Protocol summary

Study aim
The goals of physical therapy in the field of sports are to improve performance and prevent injury. Choosing the most efficient training program to prevent injury is essential. By identifying the immediate and short-term effects of TMR and FIFA 11+ and comparing their effects on dynamic balance, fast running, jumping, agility and knee valgus angle, the physiotherapist can take an important step in choosing an effective preparation program to achieve the goals of physiotherapy.
Design
A controlled, single-blind, randomized clinical trial on 45 participants
Settings and conduct
All testing procedures are done on the football field. First, one's group is determined by randomly picking one of 3 sealed envelopes containing one of the words "1st" (FIFA 11+), "2nd" (TMR) and "3rd" (Control). Participants will not know about the grouping of the study .
Participants/Inclusion and exclusion criteria
inclusion: 1. No history of musculoskeletal injury in the last 6 months in the lower limbs and back 2. Male football athletes between the ages of 17 and 23 3. At least one year of football experience 4. Absence of pain in the lower limbs and back Exclusion: 1. participant's unwillingness to continue the research process
Intervention groups
-(FIFA 11+): The FIFA 11+ program consists of three parts, starting with running exercises and continuing with 6 exercises to improve strength, balance, muscle control and core stability, and ending with advanced running exercises. it takes about 20 to 25 minutes. -(TMR): TMR is a new preparation program that is patient-related and its goal is immediate improvement in the quantity and quality of sports activities. The TMR protocol is bilateral and includes 6 movements. -(control): the control group will not receive any intervention.
Main outcome variables
dynamic blance, sprint, vertical jump, agility, knee valgus

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20240616062147N1
Registration date: 2024-06-22, 1403/04/02
Registration timing: registered_while_recruiting

Last update: 2024-06-22, 1403/04/02
Update count: 0
Registration date
2024-06-22, 1403/04/02
Registrant information
Name
Mostafa Barati
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2226 2165
Email address
mbarati@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-06-21, 1403/04/01
Expected recruitment end date
2024-08-20, 1403/05/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the acute and short-term effects of FIFA 11+ and total motion release warm-up programs on dynamic balance and physical performance in male football players
Public title
Comparing the acute and short-term effects of FIFA 11+ and total motion release warm-up programs on dynamic balance and physical performance in male football players
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Male football players between the ages of 17 and 23 No history of musculoskeletal injury in the last 6 months in the lower limbs and back At least one year of football experience Absence of pain in the lower limbs and back Absence of neurological diseases that affect performance
Exclusion criteria:
participant's unwillingness to continue the research process Taking drugs affecting balance
Age
From 17 years old to 23 years old
Gender
Male
Phase
N/A
Groups that have been masked
  • Participant
Sample size
Target sample size: 45
Randomization (investigator's opinion)
Randomized
Randomization description
Sampling will be done in an improbably and convenience sampling from football athletes aged 17 to 23 working in sports clubs in Tehran. In this way, the individual's group is determined by randomly picking one of 3 sealed envelopes containing one of the terms "first" (FIFA 11+), "second" (TMR) and "third" (control), and the participants from the grouping Study will not know.
Blinding (investigator's opinion)
Single blinded
Blinding description
In this study, the participants will not know about the grouping of the study. the individual's group is determined by randomly picking one of 3 sealed envelopes containing one of the terms "first" (FIFA 11+), "second" (TMR) and "third" (control), and the participants do not know what intervention they will receive.
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 research ethics committe
Street address
Keshavarz Boulevard, qods ave
City
tehran
Province
Tehran
Postal code
ندارد
Approval date
2024-05-07, 1403/02/18
Ethics committee reference number
IR.TUMS.FNM.REC.1403.032

Health conditions studied

1

Description of health condition studied
Injury prevention in football players
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
dynamic balance
Timepoint
baseline, after intervention, 2 hours after intervention
Method of measurement
y balance test

2

Description
vertical jump
Timepoint
baseline, after intervention, 2 hours after intervention
Method of measurement
counter movement jump

3

Description
knee valgus
Timepoint
baseline, after intervention, 2 hours after intervention
Method of measurement
knee valgus in landing

4

Description
agility
Timepoint
baseline, after intervention, 2 hours after intervention
Method of measurement
تست چابکی illinois

5

Description
sprint 20-m
Timepoint
baseline, after intervention, 2 hours after intervention
Method of measurement
20-m sprint test

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group1: (FIFA 11+ warm-up) This group performs the FIFA 11+ preparation program, which consists of three stages and lasts 20 minutes.
Category
Other

2

Description
Intervention group2: (total motion release warm-up) This group performs total motion release warm-up program that includes 6 bilateral movements and lasts 20 minutes.
Category
Other

3

Description
Control group: no intervention
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
تیم فوتبال آکادمی کیا (FC KIA)
Full name of responsible person
Coach: hadi mahdavi kia
Street address
besat highway- besat sports complex
City
tehran
Province
Tehran
Postal code
ندارد
Phone
+98 912 132 7474
Email
mostafa77.barati@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
dr khadije otadi
Street address
Tehran, District 12, Enghelab St، Pich-e-Shemiran
City
tehran
Province
Tehran
Postal code
1148965111
Phone
+98 21 7753 3939
Email
rehabilitation@tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran University of Medical Sciences
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
Tehran University of Medical Sciences
Full name of responsible person
Mostafa Barati
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
Takharestan ave, zafar ave, shariati ave
City
Tehran
Province
Tehran
Postal code
1918663373
Phone
+98 21 2226 2165
Fax
Email
Mbarati@razi.tums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
khadije otadi
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Tehran, District 12, Enghelab St، Pich-e-Shemiran
City
tehran
Province
Tehran
Postal code
1148965111
Phone
+98 21 7753 3939
Email
K_otadi@sina.tums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mostafa Barati
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
Takharestan ave, zafar ave, shariati ave
City
Tehran
Province
Tehran
Postal code
1918663373
Phone
+98 21 2226 2165
Fax
Email
Mbarati@razi.tums.ac.ir

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
Yes - There is a plan to make this available
Title and more details about the data/document
Part of the data, such as the main outcome information, will be shareable
When the data will become available and for how long
Access starts 6 months after the results are published
To whom data/document is available
Researchers working in academic and scientific institutions
Under which criteria data/document could be used
The data is not provided to the person for analysis and is only provided to the person for processes such as determining the sample size, etc.
From where data/document is obtainable
Thesis author: Mostafa Barati mostafa77.barati@gmail.com
What processes are involved for a request to access data/document
After sending an email to the author of the article, if the information is approved, it will be available to him after one week
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