a-tDCS Combined With Aerobic Exercise in Healthy Individuals
22 janvier 2020 mis à jour par: 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.
Aperçu de l'étude
Statut
Inconnue
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Interventionnel
Inscription (Anticipé)
21
Phase
- N'est pas applicable
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
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İstanbul, Turquie
- Marmara University
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Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
20 ans à 25 ans (Adulte)
Accepte les volontaires sains
Non
Sexes éligibles pour l'étude
Homme
La description
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
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Science basique
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Tripler
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
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Expérimental: 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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Comparateur factice: 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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Autre: 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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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Effect of tDCS combined with aerobic exercise on exercise performance in healthy individuals.
Délai: 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.
Délai: 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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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Effect of tDCS combined with aerobic exercise on isokinetic muscle strength in healthy individuals.
Délai: 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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Autres mesures de résultats
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Changes in SF-36 questionnaire of quality of life
Délai: 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
Délai: 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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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Les enquêteurs
- Directeur d'études: Mine Gulden Polat, PhD, Marmara University
- Chaise d'étude: Lutfu Hanoglu, PhD, Medipol University
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Anticipé)
1 mars 2020
Achèvement primaire (Anticipé)
29 octobre 2021
Achèvement de l'étude (Anticipé)
29 décembre 2021
Dates d'inscription aux études
Première soumission
19 décembre 2019
Première soumission répondant aux critères de contrôle qualité
23 décembre 2019
Première publication (Réel)
26 décembre 2019
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
27 janvier 2020
Dernière mise à jour soumise répondant aux critères de contrôle qualité
22 janvier 2020
Dernière vérification
1 décembre 2019
Plus d'information
Termes liés à cette étude
Autres numéros d'identification d'étude
- 09.2019.669
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Non
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Non
Étudie un produit d'appareil réglementé par la FDA américaine
Non
produit fabriqué et exporté des États-Unis.
Non
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