Infrared Low-level Laser Therapy Before Intense Progressive Running Test of High-level Soccer Players

Infrared Low-level Laser Therapy (Photobiomodulation Therapy) Before Intense Progressive Running Test of High-level Soccer Players: Effects on Functional, Muscle Damage, Inflammatory and Oxidative Stress Markers

Photobiomodulation therapy (PBMT) has recently been used to alleviate postexercise muscle fatigue and enhance muscle recovery, demonstrating positive results. A previous study by the investigator's research group demonstrated the optimal dose and the optimal output power (100 mW) for an infrared wavelength (810 nm). However, the effects of optimized PBMT on performance and post-exercise recovery in high-level soccer players, to date have not been evaluated.

The present research project aims to evaluate the effects of PBMT (using low-level laser therapy) applied before a progressive running test on functional, muscle damage, inflammatory and oxidative stress markers in high-level soccer players.

Study Overview

• Status: Completed
• Conditions: Muscle; Fatigue, Heart; Skeletal Muscle Recovery
• Intervention / Treatment: Device: Active PBMT; Device: Placebo PBMT

Detailed Description

To achieve the proposed objective it will perform a randomized, crossover triple-blinded, placebo-controlled trial, with high-level soccer players as volunteers.

Twenty-two volunteers will be randomly allocated to two intervention groups: active or placebo PBMT before a progressive running test (ergospirometry test).

The blood samples for biochemical analysis will be obtained before and after a progressive running test, and another outcomes (functional) will be obtained during the test.

The data will be collected by a blind assessor. The statistical analysis will follow the intention-to-treat principles and data on functional analysis will be analyzed using the paired and two-tailed t-student test. Data on biochemical analysis will be analyzed using two-way ANOVA, followed by Bonferroni post hoc test.

The investigators will analyze: functional aspects (rates of oxygen uptake -VO2max (absolute and relative), aerobic and anaerobic threshold and time until exhaustion), muscle damage (creatine-kinase -CK and lactate dehydrogenase -LDH), inflammatory markers (IL-1β, IL-6 and TNF-α) and oxidative stress markers (Thiobarbituric acid -TBARS, catalase - CAT, superoxidedismutase - SOD and carbonylated proteins).

• Study Type: Interventional
• Enrollment (Actual): 22
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • São Paulo, Brazil, 01504-001
    • Laboratory of Phototherapy and Innovative Technologies in Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 35 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

Inclusion Criteria:

• High-level soccer players;
• Age between 18 and 35 years;
• Male gender;
• Minimum of 80% participation in team practice sessions;
• Agreement to participate through signed statement of informed consent.

Exclusion Criteria:

• History of musculoskeletal injury to hips or knees in previous 2 months;
• Use of pharmacological agents or nutritional supplements;
• Smokers and alcoholics;
• Occurrence of musculoskeletal injury during the trial;
• Any change in practice routine in relation to rest of the team during the trial.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Active PBMT; Application of PBMT (Photobiomodulation Therapy) with a total dose of 850 Joules.	Device: Active PBMT; The PBMT will be performed using the dose of 10J per diode, previously determined by a previous study and power output of 100 mW per diode, also previously determined. PBMT will be performed at nine different sites of the knee extensor muscles, six different sites of the knee flexor muscles and two different sites of the plantar flex muscles. As the cluster will be 5 diodes and 17 different sites will be irradiated, a total of 85 points will be irradiated in each lower limb, a total of 850 J of energy. The active PBMT will be performed before a progressive running test.
Placebo Comparator: Placebo PBMT; Application of placebo PBMT (Photobiomodulation Therapy) without any dose (0 Joule).	Device: Placebo PBMT; The placebo PBMT will per performed using the dose of 0 J per diode. Placebo PBMT will be performed at nine different sites of the knee extensor muscles, six different sites of the knee flexor muscles and two different sites of the plantar flex muscles. As the cluster will be 5 diodes and 17 different sites will be irradiated, a total of 85 points will be irradiated in each lower limb, a total of 0 J of energy. To ensure blinding, the device emitted the same sound regardless of the programmed mode (active or placebo PBMT). The placebo PBMT will be performed before a progressive running test.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rates of oxygen uptake (VO2max).	The rates of oxygen uptake will be measured by an ergospirometry test.	Immediately after (1 minute) of ergospirometry test. Observation: the rates of oxygen uptake (relative and absolute) will be measured during the progressive running test.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Aerobic threshold.	The aerobic threshold will be measured by an ergospirometry test.	Immediately after (1 minute) of ergospirometry test. Observation: the aerobic threshold will be measured during the progressive runThe aerobic and anaerobic threshold will be measured during the progressive running test.
Anaerobic threshold.	The anaerobic threshold will be measured by an ergospirometry test.	Immediately after (1 minute) of ergospirometry test (progressive running test). Observation: the aerobic threshold will be measured during the progressive running test.
Activity of creatine kinase - CK.	Muscle damage will be measured by blood samples.	The blood samples will be collected 5 minutes after the ergospirometry test (progressive running test).
Activity of lactate dehydrogenase - LDH.	Muscle damage will be measured by blood samples.	The blood samples will be collected 5 minutes after the ergospirometry test (progressive running test).
Levels of interleukin 1 beta - IL-1b.	Inflammation will be measured by blood samples.	The blood samples will be collected 5 minutes after the ergospirometry test (progressive running test).
Levels of interleukin 6 - IL-6.	Inflammation will be measured by blood samples.	The blood samples will be collected 5 minutes after the ergospirometry test (progressive running test).
Levels of tumor necrosis factor alpha - TNF-a.	Inflammation will be measured by blood samples.	The blood samples will be collected 5 minutes after the ergospirometry test (progressive running test).
Levels of Thiobarbituric acid - TBARS	Oxidative stress will be measured by blood samples.	The blood samples will be collected 5 minutes after the ergospirometry test (progressive running test).
Levels of carbonylated proteins.	Oxidative stress will be measured by blood samples.	The blood samples will be collected 5 minutes after the ergospirometry test (progressive running test).
Activity of catalase - CAT.	Oxidative stress will be measured by blood samples.	The blood samples will be collected 5 minutes after the ergospirometry test (progressive running test).
Activity of superoxidedismutase - SOD.	Oxidative stress will be measured by blood samples.	The blood samples will be collected 5 minutes after the ergospirometry test (progressive running test).
Time until exhaustion.	The time until exhaustion will be measured by the software of ergospirometry system.	Immediately after (1 minute) of ergospirometry test (progressive running test). Observation: the time until exhaustion will be measured during the progressive running test.

Collaborators and Investigators

• Sponsor: University of Nove de Julho
• Collaborators: Fundação de Amparo à Pesquisa do Estado de São Paulo
• Investigators: Principal Investigator: Ernesto Cesar Leal Junior, PhD, University of Nove de Julho

Publications and helpful links

General Publications

• Tomazoni SS, Machado CDSM, De Marchi T, Casalechi HL, Bjordal JM, de Carvalho PTC, Leal-Junior ECP. Infrared Low-Level Laser Therapy (Photobiomodulation Therapy) before Intense Progressive Running Test of High-Level Soccer Players: Effects on Functional, Muscle Damage, Inflammatory, and Oxidative Stress Markers-A Randomized Controlled Trial. Oxid Med Cell Longev. 2019 Nov 16;2019:6239058. doi: 10.1155/2019/6239058. eCollection 2019.

Study record dates

Study Major Dates

• Study Start (Actual): January 16, 2019
• Primary Completion (Actual): February 16, 2019
• Study Completion (Actual): February 16, 2019

Study Registration Dates

• First Submitted: January 9, 2019
• First Submitted That Met QC Criteria: January 14, 2019
• First Posted (Actual): January 15, 2019

Study Record Updates

• Last Update Posted (Actual): July 18, 2019
• Last Update Submitted That Met QC Criteria: July 16, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Keywords: Performance; Low-level laser therapy; Photobiomodulation therapy; Skeletal muscle recovery; High-level soccer players; Intense progressive running test
• Additional Relevant MeSH Terms: Fatigue
• Other Study ID Numbers: 397774/2011

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: No