a-tDCS Combined With Aerobic Exercise in Healthy Individuals

NCT04211779 | Unknown

• 1 other identifier: 09.2019.669
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Healthy

Keywords

Transcranial Direct Current Stimulation; Aerobic Exercise; Performance

Outcome Measures

Primary Outcomes (2)

• Effect of tDCS combined with aerobic exercise on exercise performance in healthy individuals.

  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.

  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

Secondary Outcomes (1)

• Effect of tDCS combined with aerobic exercise on isokinetic muscle strength in healthy individuals.

  2 months

Other Outcomes (2)

• Changes in SF-36 questionnaire of quality of life

  2 months

• Changes in Cognitive Test Battery

  2 months

Study Arms (3)

Real tDCS and Exercise

EXPERIMENTAL

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.

Device: Real tDCS; Other: Exercise

Sham tDCS and Exercise

SHAM COMPARATOR

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.

Device: Sham tDCS; Other: Exercise

Exercise

OTHER

Exercise group in which will receive the active intervention of aerobic exercise training no tDCS intervention.

Other: Exercise

Interventions

Real tDCS DEVICE

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.

Real tDCS and Exercise

Sham tDCS DEVICE

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.

Sham tDCS and Exercise

Exercise OTHER

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.

Exercise; Real tDCS and Exercise; Sham tDCS and Exercise

Eligibility Criteria

• Age: 20 Years - 25 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Marmara University: lead

Study Sites (1)

Marmara University

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Interventions

Exercise

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Mine Gülden Polat, PhD

  Marmara University

  STUDY DIRECTOR

• Lütfü Hanoğlu, PhD

  Medipol University

  STUDY CHAIR

Central Study Contacts

Bahar Ayberk, MSc

CONTACT

00902164140545; bahar.ayberk@marmara.edu.tr

Mine Gülden Polat, PhD

CONTACT

00902164140545; gpolat@marmara.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 19, 2019
• First Posted: December 26, 2019
• Study Start: March 1, 2020
• Primary Completion: October 29, 2021
• Study Completion: December 29, 2021
• Last Updated: January 27, 2020

Record last verified: 2019-12

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)