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a-tDCS Combined With Aerobic Exercise in Healthy Individuals

2020年1月22日 更新者:Marmara University

The Effect of Anodal Transcranial Direct Current Stimulation Combined With Aerobic Exercise on Performance in Healthy Individuals

The purpose of this study is to assess the effects on the exercise performance of anodal transcranial direct current stimulation combined with aerobic exercise in healthy individuals.

研究概览

详细说明

Transcranial direct current stimulation (tDCS) is a non-invasive brain stimulation method that has become increasingly popular in recent years. tDCS shows promising improvements for the motor performance of healthy individuals as well as pathological conditions. Moreover, it is frequently preferred because of its safety advantage, high tolerability as well as being cheap, portable and easily applicable.

Studies have shown that tDCS can modulate the excitability of both cortical and subcortical brain regions. In recent years, there have been scientific studies investigating the effects of tDCS on improving physical performance in healthy individuals, but these studies are limited in number, their results are conflicted and as far as the investigators know there is no study that combines tDCS with exercise.

Moreover, although the mechanisms of tDCS on physical performance are largely unknown, some tDCS devices are open to public usage and a large number of professional athletes have reported using tDCS during their training programs. Therefore, studies are needed to demonstrate the effects of tDCS which combined with exercise on performance.

The aim of this study was to investigate the effects of anodal transcranial direct current stimulation combined with aerobic exercise on physical performance in healthy individuals.

研究类型

介入性

注册 (预期的)

21

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

      • İstanbul、火鸡
        • Marmara University

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

20年 至 25年 (成人)

接受健康志愿者

有资格学习的性别

男性

描述

Inclusion Criteria:

  • Healthy subject
  • No use of any ergogenic substance in one year
  • No history of active exercise training in last 6 months

Exclusion Criteria:

  • Pacemaker
  • Intracerebral metallic implant
  • Using dietary supplementation or medication potentially affecting the CNS
  • Musculoskeletal injury within the past 6 weeks
  • Lower extremity pain above 3 or more according to numeric pain scale
  • History of epilepsy or convulsive crisis

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:基础科学
  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:三倍

武器和干预

参与者组/臂
干预/治疗
实验性的:Real tDCS and Exercise
tDCS (tDCS - TCT Research Limited, Hong Kong) / Exercise Group in which will receive the active intervention of aerobic exercise training and active tDCS intervention at the same time.
Real tDCS (TCT Research Limited, Hong Kong); 3 times a week on alternate days for consecutive 6 weeks. The active session of tDCS will consist in applying anodal stimulation over left M1 (C3 according to the 10-20 international EEG placement) and the cathodal stimulation over right supraorbital area (Fp2 according to the 10-20 international EEG placement), and to inject 2 mA for 20 minutes through sponge electrodes (35 cm²) placed on the scalp.
The Exercise intervention will include only aerobic exercise 3 times a week on alternate days for consecutive 6 weeks. The program will last 20 minutes.
假比较器:Sham tDCS and Exercise
Sham tDCS (tDCS - TCT Research Limited, Hong Kong) / Exercise Group in which will receive the active intervention of aerobic exercise training and sham tDCS intervention at the same time.
The Exercise intervention will include only aerobic exercise 3 times a week on alternate days for consecutive 6 weeks. The program will last 20 minutes.
Sham current (TCT Research Limited, Hong Kong); 3 times a week on alternate days for consecutive 6 weeks. The sham tDCS will use the same montage and device but direct current will only be injected for 30 seconds, with a ramp-up and ramp-down 15 seconds period, to mimic the somatosensory effects of active tDCS.
其他:Exercise
Exercise group in which will receive the active intervention of aerobic exercise training no tDCS intervention.
The Exercise intervention will include only aerobic exercise 3 times a week on alternate days for consecutive 6 weeks. The program will last 20 minutes.

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Effect of tDCS combined with aerobic exercise on exercise performance in healthy individuals.
大体时间:2 months
The performance will be evaluated by measuring the maximal consumption of oxygen (VO2max). VO2max will be assessed continuously during the time to exhaustion trial using a gas analyzer
2 months
Effect of tDCS combined with aerobic exercise on ratings of perceived exertion (RPE) in healthy individuals.
大体时间:2 months
RPE will be assessed continuously (every 3 minutes) during the time to exhaustion trial using the Borg rating of perceived exertion scale (RPE scale). The Borg RPE scale is a quantitative measure of perceived exertion during physical activity. The scale starts with "no feeling of exertion," which rates a 6, and ends with "very, very hard," which rates a 20. Moderate activities register 11 to 14 on the Borg scale ("fairly light" to "somewhat hard"), while vigorous activities usually rate a 15 or higher ("hard" to "very, very hard").
2 months

次要结果测量

结果测量
措施说明
大体时间
Effect of tDCS combined with aerobic exercise on isokinetic muscle strength in healthy individuals.
大体时间:2 months
The isokinetic muscle strength of knee extensors of the dominant leg will be evaluated by using Biodex System 3 isokinetic dynamometer (Biodex Medical Systems, Shirley, NY, USA)
2 months

其他结果措施

结果测量
措施说明
大体时间
Changes in SF-36 questionnaire of quality of life
大体时间:2 months
This questionnaire evaluates different aspects of individual life such as Vitality, physical functioning, bodily pain, general health perceptions, physical role functioning, emotional role functioning, social role functioning, and mental health. Through different questions, a score is generated for each subscale where zero represents the worst quality of life and 100 the best quality of life.
2 months
Changes in Cognitive Test Battery
大体时间:2 months
An n-back cognitive test will be conducted for assessing the working memory.
2 months

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 研究主任:Mine Gulden Polat, PhD、Marmara University
  • 学习椅:Lutfu Hanoglu, PhD、Medipol University

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (预期的)

2020年3月1日

初级完成 (预期的)

2021年10月29日

研究完成 (预期的)

2021年12月29日

研究注册日期

首次提交

2019年12月19日

首先提交符合 QC 标准的

2019年12月23日

首次发布 (实际的)

2019年12月26日

研究记录更新

最后更新发布 (实际的)

2020年1月27日

上次提交的符合 QC 标准的更新

2020年1月22日

最后验证

2019年12月1日

更多信息

与本研究相关的术语

其他研究编号

  • 09.2019.669

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

药物和器械信息、研究文件

研究美国 FDA 监管的药品

研究美国 FDA 监管的设备产品

在美国制造并从美国出口的产品

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

Real tDCS的临床试验

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