Effect of Whole-body Photobiomodulation on Muscular Performance Enhancement.

Study Overview
=================
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%.

Official Title
-----------------
Effect of Whole-body Photobiomodulation on Muscular Performance Enhancement.

Conditions
-----------------
Sports Performance, Injury Prevention, Muscle Damage, Musculoskeletal Pain

Intervention / Treatment
-----------------
* Other: Muscle damage protocol training
* Device: Photobiomodulation therapy (PBMT)


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
Male

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PBMT post muscle damage protocol (PBMT-post)<br>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<br>* 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).<br>Device: Photobiomodulation therapy (PBMT)<br>* 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.<br>|
| Experimental: PBMT pre (PBMT-pre)<br>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<br>* 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).<br>Device: Photobiomodulation therapy (PBMT)<br>* 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.<br>|
| Sham Comparator: PBMT placebo (PBMT-sham)<br>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<br>* 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).<br>Device: Photobiomodulation therapy (PBMT)<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 
| 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) | 
| 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) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
phototherapy, laser therapy, muscle fatigue, muscle damage