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

March 27, 2024 updated by: Italo Amaral de Oliveira, Universidade Federal de Sao Carlos
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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%.

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • São Paulo
      • Porto Feliz, São Paulo, Brazil, 18546-412
        • Desportivo Brasil Football Club

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: PBMT post muscle damage protocol (PBMT-post)

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.
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.
Experimental: PBMT pre (PBMT-pre)

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.
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.
Sham Comparator: PBMT placebo (PBMT-sham)

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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Measurement of blood levels of creatine phosphokinase (CK)
Time Frame: Total of four consecutive days, from the 1st-day baseline to the 4th day (72 hours after the protocol)
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Muscle performance tests by Jump tests
Time Frame: Total of four consecutive days, from the 1st-day baseline to the 4th day (72 hours after the protocol)
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)
Muscle performance tests - Dynamometry
Time Frame: Total of four consecutive days, from the 1st-day baseline to the 4th day (72 hours after the protocol)
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)
Delayed onset muscle soreness (DOMS)
Time Frame: Total of four consecutive days, from the 1st-day baseline to the 4th day (72 hours after the protocol)
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)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universidade Federal de Sao Carlos

Investigators

  • Study Director: Cleber Ferraresi, Phd, Universidade Federal de Sao Carlos

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 10, 2023

Primary Completion (Actual)

November 10, 2023

Study Completion (Actual)

December 20, 2023

Study Registration Dates

First Submitted

August 1, 2023

First Submitted That Met QC Criteria

August 9, 2023

First Posted (Actual)

August 14, 2023

Study Record Updates

Last Update Posted (Actual)

March 29, 2024

Last Update Submitted That Met QC Criteria

March 27, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 62842522.2.0000.5504

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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