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临床试验/NCT03803956
NCT03803956已完成不适用

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

University of Nove de Julho2 个研究点 分布在 1 个国家目标入组 22 人开始时间: 2019年1月16日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
22
试验地点
2
主要终点
Rates of oxygen uptake (VO2max).

研究概览

简要总结

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.

详细描述

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).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Prevention
盲法
Triple (Participant, Investigator, Outcomes Assessor)

盲法说明

The mode of intervention (active or placebo photobiomodulation) will be coded by an independent researcher. The randomization schedule will contain only codes (not the actual intervention). The output from the laser device is exactly the same from either the active or the placebo interventions. These features will guarantee that participants, therapists and outcomes assessor will be blinded to the treatment arms.

入排标准

年龄范围
18 Years 至 35 Years(Adult)
性别
Male
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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.

研究组 & 干预措施

Active PBMT

Active Comparator

Application of PBMT (Photobiomodulation Therapy) with a total dose of 850 Joules.

干预措施: Active PBMT (Device)

Placebo PBMT

Placebo Comparator

Application of placebo PBMT (Photobiomodulation Therapy) without any dose (0 Joule).

干预措施: Placebo PBMT (Device)

结局指标

主要结局

Rates of oxygen uptake (VO2max).

时间窗: Immediately after (1 minute) of ergospirometry test. Observation: the rates of oxygen uptake (relative and absolute) will be measured during the progressive running test.

The rates of oxygen uptake will be measured by an ergospirometry test.

次要结局

  • Activity of creatine kinase - CK.(The blood samples will be collected 5 minutes after the ergospirometry test (progressive running test).)
  • Levels of interleukin 1 beta - IL-1b.(The blood samples will be collected 5 minutes after the ergospirometry test (progressive running test).)
  • Levels of carbonylated proteins.(The blood samples will be collected 5 minutes after the ergospirometry test (progressive running test).)
  • Activity of catalase - CAT.(The blood samples will be collected 5 minutes after the ergospirometry test (progressive running test).)
  • Levels of Thiobarbituric acid - TBARS(The blood samples will be collected 5 minutes after the ergospirometry test (progressive running test).)
  • Aerobic threshold.(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.)
  • Activity of lactate dehydrogenase - LDH.(The blood samples will be collected 5 minutes after the ergospirometry test (progressive running test).)
  • Time until exhaustion.(Immediately after (1 minute) of ergospirometry test (progressive running test). Observation: the time until exhaustion will be measured during the progressive running test.)
  • Anaerobic threshold.(Immediately after (1 minute) of ergospirometry test (progressive running test). Observation: the aerobic threshold will be measured during the progressive running test.)
  • Levels of interleukin 6 - IL-6.(The blood samples will be collected 5 minutes after the ergospirometry test (progressive running test).)
  • Levels of tumor necrosis factor alpha - TNF-a.(The blood samples will be collected 5 minutes after the ergospirometry test (progressive running test).)
  • Activity of superoxidedismutase - SOD.(The blood samples will be collected 5 minutes after the ergospirometry test (progressive running test).)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ernesto Cesar Pinto Leal Junior

Full professor

University of Nove de Julho

研究点 (2)

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