Protocol summary

Study aim
Investigating the effects of 10 weeks functional training on some risk factors of lower extremity injuries in youth male soccer players,
Design
A randomized two group intervention with intervention in the experimental group and without intervention in the control group in 30 youth male football players, pre test and post test in both groups (before and after intervention in the experimental group) with Permuted block randomization method.
Settings and conduct
All subjects participate in the pre test. Then, the control group subjects continue to practice their soccer practice while the experimental group participates in the functional training program for 10 weeks. The post test is carried out like pre test.
Participants/Inclusion and exclusion criteria
Inclusion: Age range from 14 to 16 years old with at least three years of playing experience; membership in the current teams of football league in Kerman province; participate in at least four to six activity sessions per week. Exclusion: Certain medical conditions that prevent their presence in the research; any injury that prevents them from attending the training or competition within 30 days; recent surgical history that limit their presence.
Intervention groups
Intervention group: The intervention group will conduct ten weeks of functional training (3 sessions weekly and each session will run for 90 minutes) after pre test. After ten weeks the intervention group will undergo the same test with the pre test. Control group: After performing a pre test, the control group will continue usual training without performing a intervention program. After ten weeks, control group will undergo the same test with the pre test.
Main outcome variables
Risk factors of lower extremity injuries, General sport performance tests (speed, agility, power, balance and strength), Specific sport performance test, McGill protocol test.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20160623028597N2
Registration date: 2018-04-02, 1397/01/13
Registration timing: retrospective

Last update: 2018-04-02, 1397/01/13
Update count: 0
Registration date
2018-04-02, 1397/01/13
Registrant information
Name
Reza Siamaki Gharieh Saf
Name of organization / entity
PhD student, Department of Sports Injuries and Corrective Exercises, Faculty of Sports Sciences, Uni
Country
Iran (Islamic Republic of)
Phone
+98 21 8835 1730
Email address
siamaki.reza@ut.ac.ir
Recruitment status
Recruitment complete
Funding source
Investigator
Expected recruitment start date
2016-07-22, 1395/05/01
Expected recruitment end date
2016-12-21, 1395/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effects of 10 weeks functional training on some risk factors of lower extremity injuries and sport performance in young male soccer players
Public title
The effects of functional training on injury risk factors and sport performance in young male soccer players
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Age range from 14 to 16 years old with at least three years of playing experience; membership in the current teams of football league in Kerman province; participate in at least four to six activity sessions per week.
Exclusion criteria:
Certain medical conditions that prevent their presence in the research; any injury that prevents them from attending the training or competition within 30 days; recent surgical history that limit their presence; serious or clear malalingment in in the limbs and trunk.
Age
From 81 years old to 79 years old
Gender
Male
Phase
N/A
Groups that have been masked
  • Participant
Sample size
Target sample size: 30
Randomization (investigator's opinion)
Randomized
Randomization description
Permuted block randomization.
Blinding (investigator's opinion)
Single blinded
Blinding description
Blinding will be done for subjects only. They will be informed about the process and the various stages of conducting a research and agreeing to be present in the research, but they will remain unaware of the content of the training program and the probable outcome of the investigation.
Placebo
Not used
Assignment
Parallel
Other design features
The randomization method will be permuted block randomization; Research will also be important in sport injury prevention field.

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Tehran University of Medical Sciences.
Street address
Between 15th and 16th St., North Kargar st., Tehran, Islamic Republic.
City
Tehran
Province
Tehran
Postal code
14155-6619
Approval date
2018-02-04, 1396/11/15
Ethics committee reference number
IR.ut.Sport.REC.1396003

Health conditions studied

1

Description of health condition studied
some risk factors of lower extremity injuries
ICD-10 code
-----
ICD-10 code description
-----

Primary outcomes

1

Description
Risk factors of lower extremity injuries
Timepoint
Pre intervention, after 10 weeks intervention
Method of measurement
LESS test

2

Description
General sport performance
Timepoint
Pre intervention, after 10 weeks intervention
Method of measurement
Sprint test, agility test, power test, balance test, strength test.

3

Description
Sport-Specific Performance
Timepoint
Pre intervention, after 10 weeks intervention
Method of measurement
SDT test

Secondary outcomes

1

Description
McGill Protocol
Timepoint
Pre intervention, after 10 weeks intervention
Method of measurement
Core test

Intervention groups

1

Description
Intervention group: The intervention group will conduct ten weeks of functional training after pre test. Functional training is designed using the principles of training science and depending on its variables (intensity, repetition, set, rest) which incl
Category
Other

2

Description
Control group: After performing a pre test, the control group will continue usual training without performing a intervention program. After ten weeks, control group will undergo the same test with the pre test.
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Shahid Bahonar University
Full name of responsible person
Reza siamaki Gharie Safa
Street address
Imam Khomeini Highway, Research Square, Shahid Bahonar University
City
Kerman
Province
Kerman
Postal code
7617768855
Phone
+98 34 3251 4486
Fax
Email
siamaki.reza@ut.ac.ir
Web page address

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Investigator
Full name of responsible person
Reza Siamaki Gharieh Saf
Street address
Between 15th and 16th St., North Kargar st., Tehran, Islamic Republic.
City
Tehran
Province
Tehran
Postal code
141556619
Phone
+98 21 8835 1730
Email
siamaki.reza@ut.ac.ir
Grant name
-----
Grant code / Reference number
-----
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Investigator
Proportion provided by this source
100
Public or private sector
Private
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
Faculty of Sports Sciences, University of Tehran
Full name of responsible person
Reza Siamaki Gharieh Safa
Position
PhD Student
Latest degree
Master
Other areas of specialty/work
Others
Street address
Between 15th and 16th St., North Kargar st., Tehran, Islamic Republic.
City
Tehran
Province
Tehran
Postal code
76177-68855
Phone
+98 34 3251 4486
Fax
+98 34 3251 4486
Email
siamaki.reza@ut.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Faculty of Sports Sciences, University of Tehran
Full name of responsible person
Reza Siamaki Gharieh Safa
Position
PhD Student
Latest degree
Master
Other areas of specialty/work
Others
Street address
Between 15th and 16th St., North Kargar st., Tehran, Islamic Republic.
City
Tehran
Province
Tehran
Postal code
76177-68855
Phone
+98 34 3251 4486
Fax
+98 34 3251 4486
Email
siamaki.reza@ut.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Faculty of Sports Sciences, University of Tehran
Full name of responsible person
Reza Siamaki Gharieh Safa
Position
PhD Student
Latest degree
Master
Other areas of specialty/work
Sport injuries and corrective exercise
Street address
Between 15th and 16th St., North Kargar st., Tehran, Islamic Republic.
City
Tehran
Province
Tehran
Postal code
76177-68855
Phone
+98 34 3251 4486
Fax
+98 34 3251 4486
Email
Siamaki.reza@ut.ac.ir
Web page address

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
Not applicable
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
The total potential data can be shared after unidentifiable individuals.
When the data will become available and for how long
Start the access period 6 months after printing the results.
To whom data/document is available
Data will be available to researchers and students, athletes and coaches.
Under which criteria data/document could be used
There are no other conditions for using data or documentation.
From where data/document is obtainable
Reza Siamaki Gharieh Safa via the contact number 09153826319 and email siamaki.reza@ut.ac.ir.
What processes are involved for a request to access data/document
Submit an application to the email address siamaki.reza@ut.ac.ir.
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