NCT03683758

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
21

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 6, 2018

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

September 10, 2018

Completed
15 days until next milestone

First Posted

Study publicly available on registry

September 25, 2018

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 11, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 11, 2018

Completed
10 months until next milestone

Results Posted

Study results publicly available

September 6, 2019

Completed
Last Updated

September 6, 2019

Status Verified

July 1, 2019

Enrollment Period

2 months

First QC Date

September 10, 2018

Results QC Date

April 28, 2019

Last Update Submit

July 30, 2019

Conditions

Keywords

footballsoccerwarm-upFIFA11+performancespeedagilityjump

Outcome Measures

Primary Outcomes (3)

  • 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

  • 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.

  • 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 Outcomes (1)

  • Warm-up Attendance

    8 weeks

Other Outcomes (1)

  • Player Information

    5 minutes before pre-testing.

Study Arms (2)

FIFA11+ / Intervention Group

EXPERIMENTAL

This group will complete the FIFA11+ warm-up three times per week for eight weeks.

Other: FIFA11+

Typical Warm-up / Control Group

ACTIVE COMPARATOR

This group will complete their usual warm-up three times per week for eight weeks

Other: 'Usual' Soccer Warm-up

Interventions

FIFA11+OTHER

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.

FIFA11+ / Intervention Group

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.

Typical Warm-up / Control Group

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Windsor Bubble

North Vancouver, Canada

Location

Related Publications (3)

  • 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.

    PMID: 24149156BACKGROUND
  • 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.

    PMID: 23855764BACKGROUND
  • Ayala F, Pomares-Noguera C, Robles-Palazon FJ, Del Pilar Garcia-Vaquero M, Ruiz-Perez I, Hernandez-Sanchez 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.

    PMID: 28192831BACKGROUND

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Limitations and Caveats

This pilot study was under-powered. Time and resources allowed for only two testing sessions which limited participant availability. With additional testing sessions, more players likely could attend participated in the study.

Results Point of Contact

Title
Dr. Matthew Wentzell
Organization
Mountain Health and Performance

Study Officials

  • Matthew N Wentzell, DC

    University of British Columbia Masters Student

    STUDY DIRECTOR
  • Cheryl Beach, PhD

    University of British Columbia Faculty of Medicine

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Participants from both teams will be aware of whether or not they received the intervention warm-up since the intervention warm-up would be a deviation from what each team typically performs for a warm-up. Investigator, Dr. Matt Wentzell is not blinded to which group is receiving the intervention warm-up since he will be leading the warm-up over the 8-week period. The three trained assistants will be performing the performance pre- and posttesting. They will be blinded to the group each player has been allocated to. Any study member that is not blinded will not be performing the pre- and posttesting.
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: A parallel, two-group, pre-post comparative trial is proposed for this study. Two soccer teams comprise the convenience sample. One team ("Impact") will be allocated to the control group while the other team ("Hearts") are allocated to the intervention group. Participant allocation is premeditated due to Dr. Matt Wentzell's regular paramedical involvement with the "Hearts" and therefore his ability to oversee and administer the intervention warm-up. The control warm-up will be run by the coaching staff of the control group. Performance pre-testing will be performed by three trained assistants one week after the 2018/2019 soccer season begins. Tests will be performed three times with the best test score being recorded. Both groups will then complete their assigned warm-up three times per week for eight weeks. Both groups will complete posttesting within three days of the trial period concluding in a fashion identical to that of the pre-testing session.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Adjunct Professor

Study Record Dates

First Submitted

September 10, 2018

First Posted

September 25, 2018

Study Start

September 6, 2018

Primary Completion

November 11, 2018

Study Completion

November 11, 2018

Last Updated

September 6, 2019

Results First Posted

September 6, 2019

Record last verified: 2019-07

Data Sharing

IPD Sharing
Will not share

Locations