Protocol summary

Summary
The study will take place in Football Academy and Rasoul Akram Hospital in Tehran. Eligibility Criteria for participation include : male soccer players , no history of substance abuse ,no history of chronic alcohol abuse ,no history of epilepsy , encephalitis, meningitis and any systemic disease. The thirty participants will test by CANTAB (Cambridge Neuropsychological test Automated Battery) . Working memory will test by SWM (Spatial Working Memory ) , Attention will test by RVP ( Rapid Visual Information Processing ) and SRT ( Simple Reaction Time ). Thirty athletes (30 men ) will randomly assigne to a study group (i.e. computer base cognitive training ) or a control group . Cognitive training group will recruite N-Bank for 30 minutes, 3 days a week for 25 sessions . During the study participants will exclude if thay have any acute systemic illness , sport related and non-sport related concussion . At the end of the twenty-fifth session participants will evaluate by the same test ( CANTAB Test) .Participants will fallow six months , after six month reevaluate by CANTAB test .

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201306184251N11
Registration date: 2013-08-25, 1392/06/03
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2013-08-25, 1392/06/03
Registrant information
Name
Haleh Dadgostar
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 2200 4050
Email address
dadgostar.h@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences
Expected recruitment start date
2013-07-23, 1392/05/01
Expected recruitment end date
2014-02-20, 1392/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Cognintive Training Effect on Neurocognitive Function in Elite Soccer Player
Public title
Cognintive Training Effect on Neurocognitive Function in Elite Soccer Player
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion Criteria:Elite male soccer players ;No history of substance abuse; No history of chronic alcohol abuse ;No history of epilepsy , encephalitis, meningitis and any systemic disease Exclusion Criteria: Acute systemic illness during the study; Related and non-sport related concussion during the study;Not wanting to continue
Age
From 15 years old to 40 years old
Gender
Male
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 30
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Tehran University of Medical Sciences
Street address
Ghods St, Keshavarz Blvd
City
tehran
Postal code
1417614411
Approval date
2010-09-23, 1389/07/01
Ethics committee reference number
21713

Health conditions studied

1

Description of health condition studied
Neurocognitive Function
ICD-10 code
G94.8
ICD-10 code description
Other specified disorders of brain in diseases classified elsewhere

Primary outcomes

1

Description
Working memory(Spatial Working Memory)
Timepoint
Pretraining/ Post cognitive training end of 25th session/After 6 month
Method of measurement
Measurement by CANTAB test

2

Description
Attention (Rapid Visual Information Processing )
Timepoint
Pretraining/ post training end of 25th session/After 6 month
Method of measurement
Measurement by CANTAB test

3

Description
Attention( Simple Reaction Time)
Timepoint
Pretraining/ post training end of 25th session/After 6 month
Method of measurement
By CANTAB test

Secondary outcomes

1

Description
Age
Timepoint
Initial
Method of measurement
ID card

2

Description
Degree
Timepoint
Initial
Method of measurement
check list

3

Description
Position on the field of play
Timepoint
Initial
Method of measurement
Check List

Intervention groups

1

Description
Target group of cognitive training (computer_based cognitive training ) N-Bank for 30 minutes, 3 days a week for 25 sessions .
Category
Other

2

Description
No intervention for control group.
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Football Academy
Full name of responsible person
Haleh Dadgostar
Street address
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Haleh Dadgotar
Street address
Shahr Ara ,Sattar khan, Rasoul Akram Hospital ,Sports Medicine Clinic
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Haleh Dadgotar
Position
Assistant Professor
Other areas of specialty/work
Street address
Shahr Ara ,Sattar khan, Rasoul Akram Hospital ,Sports Medicine Clinic
City
Tehtan
Postal code
Phone
+98 21 6435 2446
Fax
Email
hldadgostar@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Haleh Dadgostar
Position
Assistant Professor
Other areas of specialty/work
Street address
Sattar khan, Shahr Ara, Rasoul Akram Hospital ,Sports Medicine Clinic
City
Tehran
Postal code
Iran
Phone
+98 21 6436 2446
Fax
Email
hldadgostar@gmail.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Haleh Dadgostar MD
Position
Assistant Professor
Other areas of specialty/work
Street address
Sattar khan ,Shahr ara, Rasoul Akram Hospital ,Sports Medicine clinic
City
Tehran
Postal code
Phone
+98 21 6435 2446
Fax
Email
hldadgostar@gmail.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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