Back to results

Effect of Whole-body Photobiomodulation on Muscular Performance Enhancement. (WBPME)

Primary Purpose

Sports Performance, Injury Prevention, Muscle Damage

Status

Recruiting

Phase

Not Applicable

Locations

Brazil

Study Type

Interventional

Intervention

Muscle damage protocol training

Photobiomodulation therapy (PBMT)

About this trial

This is an interventional treatment trial for Sports Performance focused on measuring phototherapy, laser therapy, muscle fatigue, muscle damage

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleAccepts Healthy Volunteers

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.

Sites / Locations

Desportivo Brasil Football ClubRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Sham Comparator

Arm Label

PBMT post muscle damage protocol (PBMT-post)

PBMT pre (PBMT-pre)

PBMT placebo (PBMT-sham)

Arm Description

Group submitted to pre-exercise Sham (placebo) photobiomodulation therapy (PBMT), and post-exercise active PBMT. PBMT will be administered using the Joovv Elite System, which has 6 panels of red Light-Emiting Diodes (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 mW/cm².

Group submitted to pre-exercise active photobiomodulation therapy (PBMT), and post-exercise Sham (placebo) PBMT. PBMT will be administered using the Joovv Elite System, which has 6 panels of red Light-Emiting Diodes (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 mW/cm².

Group submitted to pre-exercise and post-exercise photobiomodulation therapy (PBMT) Sham (placebo). PBMT will be administered using the Joovv Elite System, which has 6 panels of red Light-Emiting Diodes(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 Sham PBMT dose applied in each region (anterior or posterior) will be 0 J/cm², with an irradiance of 0 mW/cm².

Outcomes

Primary Outcome Measures

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."

Secondary Outcome Measures

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).

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.

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.

Full Information

NCT ID

NCT05989815

First Posted

August 1, 2023

Last Updated

August 9, 2023

Sponsor

Universidade Federal de Sao Carlos

1. Study Identification

Unique Protocol Identification Number

NCT05989815

Brief Title

Effect of Whole-body Photobiomodulation on Muscular Performance Enhancement.

Acronym

WBPME

Official Title

Effect of Whole-body Photobiomodulation on Muscular Performance Enhancement.

Study Type

Interventional

2. Study Status

Record Verification Date

August 2023

Overall Recruitment Status

Recruiting

Study Start Date

July 10, 2023 (Actual)

Primary Completion Date

November 10, 2023 (Anticipated)

Study Completion Date

December 20, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Universidade Federal de Sao Carlos

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Product Manufactured in and Exported from the U.S.

Yes

Data Monitoring Committee

5. Study Description

Brief 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.

Detailed 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%.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Sports Performance, Injury Prevention, Muscle Damage, Musculoskeletal Pain

Keywords

phototherapy, laser therapy, muscle fatigue, muscle damage

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

36 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

PBMT post muscle damage protocol (PBMT-post)

Arm Type

Experimental

Arm Description

Arm Title

PBMT pre (PBMT-pre)

Arm Type

Experimental

Arm Description

Arm Title

PBMT placebo (PBMT-sham)

Arm Type

Sham Comparator

Arm Description

Intervention Type

Other

Intervention Name(s)

Muscle damage protocol training

Intervention Description

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).

Intervention Type

Device

Intervention Name(s)

Photobiomodulation therapy (PBMT)

Intervention Description

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.

Primary Outcome Measure Information:

Title

Measurement of blood levels of creatine phosphokinase (CK)

Description

Measure blood levels of creatine phosphokinase (CK) at baseline and after 24h, 48h, and 72h from the muscle damage protocol."

Time Frame

Total of four consecutive days, from the 1st-day baseline to the 4th day (72 hours after the protocol)

Secondary Outcome Measure Information:

Title

Muscle performance tests by Jump tests

Description

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).

Time Frame

Total of four consecutive days, from the 1st-day baseline to the 4th day (72 hours after the protocol)

Title

Muscle performance tests - Dynamometry

Description

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.

Time Frame

Total of four consecutive days, from the 1st-day baseline to the 4th day (72 hours after the protocol)

Title

Delayed onset muscle soreness (DOMS)

Description

Time Frame

Total of four consecutive days, from the 1st-day baseline to the 4th day (72 hours after the protocol)

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Italo A de Oliveira, Bachelor

Phone

+55 19 997190361

italoao@estudante.ufscar.br

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Cleber Ferraresi, Phd

Organizational Affiliation

Universidade Federal de Sao Carlos

Official's Role

Study Director

Facility Information:

Facility Name

Desportivo Brasil Football Club

City

Porto Feliz

State/Province

São Paulo

ZIP/Postal Code

18546-412

Country

Brazil

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Italo A Oliveira, Bachelor

Phone

+55 19 997190361

italoao@estudante.ufscar.br

First Name & Middle Initial & Last Name & Degree

Italo A de Oliveira, Bachelor

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

33332232

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.

Results Reference

background

PubMed Identifier

27694147

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.

Results Reference

background

PubMed Identifier

30997270

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.

Results Reference

background

PubMed Identifier

24320801

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.

Results Reference

background

PubMed Identifier

22113601

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.

Results Reference

background

PubMed Identifier

15910178

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.

Results Reference

background

PubMed Identifier

18787760

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.

Results Reference

background

PubMed Identifier

30607719

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.

Results Reference

background

PubMed Identifier

18800950

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.

Results Reference

background

PubMed Identifier

34177615

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.

Results Reference

background

PubMed Identifier

37279546

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.

Results Reference

background

PubMed Identifier

31050924

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.

Results Reference

background

PubMed Identifier

4008167

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.

Results Reference

background

PubMed Identifier

19204579

Citation

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.

Results Reference

background

Learn more about this trial

Effect of Whole-body Photobiomodulation on Muscular Performance Enhancement.

We'll reach out to this number within 24 hrs