Protocol summary

Study aim
The aim of the present study is to compare the effect of 8 weeks of a comprehensive FIFA 11+ warm-up program and playing on small sided games on knee isokinetic strength and balance in professional soccer players.
Design
A controlled clinical trial with parallel groups, no blinding, cluster and simple randomization, non-blinded phase, on 60 patients. A lottery method is used for randomization.
Settings and conduct
The study will be conducted in two phases, pre- and post-test, in the Shahid Beheshti University laboratory, and the training intervention will be followed on Payam turf. Assessments will include isokinetic strength testing and balance with the Biodex device.
Participants/Inclusion and exclusion criteria
Professional football players in Tehran with at least three years of football experience without injury or surgery in the lower extremities within the past 6 months, aged 18 to 21 (youth and promising) and working in the first and top leagues of Tehran will be considered as the statistical population.
Intervention groups
The individuals in the FIFA 11+ group will perform the FIFA 11+ comprehensive warm-up program before their main training session for three sessions per week for eight weeks, while the individuals in the small-field group will perform the small-field-based warm-up program before their main training session for three sessions per week for eight weeks. The control group will also perform a warm-up except for FIFA 11+ and small-field play during these eight weeks.
Main outcome variables
The main outcome variables included isokinetic strength as primary and dynamic balance as secondary.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20250715066497N1
Registration date: 2025-07-20, 1404/04/29
Registration timing: prospective

Last update: 2025-07-20, 1404/04/29
Update count: 0
Registration date
2025-07-20, 1404/04/29
Registrant information
Name
seyed hossein seyed yaghoobzade harati
Name of organization / entity
Shahid beheshti
Country
Iran (Islamic Republic of)
Phone
+98 51 3742 6959
Email address
seyedyaghoobzadeharati@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2025-07-26, 1404/05/04
Expected recruitment end date
2025-09-18, 1404/06/27
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the Effects of 8 Weeks of FIFA 11+ and Small-Sided Games on Knee Isokinetic Strength and Dynamic Balance in Professional Football Players
Public title
Comparing the effects of two soccer warm-up programs on strength and balance factors
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
At least 3 years of experience in sports activity in football No previous severe injury within the past 6 months No history of lower limb surgery within the past year Voluntary consent of the subjects to participate in the study
Exclusion criteria:
People who are under 18 and over 21 years old. People whose football sports experience does not exceed 3 years. People who participated in preventive research within the past six months. People who have abnormalities or movement disorders in their lower limbs.
Age
From 18 years old to 21 years old
Gender
Male
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, cluster randomization was used, meaning that the random assignment unit was not individuals, but “soccer teams” as clusters. After calling 20 professional football teams in Tehran, 3 teams announced their willingness to participate in the study. For randomization, the names of the three teams were written separately on pieces of paper and placed in a box. Then, without prior knowledge of the contents of the papers, an independent person (not involved in the research) assigned the first name to the FIFA 11+ group, the second to the small-field group (SSG), and the third to the control group, respectively. This method was designed to maintain the natural structure of team training, reduce contamination between intervention groups, and facilitate the implementation of interventions in real team training conditions.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Shahid Beheshti University
Street address
ولنجک
City
Tehran
Province
Tehran
Postal code
1983969411
Approval date
2025-06-28, 1404/04/07
Ethics committee reference number
IR.SBU.REC.1404.084

Health conditions studied

1

Description of health condition studied
Sports injury prevention
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Isokinetic strength
Timepoint
At the beginning of the study and 8 weeks after the study
Method of measurement
Biodex dynamometer device

Secondary outcomes

1

Description
Balance
Timepoint
At the beginning of the study and 8 weeks after the intervention
Method of measurement
Biodex balance device

Intervention groups

1

Description
Individuals in the FIFA 11+ group complete the comprehensive FIFA 11+ warm-up program three sessions per week for eight weeks before their main training session to warm up.
Category
Prevention

2

Description
Control group: Control group: The control group will perform warm-ups during these eight weeks, except for FIFA 11+ and playing on small fields.
Category
Prevention

3

Description
Intervention group: Individuals in the small-pitch group also completed a small-pitch-based warm-up program before their main training session, three sessions per week for eight weeks.
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
Ariaspaco football team
Full name of responsible person
Bahadur Moradi
Street address
Seyed Khandan - Payam Sports Complex
City
Tehran
Province
Tehran
Postal code
1631713611
Phone
+98 21 4234 0000
Email
info@payamclub.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shahid Beheshti University
Full name of responsible person
Mehdi Gheitasi
Street address
Velenjak
City
Tehran
Province
Tehran
Postal code
1983969411
Phone
+98 912 354 7613
Email
mehdi.ghitasi@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti University
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
Shahid Beheshti University
Full name of responsible person
Seyed Hossein Seyed Yaqoobzadeh Herati
Position
Master student
Latest degree
Bachelor
Other areas of specialty/work
Sport Medicine
Street address
evin
City
Tehran
Province
Tehran
Postal code
1983969411
Phone
+98 915 208 8048
Email
seyedyaghoobzadeharati@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahid Beheshti University
Full name of responsible person
Syyed Hossein Seyed Yaqoobzadeh Herati
Position
Master student
Latest degree
Bachelor
Other areas of specialty/work
Sport Medicine
Street address
Evin
City
Tehran
Province
Tehran
Postal code
1983969411
Phone
+98 915 208 8048
Email
seyedyaghoobzadeharati@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Shahid Beheshti University
Full name of responsible person
Seyed Hossein Seyed Yaqoobzadeh Herati
Position
Master student
Latest degree
Bachelor
Other areas of specialty/work
Sport Medicine
Street address
Evin
City
Tehran
Province
Tehran
Postal code
1983969411
Phone
+98 915 208 8048
Email
seyedyaghoobzadeharati@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
Not applicable
Title and more details about the data/document
All data is potentially shared after de-identifying individuals.
When the data will become available and for how long
After printing the results
To whom data/document is available
Researchers working in academic and scientific institutions and people working in the sports industry
Under which criteria data/document could be used
No special conditions are considered.
From where data/document is obtainable
Seyed Hossein Seyed Yaqoobzadeh Herati seyedyaghoobzadeharati@gmail.com
What processes are involved for a request to access data/document
Email it and it will be sent as soon as possible.
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