a-tDCS Combined With Aerobic Exercise in Healthy Individuals
22 de enero de 2020 actualizado por: 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.
Descripción general del estudio
Estado
Desconocido
Condiciones
Intervención / Tratamiento
Descripción detallada
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.
Tipo de estudio
Intervencionista
Inscripción (Anticipado)
21
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
-
-
-
İstanbul, Pavo
- Marmara University
-
-
Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
20 años a 25 años (Adulto)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Masculino
Descripción
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 de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Ciencia básica
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Triple
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: 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.
|
|
Comparador falso: 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.
|
|
Otro: 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.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Effect of tDCS combined with aerobic exercise on exercise performance in healthy individuals.
Periodo de tiempo: 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.
Periodo de tiempo: 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
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Effect of tDCS combined with aerobic exercise on isokinetic muscle strength in healthy individuals.
Periodo de tiempo: 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
|
Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Changes in SF-36 questionnaire of quality of life
Periodo de tiempo: 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
Periodo de tiempo: 2 months
|
An n-back cognitive test will be conducted for assessing the working memory.
|
2 months
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Director de estudio: Mine Gulden Polat, PhD, Marmara University
- Silla de estudio: Lutfu Hanoglu, PhD, Medipol University
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Anticipado)
1 de marzo de 2020
Finalización primaria (Anticipado)
29 de octubre de 2021
Finalización del estudio (Anticipado)
29 de diciembre de 2021
Fechas de registro del estudio
Enviado por primera vez
19 de diciembre de 2019
Primero enviado que cumplió con los criterios de control de calidad
23 de diciembre de 2019
Publicado por primera vez (Actual)
26 de diciembre de 2019
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
27 de enero de 2020
Última actualización enviada que cumplió con los criterios de control de calidad
22 de enero de 2020
Última verificación
1 de diciembre de 2019
Más información
Términos relacionados con este estudio
Otros números de identificación del estudio
- 09.2019.669
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
No
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
producto fabricado y exportado desde los EE. UU.
No
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .
Ensayos clínicos sobre Real tDCS
-
Massachusetts General HospitalReclutamientoDolor crónicoEstados Unidos
-
The University of Hong KongThe Hong Kong Polytechnic UniversityTerminadoCarrera | DisartriaHong Kong
-
The Hong Kong Polytechnic UniversityReclutamientoCarrera | AfasiaHong Kong
-
IRCCS Fondazione Stella MarisTerminado
-
The Hong Kong Polytechnic UniversityThe University of Hong Kong; University of Magdeburg; University of WaterlooReclutamiento
-
First Affiliated Hospital of Zhejiang UniversityTerminadoTrastorno de la concienciaPorcelana
-
Assistance Publique - Hôpitaux de ParisReclutamientoFatiga en la esclerosis múltipleFrancia
-
University Hospital of FerraraTerminadoEstado de mínima conciencia | LCTItalia
-
University College London HospitalsTerminado
-
Hebrew SeniorLifeTerminadoEnvejecimiento | Otoño | Caída Accidental | Marcha, InestableEstados Unidos