SoccerFIFANCT03683758

Effects of the FIFA11+ Warm-up Program on Speed, Agility, and Vertical Jump Performance in Adult Female Amateur Soccer Players

A study testing FIFA11+ and 'Usual' Soccer Warm-up in people with Soccer and Exercise, run by University of British Columbia at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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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. Read more about this study

Who is it for?: Ages 18 to 45 years, women onlyHealthy volunteers can take part
Conditions the study is for: Soccer, Exercise, Athletic Performance
What is being tested?: FIFA11+ and 'Usual' Soccer Warm-up
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 21 participants
Where: 1 siteCanada
Study dates: 6 Sep 2018to 11 Nov 2018
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 45 years
Women only
Healthy volunteers accepted
Adult

Who may be able to join

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

Who cannot join

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.

Trial locations and contacts

1 site in 1 country.

Canada1 site

Windsor Bubble
North Vancouver

Other trials in Canada

About this study

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.

Conditions: Soccer, Exercise, Athletic Performance
Being tested: FIFA11+, 'Usual' Soccer Warm-up
Keywords: football, soccer, warm-up, FIFA, 11+, performance, speed, agility, jump
Medical subject headings: Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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.
'Usual' Soccer Warm-upOther
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.

Study groups in NCT03683758
Study group	Role	What they receive
FIFA11+ / Intervention Group	Experimental	This group will complete the FIFA11+ warm-up three times per week for eight weeks. Receives: Other: FIFA11+
Typical Warm-up / Control Group	Active comparator	This group will complete their usual warm-up three times per week for eight weeks Receives: Other: 'Usual' Soccer Warm-up

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 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.
Measured: 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
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.
Measured: 8 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

6 Sep 201811 Nov 2018

First posted25 Sep 2018
Study start6 Sep 2018
Primary completion11 Nov 2018
Study completion11 Nov 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (3)Papers the sponsor has linked to this study.
Other trials for SoccerStudies of the same condition, open and under way.
More trials run by University of British ColumbiaThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Supportive care
Allocation: Non-randomised
Intervention model: Parallel groups
Model description: 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.
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 21 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03683758
Sponsor's protocol ID: H18-00383
Acronym: FIFA
Status last verified: Jul 2019
First submitted: 10 Sep 2018
Last updated: 6 Sep 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

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.
PubMed 24149156
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.
PubMed 23855764
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.
PubMed 28192831

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 6 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effects of the FIFA11+ Warm-up Program on Speed, Agility, and Vertical Jump Performance in Adult Female Amateur Soccer Players
ClinicalTrials.gov ID: NCT03683758
Acronym / sponsor ID: FIFA / H18-00383
Conditions: Soccer, Exercise, Athletic Performance
Keywords: football, soccer, warm-up, FIFA, 11+, performance, speed, agility
Study type: Interventional
Recruitment status: Completed
Enrolment: 21 participants (actual)
Lead sponsor: University of British ColumbiaUniversity, hospital or other
Collaborators: North Shore Girls Soccer Club
Study start: 6 Sep 2018 (actual)
Primary completion: 11 Nov 2018 (actual)
Study completion: 11 Nov 2018 (actual)
First posted: 25 Sep 2018 (actual)
Results: Posted 6 Sep 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Supportive care
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 2
Model description: 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.

Arm	Type	Receives
FIFA11+ / Intervention Group	Experimental	Other: FIFA11+This group will complete the FIFA11+ warm-up three times per week for eight weeks.
Typical Warm-up / Control Group	Active comparator	Other: 'Usual' Soccer Warm-upThis group will complete their usual warm-up three times per week for eight weeks

Who may qualify

Ages: 18 to 45 years
Sex: Female only
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (3 listed)

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

Key exclusion criteria (4 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
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.	Other	FIFA11+ / Intervention Group
'Usual' Soccer Warm-upThis 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.	Other	Typical Warm-up / Control Group

Primary outcome

Percentage Change From Baseline in 10m Sprint Times After an 8 Week Intervention
Time frame: 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
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.
Percentage Change From Baseline in Agility T-Test Times After an 8 Week Intervention
Time frame: 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.
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.
Percentage Change From Baseline in Squat Jump Height After an 8 Week Intervention
Time frame: 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
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.

1 secondary outcome

Warm-up Attendance
Time frame: 8 weeks

Results and safety

Results posted to the registry on 6 Sep 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
FIFA11+ / Intervention Group	11	8
Typical Warm-up / Control Group	10	7

Primary outcome: Percentage Change From Baseline in 10m Sprint Times After an 8 Week Intervention

Time frame: 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. Mean (Standard Deviation). Unit: Percentage of change

Measure	FIFA11+ / Intervention Group n = 8	Typical Warm-up / Control Group n = 7
Value	4.13 (5.85)	-1.08 (4.38)

Population analysed: Three players from each team were not included in the analysis due to breach of inclusion criteria (i.e. injury, illness and/or missing a testing session)

Primary outcome: Percentage Change From Baseline in Agility T-Test Times After an 8 Week Intervention

Time frame: 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.. Mean (Standard Deviation). Unit: Percentage of change

Measure	FIFA11+ / Intervention Group n = 8	Typical Warm-up / Control Group n = 7
Value	8.18 (2.35)	5.89 (2.12)

Population analysed: Three players from each team were not included in the analysis due to breach of inclusion criteria (i.e. injury, illness and/or missing a testing session)

Primary outcome: Percentage Change From Baseline in Squat Jump Height After an 8 Week Intervention

Measure	FIFA11+ / Intervention Group n = 8	Typical Warm-up / Control Group n = 7
Value	11.88 (6.9)	7.54 (7.1)

Population analysed: Three players from each team were not included in the analysis due to breach of inclusion criteria (i.e. injury, illness and/or missing a testing session)

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Adverse event data was collected from the pre-testing phase, through the 8 week intervention, up until the end of the post-testing phase for a total of 9 weeks (i.e. up to 3 days before and 3 days after the intervention period).. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
FIFA11+ / Intervention Group	1 of 11 (9.1%)	0 of 11 (0%)	0 of 11
Typical Warm-up / Control Group	0 of 10 (0%)	0 of 10 (0%)	0 of 10

Limitations and caveats (from the sponsor): 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.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 6 Sep 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 24149156Daneshjoo 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.
Background: PubMed 23855764Impellizzeri 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.
Background: PubMed 28192831Ayala 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.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Matthew N Wentzell, DC study director

University of British Columbia Masters Student

Cheryl Beach, PhD principal investigator

University of British Columbia Faculty of Medicine

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing FIFA11+ and 'Usual' Soccer Warm-up in people with Soccer and Exercise, run by University of British Columbia at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 6 Sep 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage Change From Baseline in 10m Sprint Times After an 8 Week Intervention (time frame: 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). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03683758, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Sep 2019.