Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03683758
Recruitment Status : Completed
First Posted : September 25, 2018
Results First Posted : September 6, 2019
Last Update Posted : September 6, 2019
Sponsor:
Collaborator:
North Shore Girls Soccer Club
Information provided by (Responsible Party):
Cheryl Beach, University of British Columbia

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Outcomes Assessor);   Primary Purpose: Supportive Care
Conditions Soccer
Exercise
Athletic Performance
Interventions Other: FIFA11+
Other: 'Usual' Soccer Warm-up
Enrollment 21
Recruitment Details Recruitment was performed through convenience sampling. Potential study participants are identified through Co-Investigator, Dr. Matt Wentzell's, prior involvement as the trainer/first aid respondent for one of the two NSGSC teams.
Pre-assignment Details

Participants allocation is premeditated by team-based on the MW's regular paramedical involvement with one of the teams and therefore his ability to oversee and administer the intervention warm-up.

Goaltenders, pregnancy, injury/illness preventing participation in performance testing, practices or games are all grounds for study exclusion.

Arm/Group Title FIFA11+ / Intervention Group Typical Warm-up / Control Group
Hide Arm/Group Description

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

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.

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

'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 included in 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.

Period Title: Overall Study
Started 11 10
Completed 8 7
Not Completed 3 3
Reason Not Completed
Non-study commitment conflict             1             3
Illness preventing participation             1             0
Adverse Event             1             0
Arm/Group Title FIFA11+ / Intervention Group Typical Warm-up / Control Group Total
Hide Arm/Group Description

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

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.

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

'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.

Total of all reporting groups
Overall Number of Baseline Participants 11 10 21
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 11 participants 10 participants 21 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
11
 100.0%
10
 100.0%
21
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 11 participants 10 participants 21 participants
28.1  (6.6) 27.1  (3.2) 27.6  (5.1)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 11 participants 10 participants 21 participants
Female
11
 100.0%
10
 100.0%
21
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
Race and Ethnicity Not Collected   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 0 participants 0 participants 0 participants
0
[1]
Measure Analysis Population Description: Race and Ethnicity were not collected from any participant.
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Canada Number Analyzed 11 participants 10 participants 21 participants
11 10 21
Height (cm)  
Mean (Standard Deviation)
Unit of measure:  Centimeters
Number Analyzed 11 participants 10 participants 21 participants
169.3  (5.4) 163.3  (5.6) 166.4  (6.2)
Weight (kg)  
Mean (Standard Deviation)
Unit of measure:  Kilograms
Number Analyzed 11 participants 10 participants 21 participants
62.7  (5.7) 60.2  (8.2) 61.5  (7.0)
Years of experience  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 11 participants 10 participants 21 participants
20.9  (6.3) 20.1  (1.8) 20.5  (4.6)
Moderate/high intensity activity per week (hours)  
Mean (Standard Deviation)
Unit of measure:  Hours
Number Analyzed 11 participants 10 participants 21 participants
7  (3.4) 6.9  (3.5) 7.0  (3.4)
1.Primary Outcome
Title Percentage Change From Baseline in 10m Sprint Times After an 8 Week Intervention
Hide Description

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.

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
Hide Outcome Measure Data
Hide Analysis Population Description
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)
Arm/Group Title FIFA11+ / Intervention Group Typical Warm-up / Control Group
Hide Arm/Group Description:

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

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.

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

'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 included in 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.

Overall Number of Participants Analyzed 8 7
Mean (Standard Deviation)
Unit of Measure: Percentage of change
4.13  (5.85) -1.08  (4.38)
2.Primary Outcome
Title Percentage Change From Baseline in Agility T-Test Times After an 8 Week Intervention
Hide Description

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.

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.
Hide Outcome Measure Data
Hide Analysis Population Description
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)
Arm/Group Title FIFA11+ / Intervention Group Typical Warm-up / Control Group
Hide Arm/Group Description:

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

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.

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

'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 included in 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.

Overall Number of Participants Analyzed 8 7
Mean (Standard Deviation)
Unit of Measure: Percentage of change
8.18  (2.35) 5.89  (2.12)
3.Primary Outcome
Title Percentage Change From Baseline in Squat Jump Height After an 8 Week Intervention
Hide Description

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.

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
Hide Outcome Measure Data
Hide Analysis Population Description
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)
Arm/Group Title FIFA11+ / Intervention Group Typical Warm-up / Control Group
Hide Arm/Group Description:

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

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.

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

'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 included in 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.

Overall Number of Participants Analyzed 8 7
Mean (Standard Deviation)
Unit of Measure: Percentage of change
11.88  (6.9) 7.54  (7.1)
4.Secondary Outcome
Title Warm-up Attendance
Hide Description 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.
Time Frame 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
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)
Arm/Group Title FIFA11+ / Intervention Group Typical Warm-up / Control Group
Hide Arm/Group Description:

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

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.

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

'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 included in 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.

Overall Number of Participants Analyzed 8 7
Mean (Standard Deviation)
Unit of Measure: Percentage of warm-ups attended
79.41  (0.09) 80.36  (0.16)
5.Other Pre-specified Outcome
Title Player Information
Hide Description

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.

Time Frame 5 minutes before pre-testing.
Outcome Measure Data Not Reported
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).
Adverse Event Reporting Description

Adverse event collection was performed for the intervention group via Co-Investigator's (MW) presence at all performance testing sessions and all practices and games over the eight week intervention period.

Adverse events collection for the control group was performed by monitoring participant attendance on a weekly basis. If three or more warm-ups were missed, Co-Investigator (MW) would follow up with the control group regarding the reason a player may not be in attendance.

 
Arm/Group Title FIFA11+ / Intervention Group Typical Warm-up / Control Group
Hide Arm/Group Description

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

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.

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

'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 included in 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.

All-Cause Mortality
FIFA11+ / Intervention Group Typical Warm-up / Control Group
Affected / at Risk (%) Affected / at Risk (%)
Total   0/11 (0.00%)      0/10 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
FIFA11+ / Intervention Group Typical Warm-up / Control Group
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/11 (9.09%)      0/10 (0.00%)    
Musculoskeletal and connective tissue disorders     
ACL Injury  [1]  1/11 (9.09%)  1 0/10 (0.00%)  0
Indicates events were collected by systematic assessment
[1]
An ACL tear was sustained by a participant in the FIFA11+ group. The ACL tear did not occur during the intervention warm-up. The participant sustained the injury during a game after returning from a 2-week vacation, voiding her study participation.
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
FIFA11+ / Intervention Group Typical Warm-up / Control Group
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/11 (0.00%)      0/10 (0.00%)    
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.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Matthew Wentzell
Organization: Mountain Health and Performance
Phone: 6043566986
EMail: drwentzell@mountainhp.ca
Layout table for additonal information
Responsible Party: Cheryl Beach, University of British Columbia
ClinicalTrials.gov Identifier: NCT03683758     History of Changes
Other Study ID Numbers: H18-00383
First Submitted: September 10, 2018
First Posted: September 25, 2018
Results First Submitted: April 28, 2019
Results First Posted: September 6, 2019
Last Update Posted: September 6, 2019