Clinical trial NCT03803956: Infrared Low-level Laser Therapy Before Intense Progressive Running Test of High-level Soccer Players
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Muscle; Fatigue, Heart
Skeletal Muscle Recovery
Keywords: Photobiomodulation therapy
Low-level laser therapy
Performance
Skeletal muscle recovery
High-level soccer players
Intense progressive running test
Lead sponsor: University of Nove de Julho
Sponsor class: OTHER
Collaborators: name: Fundação de Amparo à Pesquisa do Estado de São Paulo
First posted: 2019-01-15
Enrollment: 22
Sex: MALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: The volunteers who will receive active PBMT in the first stage of the study, will receive placebo PBMT in the second stage, while the volunteers that will receive placebo PBMT in the first stage, will receive active PBMT in the second stage of the study.
Primary purpose: PREVENTION

Brief summary: 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.

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).

Eligibility criteria: 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.

Primary outcomes:
measure: Rates of oxygen uptake (VO2max).
timeFrame: 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 outcomes:
measure: Aerobic threshold.
timeFrame: 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.
measure: Anaerobic threshold.
timeFrame: Immediately after (1 minute) of ergospirometry test (progressive running test). Observation: the aerobic threshold will be measured during the progressive running test.
measure: Activity of creatine kinase - CK.
timeFrame: The blood samples will be collected 5 minutes after the ergospirometry test (progressive running test).
measure: Activity of lactate dehydrogenase - LDH.
timeFrame: The blood samples will be collected 5 minutes after the ergospirometry test (progressive running test).
measure: Levels of interleukin 1 beta - IL-1b.
timeFrame: The blood samples will be collected 5 minutes after the ergospirometry test (progressive running test).
measure: Levels of interleukin 6 - IL-6.
timeFrame: The blood samples will be collected 5 minutes after the ergospirometry test (progressive running test).
measure: Levels of tumor necrosis factor alpha - TNF-a.
timeFrame: The blood samples will be collected 5 minutes after the ergospirometry test (progressive running test).
measure: Levels of Thiobarbituric acid - TBARS
timeFrame: The blood samples will be collected 5 minutes after the ergospirometry test (progressive running test).
measure: Levels of carbonylated proteins.
timeFrame: The blood samples will be collected 5 minutes after the ergospirometry test (progressive running test).
measure: Activity of catalase - CAT.
timeFrame: The blood samples will be collected 5 minutes after the ergospirometry test (progressive running test).
measure: Activity of superoxidedismutase - SOD.
timeFrame: The blood samples will be collected 5 minutes after the ergospirometry test (progressive running test).
measure: Time until exhaustion.
timeFrame: Immediately after (1 minute) of ergospirometry test (progressive running test). Observation: the time until exhaustion will be measured during the progressive running test.
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Laboratory of Phototherapy and Innovative Technologies in Health
Study officials:
affiliation: University of Nove de Julho
name: Ernesto Cesar Leal Junior, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.