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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04958837
Other study ID # REC/RCR & AHS/21/1105
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date July 15, 2021
Est. completion date June 30, 2022

Study information

Verified date May 2022
Source Riphah International University
Contact Muhammad Salman Bashir
Phone 00923334497959
Email salman.bashir@riphah.edu.pk
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 40
Est. completion date June 30, 2022
Est. primary completion date June 30, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 13 Years to 25 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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.
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.

Locations

Country Name City State
Pakistan Foundaion University Institute of Rehabilitation Sciences Islamabad

Sponsors (1)

Lead Sponsor Collaborator
Riphah International University

Country where clinical trial is conducted

Pakistan, 

Outcome

Type Measure Description Time frame Safety issue
Primary Dynamic Knee Valgus Dynamic knee valgus will be measured using Motion Analysis System and expressed in form of degrees. 8 weeks
Primary Single Leg Athletic Stability Single Leg Athletic Stability will be measured using objective balance evaluation system. 8 weeks
Secondary Lung function Test FEV1 & FCV will be measured using hand held spirometer dynamometer and expressed in form Liters. 8 weeks
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