effect of an eight-week Football Plus program on muscle strength and dynamic balance in young amateur male players.
Design
This Phase 0 randomized controlled clinical trial involves factorial groups with single-blinding. It includes 31 male football players under the age of 18. Simple randomization was conducted using the RAND function in Microsoft Excel.
Settings and conduct
The intervention group performs the Football Plus warm-up twice per week for 8 weeks, while the control group follows a routine of regular exercises. The Football Plus program consists of three intensity levels and lasts 20 to 22 minutes per session.
Participants/Inclusion and exclusion criteria
Male football players under 18 years old, currently active in Tehran's Division Two League, with no existing injuries. Exclusion Criteria: Missing two intervention sessions, concurrent participation in other sports, or absence from any measurement session
Intervention groups
intervention is the "Football Plus" program. These warm-up exercises are performed twice weekly for 8 weeks, starting from the 4th week of pre-season until the 6th week of competition.
Main outcome variables
Improvement in the strength of knee flexors and extensors, as well as enhancement of dynamic balance.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20240306061185N5
Registration date:2025-07-22, 1404/04/31
Registration timing:prospective
Last update:2025-07-22, 1404/04/31
Update count:0
Registration date
2025-07-22, 1404/04/31
Registrant information
Name
Hossein Rezaei
Name of organization / entity
The University of Shahid Beheshti
Country
Iran (Islamic Republic of)
Phone
+98 24 3562 3177
Email address
hosse.rezaei@mail.sbu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2025-07-27, 1404/05/05
Expected recruitment end date
2025-08-01, 1404/05/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Eight weeks application of the Football+ program (level one) improves muscle strength and dynamic balance in youth amateur male players.
Public title
effect of the Football Plus program on muscle strength and dynamic balance
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
U18 male players
competing in Division Two of the Tehran Football League
No previous injury
Exclusion criteria:
missing two or more intervention sessions
concurrent participation in other organized sports
absence from any measurement session
history of severe lower extremity injury 6 weeks before the baseline assessment
musculoskeletal surgery, head concussion severe cardiovascular problems six months before the study.
Age
From 16 years old to 18 years old
Gender
Male
Phase
N/A
Groups that have been masked
Investigator
Sample size
Target sample size:
31
Randomization (investigator's opinion)
Randomized
Randomization description
Coincidence tools: rand function of Excel:Individual simple randomization
Blinding (investigator's opinion)
Single blinded
Blinding description
A blinded research assistant delivered regular follow-up information and feedback to the Football+ group during the intervention phase, recognizing that adherence beyond mere participation and compliance is crucial to IPP success
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committee of Shahid Beheshti University
Street address
Building No. 2, University Headquarters-Shahid Beheshti University of Medical Sciences and Health Services -Arabi Street-Yemen Street -- Shahid Chamran Highway -Tehran
City
Tehran
Province
Tehran
Postal code
1983969411
Approval date
2025-07-20, 1404/04/29
Ethics committee reference number
IR.SBU.REC.1404.086
Health conditions studied
1
Description of health condition studied
Muscular strength and dynamic balance
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Assessment of concentric and eccentric strength of knee flexors and extensors
Timepoint
Before the intervention and eight weeks later
Method of measurement
Isokinetic dynamometry
2
Description
Dynamic balance test
Timepoint
Before the intervention and eight weeks later
Method of measurement
Biodex Balance System
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Football Plus
Category
Prevention
2
Description
Control group: Control
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Sports Science Laboratory, Shahid Beheshti University
Full name of responsible person
Sirus Sheikhi
Street address
Shahid Beheshti University, Shahriari Square , Velenjak, Tehran
City
Tehran
Province
Tehran
Postal code
1983969411
Phone
+98 21 2243 1953
Email
hosse.rezaei@mail.sbu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
The University of Shahid Beheshti
Full name of responsible person
dr. Mostafa Zarei
Street address
Shahid Beheshti University, Shahriari square, Volanjek Town, Tehran
City
Tehran
Province
Tehran
Postal code
1983969411
Phone
+98 21 2243 1953
Email
hosse.rezaei@mail.sbu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
The University of Shahid Beheshti
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
The University of Shahid Beheshti
Full name of responsible person
Hossein Rezaei
Position
Masters student
Latest degree
Bachelor
Other areas of specialty/work
Sports Injury and corrective exercises
Street address
No 403., Nawab Safavi Ave., Imam Hossein Square., Sain Qala
City
Sain Qala
Province
Zanjan
Postal code
4574148543
Phone
0098245623177
Email
hosse.rezaei@mail.sbu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
The University of Shahid Beheshti
Full name of responsible person
Hossein Rezaei
Position
Masters student
Latest degree
Bachelor
Other areas of specialty/work
Sports Injury and corrective exercises
Street address
No 403., Nawab Safavi Ave., Imam Hossein Square., Sain Qala
City
Sain Qala
Province
Zanjan
Postal code
4574148543
Phone
0098245623177
Email
hosse.rezaei@mail.sbu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
The University of Shahid Beheshti
Full name of responsible person
Hossein Rezaei
Position
Masters student
Latest degree
Bachelor
Other areas of specialty/work
Sports Injury and corrective exercise
Street address
No 403., Nawab Safavi Ave., Imam Hossein Square., Sain Qala
City
Sain Qala
Province
Zanjan
Postal code
4574148543
Phone
0098245623177
Email
hosse.rezaei@mail.sbu.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available