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临床试验/NCT03416998
NCT03416998已完成不适用

Effect Of Pre-Game Photobiomodulation On Muscle Recovery In Professional Soccer Players: Randomized, Cross-Over, Sham-Controlled, Triple-Blind, Clinical Trial

University of Nove de Julho1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2016年3月3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
30
试验地点
1
主要终点
Muscle recovery

研究概览

简要总结

Background: Photobiomodulation with low-level laser therapy (LLLT) has been widely used in clinical practice for diverse purposes, such as modulation of the inflammatory process, acceleration of the tissue repair process, pain relief and the enhancement of post-exercise recovery. Studies have demonstrated a beneficial interaction between photobiomodulation and the production of creatine kinase, with a reduction in the release of this marker of muscle damage when laser and/or LEDs is administered prior to high-intensity physical activity. The aim of the proposed study is to determine the influence of pre-exercise phototherapy on post-exercise muscle recovery.

Methods: A randomized, cross-over, sham-controlled, double-blind, clinical trial is proposed. The participants will be healthy professional soccer players aged 15 to 20 years from the same team with a body mass index within the ideal range (20 to 25 kg/m2) and no history of lower limb musculoskeletal injuries or surgery or back surgery in the previous six months. The athletes will be allocated to two groups based on the previously calculated sample size and will be blinded to allocation. Creatine kinase will be measured and the subjective perception of fatigue will be determined for each participant. The volunteers will then be randomly allocated to Group A, which will receive active phototherapy, and Group B, which will receive sham phototherapy. The athletes will undergo reevaluations immediately after as well as 48 hours after a football match. The data will be submitted to statistical analysis and the level of significance will be set to 5%.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
Triple (Participant, Care Provider, Investigator)

入排标准

年龄范围
15 Years 至 20 Years(Child, Adult)
性别
Male
接受健康志愿者
是

入选标准

  • •Healthy professional soccer players aged 15 to 20 years from the same team with a body mass index in the ideal range (20 to 25 kg/m2) will be included in the study.

排除标准

  • •A history of musculoskeletal injuries and/or surgeries in the lower limbs or back surgery in the previous six months

研究组 & 干预措施

Phototherapy Active

Active Comparator

Phototherapy active group will be administered 30 minutes prior to the soccer match as well as 48 h after the match in direct contact with the skin with light pressure at predetermined sites: nine on the knee extensor muscles, six on the knee flexor muscles and two on the gastrocnemius muscle on both lower limbs.

干预措施: phototherapy (Other)

Placebo Phototherapy

Placebo Comparator

Phototherapy placebo group will be administered 30 minutes prior to the soccer match as well as 48 h after the match in direct contact with the skin with light pressure at predetermined sites: nine on the knee extensor muscles, six on the knee flexor muscles and two on the gastrocnemius muscle on both lower limbs.

For placebo treatment, the same procedures and treatment times will be employed, but the equipment will be set in placebo mode. Only the researcher in charge of programming the device will have knowledge regarding which treatment is being used. However, the programmer will not participate in the execution of the treatment, evaluations or data analysis

干预措施: phototherapy (Other)

结局指标

主要结局

Muscle recovery

时间窗: 30 Minutes

Analysis of creatine kinase

次要结局

  • Subjective muscle recovery(30 Minutes)

研究者

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

Daniela Ap. Biasotto-Gonzalez

Doctor

University of Nove de Julho

研究点 (1)

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