Protocol summary

Study aim
Assessment of performance in elite athletes (bodybuilders) through transcranial direct current stimulation; A quantitative electroencephalography and surface electromyography included investigation
Design
Two arm parallel group randomised trial with blinded postoperative care and outcome assessment.
Settings and conduct
40 professional bodybuilders were randomly assigned to two arms receiving either sham or real tDCS for 13 minutes in the first session. After 72 hours, both groups received the inverse stimulation. After the brain stimulation, cerebral hemodynamic response (using frontopolar hemoencephalography) was examined upon taking three computer-based cognitive tasks i.e. reasoning, memory and verbal ability using the Cambridge Brain Science-Cognitive Platform. Subsequently, the bodybuilders performed knee extension exercise while performance indicators including maximal muscular strength (1RM), muscular endurance (SEI), heart rate (ECG), motivation (VAS), surface electromyography over quadriceps femoris muscle (sEMG) and perceived exertion (RPE) were evaluated.
Participants/Inclusion and exclusion criteria
Those who enrolled in the study were males aging 18 to 40 with weight between 60 to 120 kg who were regularly training weightlifting exercise (at least 3 times a week) not on doping drugs for at least 3 months prior to enrollment.
Intervention groups
Sham and tDCS
Main outcome variables
Investigation of Transcranial Direct Current Stimulation in athletes

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20181104041543N1
Registration date: 2018-12-23, 1397/10/02
Registration timing: retrospective

Last update: 2018-12-23, 1397/10/02
Update count: 0
Registration date
2018-12-23, 1397/10/02
Registrant information
Name
Ali-Mohammad Kamali
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 3628 8814
Email address
ali.kamali321@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-04-03, 1396/01/14
Expected recruitment end date
2018-10-22, 1397/07/30
Actual recruitment start date
2017-04-03, 1396/01/14
Actual recruitment end date
2018-11-04, 1397/08/13
Trial completion date
2018-11-04, 1397/08/13
Scientific title
Assessment of performance in elite athletes (bodybuilders) through transcranial direct current stimulation; A quantitative electroencephalography and surface electromyography included investigation
Public title
Assessment of performance in elite athletes through transcranial direct current stimulation
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
males aging 18 to 40 not on doping drugs for at least 3 months prior to enrollment. Weight between 60 to 120 kg who were regularly training weightlifting exercise (at least 3 times a week) The participants were assured not to have psychological or neurological disorders or a history of alcohol or drug use.
Exclusion criteria:
Age
From 18 years old to 40 years old
Gender
Male
Phase
N/A
Groups that have been masked
  • Participant
  • Investigator
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 40
Actual sample size reached: 40
Randomization (investigator's opinion)
Randomized
Randomization description
A researcher who was blinded to data collection process randomly assigned the participants to sham and real tDCS arms using consecutive randomization.
Blinding (investigator's opinion)
Double blinded
Blinding description
A researcher who was blinded to data collection process randomly assigned the participants to sham and real tDCS arms using consecutive randomization.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Shiraz University of Medical Sciences
Street address
School of Medicine, Imam Hussain Square, Zand St., Shiraz, Iran
City
Shiraz
Province
Fars
Postal code
7184737798
Approval date
2017-04-03, 1396/01/14
Ethics committee reference number
IR.SUMS.REC.1396.147

Health conditions studied

1

Description of health condition studied
Transcranial Direct Current Stimulation to Enhance Athletic Performance Outcome in Professional Bodybuilders
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
One-Repetition Maximum (1RM)
Timepoint
Data were obtained over two sessions with the interval of 72 hours
Method of measurement
Epley formula

2

Description
Surface Electromyography (sEMG)
Timepoint
Data were obtained over two sessions with the interval of 72 hours
Method of measurement
Electromyography divice

3

Description
Heart Rate (HR) recording
Timepoint
Data were obtained over two sessions with the interval of 72 hours
Method of measurement
Electrocardiography

4

Description
Cognitive performance
Timepoint
Data were obtained over two sessions with the interval of 72 hours
Method of measurement
Cambridge Brain Science Cognitive Platform

5

Description
Brain map
Timepoint
Data were obtained over two sessions with the interval of 72 hours
Method of measurement
Quantitative electroencephalography

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Transcranial Direct Current Stimulation
Category
Rehabilitation

2

Description
Control group: Placebo stimulants
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Bodybuilding gyms across the city of Shiraz
Full name of responsible person
Mohammad Nami
Street address
School of Medicine, Imam Hussain Square, Zand St., Shiraz, Iran
City
Shiraz
Province
Fars
Postal code
71348-14336
Phone
+98 71 3628 8814
Email
ali.kamali321@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Younes Ghasemi
Street address
Central building of Shiraz University of Medical Sciences Zand St., Shiraz, Iran
City
Shiraz
Province
Fars
Postal code
71348-14336
Phone
+98 71 3230 5410
Email
vcrdep@sums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Ali-Mohammad Kamali
Position
PhD candidate
Latest degree
Master
Other areas of specialty/work
Neuroscience
Street address
Alley 3, Sattarkhan Street,
City
Shiraz
Province
Fars
Postal code
7184737798
Phone
+98 71 3628 8814
Fax
Email
ali.kamali321@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Ali-Mohammad Kamali
Position
PhD candidate
Latest degree
Master
Other areas of specialty/work
Neuroscience
Street address
Alley 3, Sattarkhan Street,
City
Shiraz
Province
Fars
Postal code
7184737798
Phone
+98 71 3628 8814
Fax
Email
ali.kamali321@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Ali-Mohammad Kamali
Position
PhD candidate
Latest degree
Master
Other areas of specialty/work
Neuroscience
Street address
Alley 3, Sattarkhan Street,
City
Shiraz
Province
Fars
Postal code
7184737798
Phone
+98 71 3628 8814
Fax
Email
ali.kamali321@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
The all potential data can be shared after unidentifiable people
When the data will become available and for how long
Six months after the publication of the article
To whom data/document is available
Only for researchers
Under which criteria data/document could be used
For research
From where data/document is obtainable
ali.kamali321@gmail.com
What processes are involved for a request to access data/document
10 Day
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