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临床试验/NCT03879226
NCT03879226已完成不适用

Effects of Photobiomodulation Therapy in Aerobic Training and Detraining in Humans

University of Nove de Julho2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2019年3月25日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
60
试验地点
2
主要终点
Time until exhaustion.

研究概览

简要总结

In last years it has been demonstrated that photobiomodulation therapy (PBMT) has ergogenic effects. However some key aspects, such as the potentially beneficial effects of PBMT during the detraining period still remain unknown.

Therefore, the aim of this project is to evaluate the effects of PBMT applied before and after aerobic training sessions and during the detraining period.

详细描述

It will be carried out a randomized, triple-blind, placebo-controlled trial.

Seventy-two volunteers will be randomly allocated to four experimental groups:

  1. PBMT before and after the aerobic training sessions and PBMT during the detraining period;
  2. PBMT before and after the aerobic training sessions and placebo during the detraining period;
  3. Placebo before and after the aerobic training sessions and PBMT during the detraining period;
  4. Placebo before and after the aerobic training sessions and placebo during the detraining period .

The individuals randomly allocated to the different groups will be subjected to 12 consecutive weeks of aerobic training performed on a treadmill 3 times a week on non-consecutive days. Each training session will last 30 minutes, with an intensity ranging from 85 to 90% maximum heart rate. PBMT or placebo will be applied before and after each training session. After the 12-week training period, the volunteers will receive the application of PBMT or placebo depending on the group to which they are allocated for 4 weeks (3 times a week) without training.

The data will be collected by a blind assessor. It will be analyzed time of the exercise (time until exhaustion), maximum oxygen consumption in absolute and relative values in relation to body mass (VO2max). Moreover, it will be evaluated the body composition. The evaluations will be performed before starting the protocol (baseline) and after 4, 8, and 12 weeks of training. They will also be performed after 4 weeks without training (detraining period).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

盲法说明

A researcher will program the device (placebo or PMBT) and will be instructed not to inform the volunteers or other researchers as to the type of treatment (PMBT or placebo). Therefore, the researcher responsible for the treatment will be blinded to the type of treatment being administered to the volunteers. The sounds and signals emitted from the device as well as the information displayed on the screen will be identical, regardless of the type of treatment (placebo or PBMT).

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

  • Healthy men;
  • Aged from 18 to 35 years;
  • Complete at least 80% of the study procedures will be included in the study.

排除标准

  • History of musculoskeletal injury in the hip and knee regions in the 2 months before the study;
  • Become injured during the study;
  • Regularly use pharmacological agents and/ or nutritional supplements;
  • Signs and symptoms of any neurological, metabolic, inflammatory, pulmonary, oncological, or cardiovascular disease that may limit the execution of high-intensity exercises.

结局指标

主要结局

Time until exhaustion.

时间窗: 16 weeks - 4 weeks after completing the training (detraining period).

The time until exhaustion will be measured by the software of ergospirometry system.

次要结局

  • Time until exhaustion.(4, 8, and 12 weeks after starting the training period.)
  • Maximum oxygen consumption (VO2).(4, 8, and 12 weeks after starting the training period, and at 4 weeks after completing the training (detraining period).)
  • Fat percentage.(4, 8, and 12 weeks after starting the training period, and at 4 weeks after completing the training (detraining period).)

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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