Protocol summary

Summary
The main aim of this randomized controlled trial is to study the effects of a structured injury prevention program, 11+, on Sport injury rate among youth male soccer players between 14 and 18 years of age. For these purpose 980 players from Thirty-five teams under 18 participated in this study. The teams randomly assigned into the 11+ group and control group. Training-group subjects participate in a 30-wk FIFA comprehensive warm up program 11+ that included plyometrics, core muscle strengthening, balance, and running exercises. These exercises perform at least twice a week as warm up. The control group performs their routine training. All soccer-related injuries and player exposure to practice sessions and matches was registered prospectively by the coaches and medical staffs.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2012073110467N1
Registration date: 2015-07-21, 1394/04/30
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2015-07-21, 1394/04/30
Registrant information
Name
Mostafa Zarei
Name of organization / entity
University of Tehran
Country
Iran (Islamic Republic of)
Phone
+98 21 4473 9131
Email address
zareeimostafa@ut.ac.ir
Recruitment status
Recruitment complete
Funding source
Sport Science Research Institute of Iran
Expected recruitment start date
2011-06-22, 1390/04/01
Expected recruitment end date
2013-02-19, 1391/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of FIFA comprehensive warm-up 11+ program on injuries incidence of Iranian young male soccer players
Public title
The effect of FIFA 11+ program on injury incidence of young soccer players
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: All teams should be have at least two training session per week; Teams should be participated in Asia vision priemier league; At start of study, all players should be at 14-18 years old. Exclusion criteria: Neuromuscular disorders; Having any rehabilitation program such as wobble board exercise or lower exercise taping.
Age
From 14 years old to 18 years old
Gender
Male
Phase
2
Groups that have been masked
No information
Sample size
Target sample size: 980
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
University of Tehran
Street address
University of Tehran, Enghelab Sq, Tehran, Iran
City
Tehran
Postal code
1439813117
Approval date
2011-04-21, 1390/02/01
Ethics committee reference number
M/140490

Health conditions studied

1

Description of health condition studied
Injuries to the ankle and foot
ICD-10 code
S90
ICD-10 code description
Superficial injury of ankle and foot

2

Description of health condition studied
Injuries to the knee and lower leg
ICD-10 code
s80
ICD-10 code description
Superficial injury of lower leg

3

Description of health condition studied
Unspecified multiple injuries
ICD-10 code
T07
ICD-10 code description
Unspecified multiple injuries

Primary outcomes

1

Description
Sports-related lower extremity injuries
Timepoint
Two weeks after intervention
Method of measurement
Injury report form (fuller et al. 2006)

Secondary outcomes

1

Description
Dynamic Balance
Timepoint
pre and post
Method of measurement
Star excursion test

Intervention groups

1

Description
Teams in the intervention group performed the +11 at least twice in week as warm up prior training throughout the season.
Category
Prevention

2

Description
All participants of the control group continued their practice sessions as usual
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
Iran National Football Academy Sport Medicine Center
Full name of responsible person
Mr Kaseri
Street address
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Sport Science Research Institute of Iran
Full name of responsible person
Dr Fariba Mohammadi
Street address
No. 3, 5th Alley, Miremad Street, Motahhari Street, Tehran, Iran
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Sport Science Research Institute of Iran
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
Shahid Beheshti University
Full name of responsible person
Mostafa Zarei
Position
Assistant Professor
Other areas of specialty/work
Street address
Shahid Beheshti University, Evin, Tehran, Iran
City
Tehran
Postal code
Phone
+98 21 2243 1963
Fax
002144739106
Email
zareeimostafa@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahid Beheshti University
Full name of responsible person
Mostafa Zarei
Position
PhD
Other areas of specialty/work
Street address
Shahid Beheshti University, Evin, Tehran, Iran
City
Tehran
Postal code
Phone
+98 21 2243 1963
Fax
Email
zareeimostafa@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Full name of responsible person
Mostafa Zarei
Position
Other areas of specialty/work
Street address
City
Tehran
Postal code
Phone
Fax
Email
zareeimostafa@yahoo.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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