Injury PreventionNCT04958837
Effects of FIFA 11+ With Dynamic Core Stability Training on Balance and Dynamic Knee Valgus in Amateur Soccer Players
A study testing FIFA 11+ protocol with additional Core training exercises and FIFA 11+ protocol in people with Injury Prevention and Postural Balance, run by Riphah International University at 1 site in Pakistan.
Trial summary
The incidence of soccer-related injuries is reported to have the highest rate amongst all sports. To reduce the incidence of soccer injuries in youth and amateur soccer players, an injury prevention framework namely FIFA 11+ was established. Read more about this study
- Who is it for?
- Ages 13 to 25 yearsHealthy volunteers can take part
- Conditions the study is for
- Injury Prevention, Postural Balance
- What is being tested?
- FIFA 11+ protocol with additional Core training exercises and FIFA 11+ protocol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 sitePakistan
- Study dates
- 15 Jul 2021to 30 Jun 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 13 to 25 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Both males and females
- Between the Age of 13-25 Years
- Participants will be selectively recruited with high risk of ACL/Knee Injury.
- Individuals of selected football academies, performing routine exercise according to the football academy.
- Able to provide informed consent by them self or from guardians
Who cannot join
- Players having history of any Musculoskeletal Disorder or injury
- Players having recent injury resulting in at least 10-30 days off time from full training or matches.
- Players having history of skeletal trauma such as lower limb fractures.
- Players having history of any severe medical problems hindering regular participation in evaluation or training.
- Players using any nutritional supplements.
Trial locations and contacts
1 site in 1 country.
Pakistan1 site, 1 recruiting
- Recruiting
Foundaion University Institute of Rehabilitation Sciences
Islamabad, 44000
Furqan A Siddiqi, PhD, 0092515788151 ext. 602, furqan@fui.edu.pk
About this study
Official title: Effects of FIFA 11+ With and Without Dynamic Core Stability Training on Balance and Dynamic Knee Valgus in Amateur Soccer Players at Risk of Anterior Cruciate Ligament Injury
The incidence of soccer-related injuries is reported to have the highest rate amongst all sports. To reduce the incidence of soccer injuries in youth and amateur soccer players, an injury prevention framework namely FIFA 11+ was established. Although the FIFA 11+ is a comprehensive warm-up and training program for soccer players, yet in the second component focusing on strength and plyometric training, the exercises consist of only static core training whereas dynamic core training is not included in the protocol. Hence this study will observe the effect of including dynamic core training targeting the remaining core musculature as well in the FIFA 11 + program for risk factor modification and correction of muscular imbalance.
Read the detailed description
Soccer (football) is one of the most popular sports in the world. Intense soccer actions (i.e., acceleration, decelerations, change of direction, sprinting, tackling, running, being tackled, and shooting, twisting, turning, jumping and landing during the game) in addition to high impact and forceful body contacts during practice sessions and matches predispose the athletes to injuries. various contributing factors of these injuries include muscular imbalance, joint instability, lack of proper training and inadequate rehabilitation. Poor landing mechanics, specifically, increased dynamic knee valgus, is also associated with increased risk for lower limb injury, particularly ACL injury. The modifiable factors are shown to be responsive to different types of trainings. In fact neuromuscular factors are involved in control of dynamic knee stability, hamstrings and quadriceps imbalances, asymmetry of legs and core dysfunction. The latest FIFA 11+ developed in 2006 was designed to be used as pre-training protocol to improve the components of physical fitness that might contribute to injury prevention. In this program, there is a combination of three major exercise regime components: an initial running and stretching exercises, second component of strength, plyometric and balance exercises, ending with high speed planting and cutting exercises. One of the component of this program involves the training of core musculature. While the core muscles (including muscles of trunk and pelvis) do not cross the knee joint, yet core stability can modulate the lower limb alignment and loading during dynamic tasks. Hence, this study will be conducted to find whether there is any effect of including dynamic core training in the FIFA 11+ program in order to correct muscular imbalances and ultimately risk factor modification. A two-arm single blinded randomized controlled trial will be conducted to find out the dynamic knee valgus alignment, postural stability and single leg athletic stability and lower limb muscles strength, while the secondary outcomes would include lung function tests (FEV1, FVC \& FEV1/FVC ratio). In the control group, standard FIFA 11+Protocol will be followed consisting of slow paced running exercises followed by strength, plyometric and balance training. In the experimental group, FIFA 11+ protocol along with additional dynamic core exercises will be followed including leg raises, crunches, superman, plank hip twist, and supine bridge.All exercises in both groups will be progressively increased as per established protocol. Training will be provided 3-4 Times a week for 8 Weeks on alternate days.
- Conditions
- Injury Prevention, Postural Balance
- Being tested
- FIFA 11+ protocol with additional Core training exercises, FIFA 11+ protocol
- Keywords
- Exercise training, knee joint, soccer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FIFA 11+ protocol with additional Core training exercisesOther
Slow paced running exercises of 8 minutes' duration (2 rounds each), followed by Strength, plyometric and balance exercises including 3 sets of 20-30 sec of The Bench, Sideways Bench each side, Nordic Hamstring strengthening, single leg stance balance training, squatting and high speed running. The protocol will end with additional core training exercises including leg raises, crunches, superman, plank hip twist, and supine bridge. Each exercise plan will be progressively increased. Core training will be followed by 30 sec stretch of major muscle groups.
FIFA 11+ protocolOther
Slow paced running exercises of 8 minutes' duration including running straight, running with hip out, running hip in, running circling partner, running shoulder contact and running quickly forward and backwards (2 rounds each), followed by Strength, plyometric and balance exercises including The Bench, Sideways Bench each side, Nordic Hamstring strengthening and single leg stance balance training, squatting and jumping. All exercises will be progressively increased as per established protocol. The final phase of the study includes fast running for 2 minutes.
| Study group | Role | What they receive |
|---|---|---|
| FIFA 11+ with dynamic core stability training | Experimental | Participants in this group will undergo FIFA 11+ protocol along with additional Core training exercises including leg raises, crunches, superman, plank hip twist, and supine bridge will be given. Each exercise plan will be progressively increased. Receives: Other: FIFA 11+ protocol with additional Core training exercises |
| FIFA 11+ protocol | Active comparator | Participants in this group will undergo traditional FIFA 11+ protocol which consists of slow paced running exercises, strength, plyometric \& Balance exercises and high speed running with planting/cutting Receives: Other: FIFA 11+ protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dynamic Knee Valgus
Dynamic knee valgus will be measured using Motion Analysis System and expressed in form of degrees.
Measured: 8 weeks
Single Leg Athletic Stability
Single Leg Athletic Stability will be measured using objective balance evaluation system.
Measured: 8 weeks
Secondary outcomes (1)
Lung function Test
FEV1 \& FCV will be measured using hand held spirometer dynamometer and expressed in form Liters.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2021
- Study start15 Jul 2021
- Primary completion30 Jun 2022 (estimated)
- Study completion30 Jun 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Injury PreventionStudies of the same condition, open and under way.
- More trials run by Riphah International UniversityThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomly allocated to Interventional Group A (FIFA 11+ with dynamic core stability training protocol) or Interventional Group B/ Control Group (FIFA 11+ protocol) for the whole duration of the study.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Muhammad Salman Bashir, PhD, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04958837
- Sponsor's protocol ID
- REC/RCR & AHS/21/1105
- Status last verified
- May 2022
- First submitted
- 6 Jul 2021
- Last updated
- 2 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of FIFA 11+ With and Without Dynamic Core Stability Training on Balance and Dynamic Knee Valgus in Amateur Soccer Players at Risk of Anterior Cruciate Ligament Injury
- ClinicalTrials.gov ID
- NCT04958837
- Acronym / sponsor ID
- REC/RCR & AHS/21/1105
- Conditions
- Injury Prevention, Postural Balance
- Keywords
- Exercise training, knee joint, soccer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 15 Jul 2021 (actual)
- Primary completion
- 30 Jun 2022 (estimated)
- Study completion
- 30 Jun 2022 (estimated)
- First posted
- 12 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The incidence of soccer-related injuries is reported to have the highest rate amongst all sports. To reduce the incidence of soccer injuries in youth and amateur soccer players, an injury prevention framework namely FIFA 11+ was established. Although the FIFA 11+ is a comprehensive warm-up and training program for soccer players, yet in the second component focusing on strength and plyometric training, the exercises consist of only static core training whereas dynamic core training is not included in the protocol. Hence this study will observe the effect of including dynamic core training targeting the remaining core musculature as well in the FIFA 11 + program for risk factor modification and correction of muscular imbalance.
Detailed description
Soccer (football) is one of the most popular sports in the world. Intense soccer actions (i.e., acceleration, decelerations, change of direction, sprinting, tackling, running, being tackled, and shooting, twisting, turning, jumping and landing during the game) in addition to high impact and forceful body contacts during practice sessions and matches predispose the athletes to injuries. various contributing factors of these injuries include muscular imbalance, joint instability, lack of proper training and inadequate rehabilitation. Poor landing mechanics, specifically, increased dynamic knee valgus, is also associated with increased risk for lower limb injury, particularly ACL injury. The modifiable factors are shown to be responsive to different types of trainings. In fact neuromuscular factors are involved in control of dynamic knee stability, hamstrings and quadriceps imbalances, asymmetry of legs and core dysfunction. The latest FIFA 11+ developed in 2006 was designed to be used as pre-training protocol to improve the components of physical fitness that might contribute to injury prevention. In this program, there is a combination of three major exercise regime components: an initial running and stretching exercises, second component of strength, plyometric and balance exercises, ending with high speed planting and cutting exercises. One of the component of this program involves the training of core musculature. While the core muscles (including muscles of trunk and pelvis) do not cross the knee joint, yet core stability can modulate the lower limb alignment and loading during dynamic tasks. Hence, this study will be conducted to find whether there is any effect of including dynamic core training in the FIFA 11+ program in order to correct muscular imbalances and ultimately risk factor modification. A two-arm single blinded randomized controlled trial will be conducted to find out the dynamic knee valgus alignment, postural stability and single leg athletic stability and lower limb muscles strength, while the secondary outcomes would include lung function tests (FEV1, FVC \& FEV1/FVC ratio). In the control group, standard FIFA 11+Protocol will be followed consisting of slow paced running exercises followed by strength, plyometric and balance training. In the experimental group, FIFA 11+ protocol along with additional dynamic core exercises will be followed including leg raises, crunches, superman, plank hip twist, and supine bridge.All exercises in both groups will be progressively increased as per established protocol. Training will be provided 3-4 Times a week for 8 Weeks on alternate days.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Participants will be randomly allocated to Interventional Group A (FIFA 11+ with dynamic core stability training protocol) or Interventional Group B/ Control Group (FIFA 11+ protocol) for the whole duration of the study.
| Arm | Type | Receives |
|---|---|---|
| FIFA 11+ with dynamic core stability training | Experimental | Other: FIFA 11+ protocol with additional Core training exercisesParticipants in this group will undergo FIFA 11+ protocol along with additional Core training exercises including leg raises, crunches, superman, plank hip twist, and supine bridge will be given. Each exercise plan will be progressively increased. |
| FIFA 11+ protocol | Active comparator | Other: FIFA 11+ protocolParticipants in this group will undergo traditional FIFA 11+ protocol which consists of slow paced running exercises, strength, plyometric \& Balance exercises and high speed running with planting/cutting |
Who may qualify
- Ages
- 13 to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Both males and females
- Between the Age of 13-25 Years
- Participants will be selectively recruited with high risk of ACL/Knee Injury.
- Individuals of selected football academies, performing routine exercise according to the football academy.
- Able to provide informed consent by them self or from guardians
Key exclusion criteria (5 listed)
- Players having history of any Musculoskeletal Disorder or injury
- Players having recent injury resulting in at least 10-30 days off time from full training or matches.
- Players having history of skeletal trauma such as lower limb fractures.
- Players having history of any severe medical problems hindering regular participation in evaluation or training.
- Players using any nutritional supplements.
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 |
|---|---|---|
| FIFA 11+ protocol with additional Core training exercisesSlow paced running exercises of 8 minutes' duration (2 rounds each), followed by Strength, plyometric and balance exercises including 3 sets of 20-30 sec of The Bench, Sideways Bench each side, Nordic Hamstring strengthening, single leg stance balance training, squatting and high speed running. The protocol will end with additional core training exercises including leg raises, crunches, superman, plank hip twist, and supine bridge. Each exercise plan will be progressively increased. Core training will be followed by 30 sec stretch of major muscle groups. | Other | FIFA 11+ with dynamic core stability training |
| FIFA 11+ protocolSlow paced running exercises of 8 minutes' duration including running straight, running with hip out, running hip in, running circling partner, running shoulder contact and running quickly forward and backwards (2 rounds each), followed by Strength, plyometric and balance exercises including The Bench, Sideways Bench each side, Nordic Hamstring strengthening and single leg stance balance training, squatting and jumping. All exercises will be progressively increased as per established protocol. The final phase of the study includes fast running for 2 minutes. | Other | FIFA 11+ protocol |
Primary outcome
Dynamic Knee Valgus
Time frame: 8 weeks
Dynamic knee valgus will be measured using Motion Analysis System and expressed in form of degrees.
Single Leg Athletic Stability
Time frame: 8 weeks
Single Leg Athletic Stability will be measured using objective balance evaluation system.
1 secondary outcome
Lung function Test
Time frame: 8 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2022.
- 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.
Muhammad Salman Bashir, PhD principal investigator
Riphah International University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FIFA 11+ protocol with additional Core training exercises and FIFA 11+ protocol in people with Injury Prevention and Postural Balance, run by Riphah International University at 1 site in Pakistan.
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 5 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 2 Jun 2022. 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 Pakistan. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Muhammad Salman Bashir (00923334497959, salman.bashir@riphah.edu.pk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dynamic Knee Valgus (time frame: 8 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Jun 2022.