot
|
Mitattu ennen hoitoa ilmoittautumishetkellä.
|
|
Kehon mitat: Paino (kg/lbs)
Aikaikkuna: Mitattu ennen hoitoa ilmoittautumishetkellä.
|
Biometriset tiedot
|
Mitattu ennen hoitoa ilmoittautumishetkellä.
|
|
Kehon mitat: Kehon koostumus (% kehon rasvaa)
Aikaikkuna: Mitattu ennen hoitoa ilmoittautumishetkellä.
|
Biometriset tiedot
|
Mitattu ennen hoitoa ilmoittautumishetkellä.
|
|
Vartalon mitat: C1 - reiden proksimaalinen ympärysmitta (cm)
Aikaikkuna: Mitattu ennen hoitoa ilmoittautumishetkellä.
|
Biometriset tiedot - käytetään PBMT-annoksen laskemiseen
|
Mitattu ennen hoitoa ilmoittautumishetkellä.
|
|
Vartalon mitat: C2 - distaalinen reiden ympärysmitta (cm)
Aikaikkuna: Mitattu ennen hoitoa ilmoittautumishetkellä.
|
Biometriset tiedot - käytetään PBMT-annoksen laskemiseen
|
Mitattu ennen hoitoa ilmoittautumishetkellä.
|
|
Vartalon mitat: L1 - reiden pituus (cm)
Aikaikkuna: Mitattu ennen hoitoa ilmoittautumishetkellä.
|
Biometriset tiedot - käytetään PBMT-annoksen laskemiseen
|
Mitattu ennen hoitoa ilmoittautumishetkellä.
|
Yhteistyökumppanit ja tutkijat
Yhteistyökumppanit
Tutkijat
- Päätutkija: Tanner Santarelli, DPT, 1st Special Forces Group Tactical Human Optimization, Rapid Rehabilitation and Reconditioning (THOR3)
Julkaisuja ja hyödyllisiä linkkejä
Yleiset julkaisut
- 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.
Hyödyllisiä linkkejä
Opintojen ennätyspäivät
Opi tärkeimmät päivämäärät
Opiskelun aloitus (Todellinen)
Ensisijainen valmistuminen (Todellinen)
Opintojen valmistuminen (Todellinen)
Opintoihin ilmoittautumispäivät
Ensimmäinen lähetetty
Ensimmäinen toimitettu, joka täytti QC-kriteerit
Ensimmäinen Lähetetty (Todellinen)
Tutkimustietojen päivitykset
Viimeisin päivitys julkaistu (Todellinen)
Viimeisin lähetetty päivitys, joka täytti QC-kriteerit
Viimeksi vahvistettu
Lisää tietoa
Tähän tutkimukseen liittyvät termit
Muita asiaankuuluvia MeSH-ehtoja
Muut tutkimustunnusnumerot
- USUHS.2023-126
Yksittäisten osallistujien tietojen suunnitelma (IPD)
Aiotko jakaa yksittäisten osallistujien tietoja (IPD)?
IPD-suunnitelman kuvaus
Tämän tutkimustutkimuksen alkuperäisessä suostumuslomakkeessa (ICF) todetaan, että tunnistamattomat tutkimustiedot jaetaan MIRRORin ja USU:n kanssa ja niitä säilytetään toistaiseksi mahdollista tulevaa tutkimusta varten. Suostumalla osallistumaan tähän tutkimukseen osallistujat antavat meille luvan säilyttää heidän tunnistamattomia tutkimustietojaan toistaiseksi mahdollista tulevaa tutkimusta varten.
Osallistujille ei anneta mahdollisuutta kieltäytyä säilyttämästä heidän tunnistamattomia tutkimustietojaan toistaiseksi mahdollista tulevaa käyttöä varten. ICF toteaa: "Jos et halua, että osana tätä tutkimusta kerättyjä tunnistamattomia tietojasi säilytetään tulevissa tutkimustutkimuksissa, sinun ei tule allekirjoittaa tätä suostumuslomaketta."
IPD-jakamista tukeva tietotyyppi
- STUDY_PROTOCOL
- MAHLA
- ICF
- ANALYTIC_CODE
- CSR
Lääke- ja laitetiedot, tutkimusasiakirjat
Tutkii yhdysvaltalaista FDA sääntelemää lääkevalmistetta
Tutkii yhdysvaltalaista FDA sääntelemää laitetuotetta
Yhdysvalloissa valmistettu ja sieltä viety tuote
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