Effects of FIFA 11+ With Dynamic Core Stability Training on Balance and Dynamic Knee Valgus in Amateur Soccer Players

May 31, 2022 updated by: Riphah International University

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
40

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Pakistan
      • Islamabad, Pakistan, 44000
        • Recruiting
        • Foundaion University Institute of Rehabilitation Sciences
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

9 years to 21 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Both males and females
  2. Between the Age of 13-25 Years
  3. Participants will be selectively recruited with high risk of ACL/Knee Injury.
  4. Individuals of selected football academies, performing routine exercise according to the football academy.
  5. Able to provide informed consent by them self or from guardians

Exclusion Criteria:

  1. Players having history of any Musculoskeletal Disorder or injury
  2. Players having recent injury resulting in at least 10-30 days off time from full training or matches.
  3. Players having history of skeletal trauma such as lower limb fractures.
  4. Players having history of any severe medical problems hindering regular participation in evaluation or training.
  5. Players using any nutritional supplements.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: FIFA 11+ with dynamic core stability training
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.
Other: FIFA 11+ protocol with additional Core training exercises
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.
Active Comparator: FIFA 11+ protocol
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
Other: FIFA 11+ protocol
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Dynamic Knee Valgus
Time Frame: 8 weeks
Dynamic knee valgus will be measured using Motion Analysis System and expressed in form of degrees.
8 weeks
Single Leg Athletic Stability
Time Frame: 8 weeks
Single Leg Athletic Stability will be measured using objective balance evaluation system.
8 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Lung function Test
Time Frame: 8 weeks
FEV1 & FCV will be measured using hand held spirometer dynamometer and expressed in form Liters.
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Riphah International University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Muhammad Salman Bashir, PhD, Riphah International University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 15, 2021

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 30, 2022

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 30, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 6, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 6, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 12, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 2, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 31, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2022

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • REC/RCR & AHS/21/1105

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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