a-tDCS Combined With Aerobic Exercise in Healthy Individuals
The Effect of Anodal Transcranial Direct Current Stimulation Combined With Aerobic Exercise on Performance in Healthy Individuals
調査の概要
詳細な説明
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.
研究の種類
入学 (予想される)
段階
- 適用できない
連絡先と場所
研究場所
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İstanbul、七面鳥
- Marmara University
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：基礎科学
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：トリプル
武器と介入
参加者グループ / アーム |
介入・治療 |
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実験的：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.
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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.
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偽コンパレータ：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.
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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.
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他の：Exercise
Exercise group in which will receive the active intervention of aerobic exercise training no tDCS intervention.
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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.
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Effect of tDCS combined with aerobic exercise on exercise performance in healthy individuals.
時間枠：2 months
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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
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2 months
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Effect of tDCS combined with aerobic exercise on ratings of perceived exertion (RPE) in healthy individuals.
時間枠：2 months
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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").
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2 months
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Effect of tDCS combined with aerobic exercise on isokinetic muscle strength in healthy individuals.
時間枠：2 months
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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)
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2 months
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その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Changes in SF-36 questionnaire of quality of life
時間枠：2 months
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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.
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2 months
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Changes in Cognitive Test Battery
時間枠：2 months
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An n-back cognitive test will be conducted for assessing the working memory.
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2 months
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協力者と研究者
スポンサー
捜査官
- スタディディレクター：Mine Gulden Polat, PhD、Marmara University
- スタディチェア：Lutfu Hanoglu, PhD、Medipol University
研究記録日
主要日程の研究
研究開始 (予想される)
一次修了 (予想される)
研究の完了 (予想される)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。
Real tDCSの臨床試験
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The Hong Kong Polytechnic UniversityThe University of Hong Kong; University of Magdeburg; University of Waterloo募集
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National University Hospital, SingaporeNational University Health System, Singapore; Agency for Science, Technology and Research完了
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Arizona State UniversityUniversidad Autonoma de Nuevo Leon; Instituto Nacional Psiquiatrico de México - Ciudad de México と他の協力者完了