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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03683758
Other study ID # H18-00383
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 6, 2018
Est. completion date November 11, 2018

Study information

Verified date July 2019
Source University of British Columbia
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study is being conducted for a master's dissertation. Our goal is to determine if there are physical performance benefits to performing the FIFA11+ soccer warm-up program in adult female soccer players over an eight week period. This topic has been studied primarily using male soccer players. The performance effects in adult female soccer players is currently unknown.

This warm-up has been shown to reduce non-contact injury rates in soccer players aged >13. If performance benefits are demonstrated in this study, in addition to the reported injury reduction benefits of the FIFA11+ warm-up, program adherence and player performance could improve.


Recruitment information / eligibility

Status Completed
Enrollment 21
Est. completion date November 11, 2018
Est. primary completion date November 11, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 45 Years
Eligibility Inclusion Criteria:

- Must be a female amateur soccer players on a North Shore Girls Soccer Club Selects A Team

- Must be between the ages of 18 and 45

- Must play a forward, midfield or defender position

Exclusion Criteria:

- Mustn't play a goal keeper position. The physical demands of this position is drastically different than all other soccer positions. The training effects from practices and games are unique and may therefore influence the effects the FIFA11+ has on players of this particular positions.

- Mustn't have an illness or injury preventing them from participating in soccer practice, games, and testing procedures. Injury or illness would likely result in poorer physical performance outcomes relative to healthy participants.

- Mustn't miss a physical performance testing session. Pre- and posttest data is required to determine if there are changes in performance metrics in relation to both the intervention and control groups.

- Mustn't be pregnant or of childbearing potential for the duration of the study (10 weeks). The PI and Co-Investigators are not familiar with each participant's reproductive health and history or how pregnancy may affect each participant's response to either the intervention or control group. It is therefore decided that participants that are pregnant or of childbearing potential will be removed from the study.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
FIFA11+
The FIFA11+ has three parts and consist of 15 exercises. Part 1 consists of active stretching, running and controlled partner contact drills. Part 2 has three difficulty levels for 6 sets of exercises. The exercises consist of core and leg strength exercises, balance and plyometric drills. The exercises in this section are perhaps the most unique element to the FIFA11+ warm-up, as strength-specific exercises like the Nordic Hamstring Curl are not generally included in soccer warm-ups. Part 3 consists of higher intensity running drills, compared to those covered in Part 1. Unlike many soccer warm-ups, the FIFA11+ has been studied rigorously in terms of its injury reduction potential.
'Usual' Soccer Warm-up
This warm-up is time-matched to the FIFA11+ (approximately 20 minutes) and is considered 'usual' for the team. This warm-up consists of stretching, running and agility drills, in addition to "small sided" games with a soccer ball, which is not a part of the FIFA11+. The 'usual' warm-up is decided by the coach with no standardization nor any formal research on its effectiveness in injury reduction or performance enhancement.

Locations

Country Name City State
Canada Windsor Bubble North Vancouver

Sponsors (2)

Lead Sponsor Collaborator
University of British Columbia North Shore Girls Soccer Club

Country where clinical trial is conducted

Canada, 

References & Publications (3)

Ayala F, Pomares-Noguera C, Robles-Palazón FJ, Del Pilar García-Vaquero M, Ruiz-Pérez I, Hernández-Sánchez S, De Ste Croix M. Training Effects of the FIFA 11+ and Harmoknee on Several Neuromuscular Parameters of Physical Performance Measures. Int J Sports Med. 2017 Apr;38(4):278-289. doi: 10.1055/s-0042-121260. Epub 2017 Feb 13. — View Citation

Daneshjoo A, Mokhtar AH, Rahnama N, Yusof A. Effects of the 11+ and Harmoknee Warm-up Programs on Physical Performance Measures in Professional Soccer Players. J Sports Sci Med. 2013 Sep 1;12(3):489-96. eCollection 2013. — View Citation

Impellizzeri FM, Bizzini M, Dvorak J, Pellegrini B, Schena F, Junge A. Physiological and performance responses to the FIFA 11+ (part 2): a randomised controlled trial on the training effects. J Sports Sci. 2013;31(13):1491-502. doi: 10.1080/02640414.2013.802926. Epub 2013 Jul 16. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Other Player Information Month and year of birth, height, weight and player position, number of years playing soccer, injury status, approximate number of hours of moderate/high intensity exercise per week (including soccer), and pregnancy status will be collected from each player.
This information will be collected to compare and contrast the averages of these variables once participants are assigned to the control or intervention group.
5 minutes before pre-testing.
Primary Percentage Change From Baseline in 10m Sprint Times After an 8 Week Intervention 10m sprint times will be recorded in seconds.
The 10m sprint involves a stationary participant starting behind a timing gate and running through a second timing gate 10 meters away.
Three trials will be performed during the pre-test and the posttest, with the best time being selected for each. Participants will have a 2-minute break between trials.
Intervention is 8 weeks in duration with baseline and post-test outcome measurements occurring within 3 days of the commencement and end of the intervention period
Primary Percentage Change From Baseline in Agility T-Test Times After an 8 Week Intervention Agility T-test times will be recorded in seconds..
The Agility T-Test involves a stationary participant running forward through a timing gate to touch a cone 10 yards away, shuffle 5 yards to the left to touch a second cone, shuffle right 10 yards to touch a third cone, shuffle left to touch a fourth cone (the first cone touched after the 10 yard run), then back-peddle 10 yards to pass through the timing gate a second time. This running pattern creates a "T" shape with the vertical and horizontal components of the "T" measuring 10 yards each.
Three trials will be performed during the pre-test and the posttest, with the best time being selected for each. Participants will have a 2-minute break between trials.
Intervention is 8 weeks in duration with baseline and post-test outcome measurements occurring within 3 days of the commencement and end of the intervention period.
Primary Percentage Change From Baseline in Squat Jump Height After an 8 Week Intervention Squat jumps will be measured in centimeters.
This test requires each participant to stand on a contact mat with their hands on their hips, squat and pause in a position with their knees at a 90 degree angle, then propel upward as high as possible.
Three trials will be performed during the pre-test and the posttest, with the best time being selected for each. Participants will have a 1-minute break between trials.
Intervention is 8 weeks in duration with baseline and post-test outcome measurements occurring within 3 days of the commencement and end of the intervention period
Secondary Warm-up Attendance Practice and game attendance will be recorded so warm-up compliance may be calculated. This will be done three days per week for eight weeks. 8 weeks
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