1. Home
  2. Approved trials
  3. » فارسی

The effects of acute non-invasive brain stimulation on cognitive and executive functions in one bout of exhaustive endurance activity in semi-endurance runners

Protocol summary

Study aim
Determining the effects of acute non-invasive brain stimulation on cognitive and executive functions in a single bout of endurance activity in semi-endurance runners.
Design
The clinical trial had two control and sham groups, in order to randomize the order of subject exposure to two different conditions, the website www.randomization.com was used.
Settings and conduct
Attending the laboratory and performing cognitive tests, then, the target area to install the electrodes will be marked using a special EEG cap, and then the electrodes will be installed in the marked areas. To stimulate the left DLPFC area, the anode electrode will be installed in the F3 area and the cathode electrode will be installed in the AF8 area. In the sham stimulation mode, the method of recording the electrodes will be similar to the active stimulation mode
Participants/Inclusion and exclusion criteria
Criteria for entering the research: 1) More than 3 years of active experience in the field of endurance biathlon 2) Age range from 18 to 35 years 3) Body mass index (BMI) 18.5 to 24.9 kilograms per square meter of height 4) Not suffering from color blindness or color vision disorders 5) Being right-handed Criteria for not entering the research: 1) Suffering from any cardiovascular, pulmonary and metabolic diseases 2) history of seizures, epilepsy or other types of neurological diseases 3) The presence of implantable devices or pacemakers in the body 4) Smoking and alcohol consumption
Intervention groups
Subjects will be cross-exposed to two brain stimulation conditions including 1) anodal stimulation of the DLPFC region and 2) sham stimulation.
Main outcome variables
Effect on time to physical exhaustion, heart rate, working memory performance, selective reaction time, bimanual coordination, "countdown" cognitive test, runners' sense of pain, runners' sense of pleasure, rate of perception of pressure (RPE).

General information

Reason for update
Acronym
ETDCSESER
IRCT registration information
IRCT registration number: IRCT20230629058614N1
Registration date: 2023-12-20, 1402/09/29
Registration timing: retrospective

Last update: 2023-12-20, 1402/09/29
Update count: 0
Registration date
2023-12-20, 1402/09/29
Registrant information
Name
Mahdi Esmaeili
Name of organization / entity
Razi University of Kermanshah
Country
Iran (Islamic Republic of)
Phone
+98 83 3836 2077
Email address
m.esmaeili@stu.razi.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-05-05, 1402/02/15
Expected recruitment end date
2023-06-22, 1402/04/01
Actual recruitment start date
2023-06-05, 1402/03/15
Actual recruitment end date
2023-07-23, 1402/05/01
Trial completion date
2023-07-23, 1402/05/01
Scientific title
The effects of acute non-invasive brain stimulation on cognitive and executive functions in one bout of exhaustive endurance activity in semi-endurance runners
Public title
The effects of acute non-invasive brain stimulation on cognitive and executive functions in one bout of exhaustive endurance activity in semi-endurance runners
Purpose
Other
Inclusion/Exclusion criteria
Inclusion criteria:
1) More than 3 years of active experience in the field of endurance biathlon 2) Age range from 18 to 35 years 3) Body mass index (BMI) 18.5 to 24.9 kilograms per square meter of height 4) Not suffering from color blindness or color vision disorders 5) Being right-handed
Exclusion criteria:
1) Suffering from any cardiovascular, pulmonary and metabolic diseases 2) history of seizures, epilepsy or other types of neurological diseases 3) The presence of implantable devices or pacemakers in the body 4) Smoking and alcohol consumption
Age
From 18 years old to 35 years old
Gender
Male
Phase
3
Groups that have been masked
  • Participant
  • Investigator
Sample size
Target sample size: 18
Actual sample size reached: 14
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization method and description of each method: simple randomization, block (Subjects will be cross-exposed to two brain stimulation conditions including 1) DLPFC anodal stimulation and 2) sham stimulation.)
Blinding (investigator's opinion)
Double blinded
Blinding description
Subjects and the main researcher will not be aware of the type of stimulation received in each session, and this information will only be available to someone outside the research team until the end of the research. In order to hide the order of receiving stimulation from the main researcher, all the steps related to the random determination of the order of receiving stimulation in each subject will be performed by the same person outside the research team. Also, in order to hide the type of stimulation in each session from the subjects, the TDCS device is hidden from the eyes of the subjects with a mask and the main researcher will not be present in the laboratory during the installation of the electrodes and at the end of 20 minutes and the time of removing the electrodes.
Placebo
Used
Assignment
Crossover
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Razi University
Street address
Kermanshah, Taq Bostan, University St., Razi University, Deputy Research Area
City
Kermanshah
Province
Kermanshah
Postal code
6714414874
Approval date
2023-06-10, 1402/03/20
Ethics committee reference number
IR.RAZI.REC.1402.018

Health conditions studied

1

Description of health condition studied
The effect of acute non-invasive brain stimulation on cognitive and executive functions in a single bout of endurance exercise.
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Changes in bimanual coordination
Timepoint
Measurement of bimanual coordination at the beginning of the study in the first week (before the start of the intervention), measurement of bimanual coordination 20 minutes after stimulation, measurement of bimanual coordination one week after the first intervention and before the sham intervention in the second week, measurement Bimanual coordination 20 minutes after sham intervention (unrealistic stimulation) in the second week.
Method of measurement
Lafayette company's two-handed coordination tool

2

Description
Reaction Time
Timepoint
Measurement of reaction time at the beginning of the study in the first week (before the start of the intervention), measurement of reaction time 20 minutes after stimulation, measurement of reaction time one week after the first intervention and before sham intervention in the second week, measurement of reaction time 20 minutes after From sham intervention (unreal stimulation) in the second week.
Method of measurement
Reaction time device Response Panel (63035A, Lafayette, Indiana)

3

Description
working memory
Timepoint
Measurement of working memory at the beginning of the study in the first week (before the start of the intervention), measurement of working memory 20 minutes after stimulation, measurement of working memory one week after the first intervention and before sham intervention in the second week, measurement of working memory 20 minutes After sham intervention (unreal stimulus) in the second week.
Method of measurement
Stroop word-color test

4

Description
Rate of perceived pressure (RPE)
Timepoint
During the execution of sub-maximal endurance activity, every 3 minutes, the level of perceived pressure is announced and recorded by the subjects. The average pressure perception in each training session is calculated and used for analysis.
Method of measurement
From the image of the Borg scale (0 – 100; RPE)

5

Description
Feeling scale to measure the feeling of pleasure (perceptual response)
Timepoint
During the performance of the sub-maximal endurance activity, every 3 minutes the level of pleasure is declared and recorded by the subjects. The average level of pleasure in each training session is calculated and used for analysis.
Method of measurement
An 11-item emotion scale is used, the answers of which are recorded and analyzed in the range of +5 to -5.

6

Description
Visual analog scale to measure pain sensation
Timepoint
During the performance of sub-maximal endurance activity, the pain level is declared and recorded by the subjects every 3 minutes. The average level of pain sensation in each training session is calculated and used for analysis.
Method of measurement
A 0-10 visual analog scale is used to measure pain

7

Description
Perceived arousal scale to measure arousal (perceptual response)
Timepoint
During the performance of submaximal endurance activity, the level of arousal is announced and recorded by the subjects every 3 minutes. The average level of arousal in each training session is calculated and used for analysis.
Method of measurement
A 6-item scale of perceived arousal is used

8

Description
Countdown cognitive test
Timepoint
During the performance of the endurance activity, when the subject reaches the pressure perception level of 70 on the Borg scale, a countdown cognitive test will be performed.
Method of measurement
During the performance of the endurance activity, in the 4th, 8th and 12th kilometers, a number from 200 to 300 will be randomly announced by the test taker and the test taker will be asked to say loudly for 1 minute. Count backwards and with a distance of 3 from the announced number, then the total number of numbers read by the subject and the number of correct numbers from the total numbers are calculated and used for analysis.

9

Description
اندازه گیری ضربان قلب در حین اجرای فعالیت استقامتی
Timepoint
During the performance of sub-maximal endurance activity, the heart rate is announced and recorded by the subjects every 3 minutes. The average heart rate in each training session is calculated and used for analysis.
Method of measurement
Polar heart rate monitor (made in Finland)

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: 14 adult semi-endurance male runners, members of the Kermanshah athletics team. The first session will be used to familiarize the subjects with the research process, the method of applying interventions and measuring variables and primary measurements. Then the subjects will be present in the laboratory in 3 separate sessions with an interval of at least 5 days between the sessions. The second session will be for the purpose of measuring the maximum aerobic speed and the next two sessions will be for the purpose of applying interventions and measuring the desired variables. in the third and fourth sessions; Subjects will be randomly exposed to two types of brain stimulation for 20 minutes, including 1) anodal stimulation of the left posterolateral prefrontal cortex (DLPFC) and 2) sham stimulation.
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Kermanshah athletics team
Full name of responsible person
Ahmad Roshanzadeh
Street address
Kermanshah, Shahid Beheshti Blvd., Kermanshah Azadi Stadium, Kermanshah Province Athletics Committee
City
Kermanshah
Province
Kermanshah
Postal code
6714663171
Phone
+98 83 3835 5992
Fax
+98 83 3835 7397
Email
m.esmaeili2911@gmail.com
Web page address

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Razi University of Kermanshah
Full name of responsible person
Dr. Mohammad Nabi Ahmadi
Street address
Taq Bostan, University Street
City
Kermanshah
Province
Kermanshah
Postal code
6714414971
Phone
+98 83 3427 4515
Fax
Email
m.esmaeili.2911@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Razi University of Kermanshah
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
Razi University
Full name of responsible person
Mehdi esmaili
Position
Masters student
Latest degree
Bachelor
Other areas of specialty/work
Learning and motor control
Street address
Faculty of Sports Sciences, Razi University, Taq Bostan, University St., Kermanshah, Iran
City
Kermanshah
Province
Kermanshah
Postal code
6714414971
Phone
+98 83 3836 2077
Email
m.esmaeili.2911@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Razi University of Kermanshah
Full name of responsible person
Mehdi esmaili
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Learning and motor control
Street address
Faculty of Sports Sciences, Razi University, University St., Taq Bostan, Kermanshah
City
Kermanshah
Province
Kermanshah
Postal code
6714414971
Phone
+98 83 3845 8428
Email
m.esmaeili.2911@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Razi University of Kermanshah
Full name of responsible person
Mehdi esmaili
Position
Masters student
Latest degree
Bachelor
Other areas of specialty/work
Learning and motor control
Street address
Faculty of Sports Sciences, Razi University, University St., Taq Bostan, Kermanshah
City
Kermanshah
Province
Kermanshah
Postal code
6714414971
Phone
+98 83 3845 8428
Email
m.esmaeili.2911@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
Not applicable
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
Not applicable
Title and more details about the data/document
All data can be shared after de-identifying subjects.
When the data will become available and for how long
3 months after printing the results
To whom data/document is available
All people if they submit an official request
Under which criteria data/document could be used
Requesting access to data for any purpose is permitted.
From where data/document is obtainable
If you need to receive documents, contact Mehdi Esmaeili, a master's student at Razi University of Kermanshah, by email: m.esmaeili.2911@gmail.com.
What processes are involved for a request to access data/document
In case of submitting an official request, announcing the relevant reasons and mentioning the complete details, the data will be announced via email after 72 hours.
Comments
Loading...