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

Sponsor
Universidade Federal de Sao Carlos (Other)
Overall Status
Recruiting
CT.gov ID
NCT05989815
Collaborator
(none)
36
Enrollment
1
Location
3
Arms
5.4
Anticipated Duration (Months)
6.7
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Muscle damage protocol training
  • Device: Photobiomodulation therapy (PBMT)
 N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
36 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Effect of Whole-body Photobiomodulation on Muscular Performance Enhancement.
Actual Study Start Date :
Jul 10, 2023
Anticipated Primary Completion Date :
Nov 10, 2023
Anticipated Study Completion Date :
Dec 20, 2023

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Measurement of blood levels of creatine phosphokinase (CK) [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."

Secondary Outcome Measures

  1. Muscle performance tests by Jump tests [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).

  2. Muscle performance tests - Dynamometry [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.

  3. Delayed onset muscle soreness (DOMS) [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
Male
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Desportivo Brasil Football Club Porto Feliz São Paulo Brazil 18546-412

Sponsors and Collaborators

  • Universidade Federal de Sao Carlos

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Italo Amaral de Oliveira, Principal Investigator, Universidade Federal de Sao Carlos
ClinicalTrials.gov Identifier:
NCT05989815
Other Study ID Numbers:
  • 62842522.2.0000.5504
First Posted:
Aug 14, 2023
Last Update Posted:
Aug 14, 2023
Last Verified:
Aug 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
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
Keywords provided by Italo Amaral de Oliveira, Principal Investigator, Universidade Federal de Sao Carlos
phototherapy
laser therapy
muscle fatigue
muscle damage
Additional relevant MeSH terms:
Musculoskeletal Pain

Study Results

No Results Posted as of Aug 14, 2023