Protocol summary

Study aim
To assess the efficacy of the “11+ Kids” warm-up programme regarding injury reduction in high-level children’s football players.
Design
a two-armed cluster-randomized controlled trial, The observation period comprised one football season (9 months) from February 2017 to November 2017. the intervention group was to use the new injury prevention programme (“11+ Kids”) as a warm-up, while the control clubs used their regular warm-up programme.
Settings and conduct
All high-level football schools from five provinces of Iran were randomly allocated to an intervention group and a control group. An automated randomization procedure was conducted by a researcher who had no direct contact with the clubs or team officials and who was not involved in the intervention.
Participants/Inclusion and exclusion criteria
1.teams are competing in the highest league of their province; 2.players are between 7 and 14 years old at the start of the study, and 3.regular training must take place at least twice per week. 4. Teams were excluded from the study if they already used an exercise-based injury prevention measure.
Intervention groups
INT replaced their warm-up by “11+ Kids”. The “11+ Kids” programme consists of seven exercises and takes about 15 to 20 min to be performed. the intervention group was asked to use the “11+ Kids” programme at least twice a week at the beginning of the training session, replacing their usual warm-up. The coaches of the control group were asked to use their usual warm-up routine.
Main outcome variables
incidence of lower extremities injuries

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20180526039850N1
Registration date: 2019-02-03, 1397/11/14
Registration timing: prospective

Last update: 2019-02-03, 1397/11/14
Update count: 0
Registration date
2019-02-03, 1397/11/14
Registrant information
Name
Hamed Abbasi
Name of organization / entity
Sports Sciences Research Institute of Iran (SSRII)
Country
Iran (Islamic Republic of)
Phone
+98 21 8874 7884
Email address
h.abbasi@ssrc.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-02-02, 1397/11/13
Expected recruitment end date
2019-11-01, 1398/08/10
Actual recruitment start date
2019-02-11, 1397/11/22
Actual recruitment end date
2019-11-15, 1398/08/24
Trial completion date
2019-12-01, 1398/09/10
Scientific title
The “11+ Kids” warm-up programme to prevent injuries in young high-level football players: a cluster randomized controlled trial
Public title
Investigating the Effect of the 11+ Program on Prevention of Injuries in Football Players
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
teams are competing in the highest league of their province players are between 7 and 14 years old at the start of the study regular training must take place at least twice per week
Exclusion criteria:
If the teams already used an exercise-based injury prevention measure
Age
From 7 years old to 14 years old
Gender
Male
Phase
N/A
Groups that have been masked
  • Investigator
Sample size
Target sample size: 1250
Actual sample size reached: 962
Randomization (investigator's opinion)
Randomized
Randomization description
all high-level football schools from five provinces of Iran were invited to participate in the study. Participating clubs were randomly allocated to an intervention group and a control group. All teams of the same club were allocated to the same group to minimize the risk of contamination. An automated randomization procedure was conducted by a researcher who had no direct contact with the clubs or team officials and who was not involved in the intervention. The number of participating teams per club and the age group served as strata for the randomization.
Blinding (investigator's opinion)
Single blinded
Blinding description
by a researcher who had no direct contact with the clubs or team officials and who was not involved in the intervention.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Sports Sciences Research Institute
Street address
No. 3, 5th Alley, Miremad Street, Motahhari Street, Tehran, Iran.
City
Tehran
Province
Tehran
Postal code
1587958711
Approval date
2019-01-23, 1397/11/03
Ethics committee reference number
IR.SSRC.REC.1397.001

Health conditions studied

1

Description of health condition studied
Dislocation, sprain and strain of joints and ligaments of knee
ICD-10 code
S80
ICD-10 code description
Superficial injury of knee and lower leg

2

Description of health condition studied
Superficial injury of ankle and foot
ICD-10 code
S90
ICD-10 code description
Superficial injury of ankle, foot and toes

3

Description of health condition studied
Superficial injury of hip and thigh
ICD-10 code
S70
ICD-10 code description
Superficial injury of hip and thigh

Primary outcomes

1

Description
football related lower extremity injuries
Timepoint
Through one football season
Method of measurement
Reporting

Secondary outcomes

1

Description
Knee injuries Ankle injuries,
Timepoint
36 weeks
Method of measurement
Sport Injuries Registration Form

Intervention groups

1

Description
Intervention group: used the new injury prevention programme (“11+ Kids”) as a warm-up during the season
Category
Prevention

2

Description
Control group: used routine warm-up programme during the season
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
Sports Medicine Center of the National Iranian Football Academy
Full name of responsible person
Tohid Seif Barghi
Street address
After the Olympic Hotel, West Blvd. Azadi Stadium,Tehran
City
Tehran
Province
Tehran
Postal code
1484813111
Phone
+98 21 4473 8641
Email
tohid_seif@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Research Deputy of Sports Sciences Research Institute, Sports Sciences Research Institute
Full name of responsible person
Dr Ali Kashi
Street address
No. 3, 5th Alley, Miremad Street, Motahhari Street, Tehran, Iran.
City
Tehran
Province
Tehran
Postal code
1587958711
Phone
+98 21 8852 9121
Email
Ssrc.intoffice@gmail.com
Web page address
http://ssrc.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Research Deputy of Sports Sciences Research Institute, Sports Sciences Research Institute
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
Sports Sciences Research Institute
Full name of responsible person
Hamed Abbasi
Position
Assitant professor
Latest degree
Ph.D.
Other areas of specialty/work
Sport Medicine
Street address
No. 3, 5th Alley, Miremad Street, Motahhari Street, Tehran, Iran.
City
Tehran
Province
Tehran
Postal code
1587958711
Phone
+98 21 8852 9121
Email
h.abbasi@ssrc.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Sports Sciences Research Institute
Full name of responsible person
Hamed abbasi
Position
Assitant professor
Latest degree
Ph.D.
Other areas of specialty/work
Sport Medicine
Street address
No. 3, 5th Alley, Miremad Street, Motahhari Street, Tehran, Iran.
City
Tehran
Province
Tehran
Postal code
1587958711
Phone
+98 21 8852 9121
Fax
+98 21 8875 0884
Email
h.abbasi@ssrc.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Sports Sciences Research Institute
Full name of responsible person
Hamed Abbasi
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Sport Medicine
Street address
No. 3, 5th Alley, Miremad Street, Motahhari Street, Tehran, Iran.
City
Tehran
Province
Tehran
Postal code
1587958711
Phone
+98 2188909509454
Fax
Email
h.abbasi@ssrc.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
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
Data relating to the control and intervention group in the pre and post test groups will be shared as unidentified.
When the data will become available and for how long
Six months after the publication of the articles
To whom data/document is available
All the researchers
Under which criteria data/document could be used
data is allowed to use in case of citing the reference
From where data/document is obtainable
hamed abbasi
What processes are involved for a request to access data/document
by an email
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