- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04958837
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
Recruiting
Conditions
Intervention / Treatment
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
Interventional
Enrollment (Anticipated)
40
Phase
- 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
- Name: Muhammad Salman Bashir
- Phone Number: 00923334497959
- Email: salman.bashir@riphah.edu.pk
Study Contact Backup
- Name: Muhammad Furqan Hassan
- Phone Number: 00923334056768
- Email: furqanhassan33@gmail.com
Study Locations
-
-
-
Islamabad, Pakistan, 44000
- Recruiting
- Foundaion University Institute of Rehabilitation Sciences
-
Contact:
- Furqan A Siddiqi, PhD
- Phone Number: 602 0092515788151
- Email: furqan@fui.edu.pk
-
-
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
Ages Eligible for Study
9 years to 21 years (Child, Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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.
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 |
Intervention / Treatment |
|---|---|
|
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.
|
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
|
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
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
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
Investigators
- 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)
July 15, 2021
Primary Completion (Anticipated)
June 30, 2022
Study Completion (Anticipated)
June 30, 2022
Study Registration Dates
First Submitted
July 6, 2021
First Submitted That Met QC Criteria
July 6, 2021
First Posted (Actual)
July 12, 2021
Study Record Updates
Last Update Posted (Actual)
June 2, 2022
Last Update Submitted That Met QC Criteria
May 31, 2022
Last Verified
May 1, 2022
More Information
Terms related to this study
Keywords
Other Study ID 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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