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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05989815
Other study ID # 62842522.2.0000.5504
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date July 10, 2023
Est. completion date December 20, 2023

Study information

Verified date March 2024
Source Universidade Federal de Sao Carlos
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Introduction: Photobiomodulation therapy (PBMT) is based on the emission of light ranging from red to near-infrared spectra by different devices based on diode lasers or light-emitting diodes. These devices emitting different wavelengths can increase mitochondrial activity and energy synthesis (ATP - adenosine triphosphate) that in turn can help to prevent muscle damage, decrease muscle fatigue and enhance muscle performance. Thus, PBMT can be a promising therapeutic resource in the sports field. Objectives: The aim of this study is to verify the effect of PBMT on the muscle performance and prevention of muscle damage and delayed onset muscle soreness (DOMS) in professional soccer players submitted to a muscle damage protocol. Methodology: The present study is a randomized sham-controlled clinical trial following the SPIRIT guidelines.


Description:

Participants will be allocated into 3 balanced randomized groups, as follows: 1) PBMT post muscle damage protocol (PBMT-post); 2) PBMT pre (PBMT-pre) and 3) PBMT placebo (PBMT-sham). All groups will be submitted to a) anamnesis; b) measurement of blood levels of creatine phosphokinase (CK); c) delayed onset muscle soreness (DOMS); d) muscle performance tests (Squat Jump test (SJ) and Counter Movement Jump (CMJ)); e) dynamometry of the knee extensor muscles. Whole body PBMT will be applied according to the groups, during 10 min (sham or effective), with an effective dose of 13.85 J/cm2 and irradiance of 46.17 mW/cm2. Muscle damage protocol will consist of 8 exercises for lower limb muscles, with 3 sets of 10 repetitions each, 1 minute of rest between sets, and 2 minutes of rest between exercises. Next, participants will be evaluated for levels of CK, DOMS and muscle performance (SJ, CMJ, dynamometry) at 24, 48 and 72 hours after muscle damage protocol. Data will be analyzed and compared between groups with a significance level of 5%.


Recruitment information / eligibility

Status Completed
Enrollment 30
Est. completion date December 20, 2023
Est. primary completion date November 10, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 18 Years and older
Eligibility Inclusion Criteria: - Male individuals aged between 18 and 35 years, professional soccer players who engage in training at least 5 times a week, will be selected. Data collection will be conducted at the Desportivo Brasil Football Club, located in Porto Feliz, São Paulo. The sample will consist of team members, with a total of 36 athletes established to compose the sample. All data collection will take place in the same location. Exclusion Criteria: - Individuals with any impediment to physical activity or those presenting dysfunctions that may impair the neuromuscular system will be excluded.

Study Design


Intervention

Other:
Muscle damage protocol training
The adopted protocol of muscle damage will follow the recommendations from American College of Sports Medicine (ACSM) in 2009 for trained individuals. It consists of 8-12 repetitions above 70% of 1 Repetition Maximum (1RM) with 1 minute of rest between sets and 2 minutes between exercises. The protocol will be composed as follows: 3 sets of 10 repetitions for each exercise, with an emphasis on producing microlesions in the muscle tissue (muscle damage protocol).
Device:
Photobiomodulation therapy (PBMT)
PBMT will be administered using the Joovv Elite System, which has 6 panels of red LEDs (660±10nm) and 74 panels of infrared LEDs (850±10nm), totaling 900 LEDs covering an area of 12,193 cm². Athletes will stand 20 cm in front of the device, wearing only swim shorts to expose their thigh muscles and other body areas to the light. The total irradiation time will be 20 minutes, with 10 minutes (600 seconds) of irradiation for the anterior region and another 10 minutes (600 seconds) for the posterior region. The active PBMT dose applied in each region (anterior or posterior) will be 48.97 J/cm², with an irradiance of 81.62 milliwatt (mW)/cm². The PBMT Sham dose applied in each region (anterior or posterior) will be 0 J/cm², with an irradiance of 0 mW/cm².

Locations

Country Name City State
Brazil Desportivo Brasil Football Club Porto Feliz São Paulo

Sponsors (1)

Lead Sponsor Collaborator
Universidade Federal de Sao Carlos

Country where clinical trial is conducted

Brazil, 

References & Publications (14)

American College of Sports Medicine. American College of Sports Medicine position stand. Progression models in resistance training for healthy adults. Med Sci Sports Exerc. 2009 Mar;41(3):687-708. doi: 10.1249/MSS.0b013e3181915670. — View Citation

Anders JJ, Arany PR, Baxter GD, Lanzafame RJ. Light-Emitting Diode Therapy and Low-Level Light Therapy Are Photobiomodulation Therapy. Photobiomodul Photomed Laser Surg. 2019 Feb;37(2):63-65. doi: 10.1089/photob.2018.4600. Epub 2019 Jan 24. No abstract available. — View Citation

Azuma RHE, Merlo JK, Jacinto JL, Borim JM, da Silva RA, Pacagnelli FL, Nunes JP, Ribeiro AS, Aguiar AF. Photobiomodulation Therapy at 808 nm Does Not Improve Biceps Brachii Performance to Exhaustion and Delayed-Onset Muscle Soreness in Young Adult Women: A Randomized, Controlled, Crossover Trial. Front Physiol. 2021 Jun 10;12:664582. doi: 10.3389/fphys.2021.664582. eCollection 2021. — View Citation

Cressoni MD, Dib Giusti HH, Casarotto RA, Anaruma CA. The effects of a 785-nm AlGaInP laser on the regeneration of rat anterior tibialis muscle after surgically-induced injury. Photomed Laser Surg. 2008 Oct;26(5):461-6. doi: 10.1089/pho.2007.2150. — View Citation

Denadai AS, de Carvalho Pde T, dos Reis FA, Belchior AC, Pereira DM, Dourado DM, Silva IS, de Oliveira LV. Morphometric and histological analysis of low-power laser influence on bone morphogenetic protein in bone defects repair. Lasers Med Sci. 2009 Sep;24(5):689-95. doi: 10.1007/s10103-008-0595-6. Epub 2008 Sep 12. — View Citation

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. — View Citation

Enwemeka CS. Light is light. Photomed Laser Surg. 2005 Apr;23(2):159-60. doi: 10.1089/pho.2005.23.159. No abstract available. — View Citation

Ferreira-Valente MA, Pais-Ribeiro JL, Jensen MP. Psychometric properties of the portuguese version of the Pain Self-Efficacy Questionnaire. Acta Reumatol Port. 2011 Jul-Sep;36(3):260-7. — View Citation

Higashi RH, Toma RL, Tucci HT, Pedroni CR, Ferreira PD, Baldini G, Aveiro MC, Borghi-Silva A, de Oliveira AS, Renno AC. Effects of low-level laser therapy on biceps braquialis muscle fatigue in young women. Photomed Laser Surg. 2013 Dec;31(12):586-94. doi: 10.1089/pho.2012.3388. — View Citation

Julio CE, Antonialli FC, Nascimento TMD, Sa KA, Barton GJ, Lucareli PRG. The Movement Deviation Profile Can Differentiate Faller and Non-Faller Older Adults. J Gerontol A Biol Sci Med Sci. 2023 Aug 27;78(9):1651-1658. doi: 10.1093/gerona/glad141. — View Citation

Lesnak J, Anderson D, Farmer B, Katsavelis D, Grindstaff TL. VALIDITY OF HAND-HELD DYNAMOMETRY IN MEASURING QUADRICEPS STRENGTH AND RATE OF TORQUE DEVELOPMENT. Int J Sports Phys Ther. 2019 Apr;14(2):180-187. — View Citation

Qureshi MA, Mcisaac L, Schlyer D, Hupf HB, Al-Watban FA, Lewall D. Production of 123I as iodide by distillation. Int J Nucl Med Biol. 1985;12(1):57-8. doi: 10.1016/0047-0740(85)90014-2. No abstract available. — View Citation

Thong ISK, Tan G, Lee TYC, Jensen MP. A Comparison of Pain Beliefs and Coping Strategies and Their Association with Chronic Pain Adjustment Between Singapore and United States. Pain Med. 2017 Sep 1;18(9):1668-1678. doi: 10.1093/pm/pnw237. — View Citation

Zagatto AM, Dutra YM, Lira FS, Antunes BM, Faustini JB, Malta ES, Lopes VHF, de Poli RAB, Brisola GMP, Dos Santos GV, Rodrigues FM, Ferraresi C. Full Body Photobiomodulation Therapy to Induce Faster Muscle Recovery in Water Polo Athletes: Preliminary Results. Photobiomodul Photomed Laser Surg. 2020 Dec;38(12):766-772. doi: 10.1089/photob.2020.4803. — View Citation

* Note: There are 14 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Primary Measurement of blood levels of creatine phosphokinase (CK) Measure blood levels of creatine phosphokinase (CK) at baseline and after 24h, 48h, and 72h from the muscle damage protocol." Total of four consecutive days, from the 1st-day baseline to the 4th day (72 hours after the protocol)
Secondary Muscle performance tests by Jump tests This muscle performance tests consists in: Squat Jump test (SJ) and Counter Movement Jump (CMJ), measured by the height of the vertical saint in centimeters (cm). Total of four consecutive days, from the 1st-day baseline to the 4th day (72 hours after the protocol)
Secondary Muscle performance tests - Dynamometry This muscle performance tests consists in: dynamometry of the knee extensor muscles, measured by peak force in kilograms of force (kgf) of the subject's dominant leg. Total of four consecutive days, from the 1st-day baseline to the 4th day (72 hours after the protocol)
Secondary Delayed onset muscle soreness (DOMS) The perception of DOMS (Delayed-Onset Muscle Soreness) will be evaluated using a Numeric Rating Scale (NRS) for pain The scale will be numbered from 0 to 10, with 0 indicating no muscle pain and 10 meaning that the muscles were very sore during a maximal voluntary contraction for knee extension in a sitting position, and the location of DOMS will be assessed through a specific pain map tool. Two variables, namely the extent and location of pain, will be used to estimate the outcomes. Total of four consecutive days, from the 1st-day baseline to the 4th day (72 hours after the protocol)
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