NCT03513978

Brief Summary

The prevention of injuries has a close relation with the proprioception. In this sense, the proprioception is defined as the information about the corporal and segmental movement, as well as the position of the body and the corporal segments of oneself in the space. Some authors divide the proprioception into kinesthesia and the Joint Position Sense (JPS). The hypothesis of the study is the implantation of a progressive multimodal exercise protocol with transferences to sport in the trainings of amateur male soccer players in the age range from 18 to 30 years, can decrease the adverse effects of the fatigue during the high intensity activities and its relation with the JPS. Due to the close relation between fatigue and incidence of injuries, the obtaining of positive results could be an important finding for the design of prevention and rehabilitation protocols in soccer.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

March 26, 2018

Completed
1 month until next milestone

Study Start

First participant enrolled

April 30, 2018

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 2, 2018

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2018

Completed
Last Updated

November 6, 2018

Status Verified

November 1, 2018

Enrollment Period

6 months

First QC Date

March 26, 2018

Last Update Submit

November 5, 2018

Conditions

Keywords

SoccerPrevention injury

Outcome Measures

Primary Outcomes (2)

  • Joint Position Sense of the knee

    A digital inclinometer (range measured in degreesº) was used to assess knee Joint Position Sense in a Closed Kinetic Chain using an active modality (athletes actively reached and maintained the knee). The athletes did three trials to the target position. The average of three trials was used to compared with the target position to obtain the absolute error and relative error.

    Was measured at baseline (realized before the training), post-treatment (six weeks, realized before the training), ten weeks (before the training) and three months (realized before the trainng)

  • Joint Position Sense of the knee after the training

    A digital inclinometer (range measured in degreesº) was used to assess knee Joint Position Sense in a Closed Kinetic Chain using an active modality (athletes actively reached and maintained the knee). The athletes did three trials to the target position. The average of three trials was used to compared with the target position to obtain the absolute error and relative error.

    Was measured at baseline (realized after the training), post-treatment (six weeks, realized after the training) and three months (realized after the trainng)

Secondary Outcomes (3)

  • Fatigue

    Was measured at baseline (after the training), post-treatment (six weeks, after the training), and three months (after the training

  • Lateral Step Down Test

    Was measured at baseline (realized before and after the training), post-treatment (six weeks, realized before and after the training), ten weeks (realized only before the training) and three months (realized before and after the training

  • Counter movement jump

    Was measured at baseline (realized before and after the training), post-treatment (six weeks, realized before and after the training), ten weeks (realized only before the training) and three months (realized before and after the training

Study Arms (2)

IAI Protocol

EXPERIMENTAL

A progressive exercises with transference to sport protocol, oriented to improve the proprioception.

Other: IAI Exercises Protocol

FIFA 11+ Protocol

ACTIVE COMPARATOR

A typical exercises protocol to soccer

Other: FIFA 11+

Interventions

Progressive exercises to improve the strength and propioception of the male soccer players.

IAI Protocol

Progressive exercises protocol to prevent injuries in male soccer players which has been created by "FIFA". It is based in different body wieght exercises to improve the neuromuscular control and stabilization.

FIFA 11+ Protocol

Eligibility Criteria

Age18 Years - 40 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Soccer Players inscribed in Madrid's Soccer Confederation, who have not been sufferd any injury in the last three months and had been trainning regularly in the last six weeks.

You may not qualify if:

  • Soccer Players who had been suffered any severe injury in the last six months like (1) fracture in the low limb, (2) ACL injury, (3) grade III ankle sprain or (4) any surgical intervention in the low limb.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Plaza de los Irlandeses, Nº 12, 2º C

Alcalá de Henares, Madrid, 28801, Spain

Location

Study Officials

  • Marcos Jose Navarro Santana, MSc

    Alcala University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator.

Study Record Dates

First Submitted

March 26, 2018

First Posted

May 2, 2018

Study Start

April 30, 2018

Primary Completion

November 1, 2018

Study Completion

November 1, 2018

Last Updated

November 6, 2018

Record last verified: 2018-11

Locations