NCT04958837

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2021

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 6, 2021

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 12, 2021

Completed
3 days until next milestone

Study Start

First participant enrolled

July 15, 2021

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2022

Completed
Last Updated

June 2, 2022

Status Verified

May 1, 2022

Enrollment Period

12 months

First QC Date

July 6, 2021

Last Update Submit

May 31, 2022

Conditions

Keywords

Exercise trainingknee jointsoccer

Outcome Measures

Primary Outcomes (2)

  • Dynamic Knee Valgus

    Dynamic knee valgus will be measured using Motion Analysis System and expressed in form of degrees.

    8 weeks

  • Single Leg Athletic Stability

    Single Leg Athletic Stability will be measured using objective balance evaluation system.

    8 weeks

Secondary Outcomes (1)

  • Lung function Test

    8 weeks

Study Arms (2)

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.

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

Other: FIFA 11+ protocol

Interventions

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+ with dynamic core stability training

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.

FIFA 11+ protocol

Eligibility Criteria

Age13 Years - 25 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Foundaion University Institute of Rehabilitation Sciences

Islamabad, 44000, Pakistan

RECRUITING

Study Officials

  • Muhammad Salman Bashir, PhD

    Riphah International University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Muhammad Salman Bashir

CONTACT

Muhammad Furqan Hassan

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
It will be a single blinded study. Only the participants will be masked.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 6, 2021

First Posted

July 12, 2021

Study Start

July 15, 2021

Primary Completion

June 30, 2022

Study Completion

June 30, 2022

Last Updated

June 2, 2022

Record last verified: 2022-05

Data Sharing

IPD Sharing
Will not share

Locations