NCT01993056

Brief Summary

According to available data the injury rate in male veteran soccer is high. Interventions to prevent injuries are requested. The 11+ warm-up program was developed by FIFA-experts and consists of several exercises with an overall-length of about 20 min. This study shall investigate the influence of 11+ on injury incidence and Functional Movement Screen (FMS)-Score in male veteran soccer players. Additionally it is to be examined if there is a relationship between FMS-Score and injury incidence. For this purpose the 11+-program is accomplished under supervised conditions over one regular season in a randomized-controlled study design. Injuries are documented via questionnaires in accordance with the FIFA-consensus-statement. FMS-Score is evaluated before and after the interventional period.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
265

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2011

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

Study Start

First participant enrolled

August 1, 2011

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2012

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

November 19, 2013

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 25, 2013

Completed
Last Updated

November 25, 2013

Status Verified

November 1, 2013

Enrollment Period

10 months

First QC Date

November 19, 2013

Last Update Submit

November 22, 2013

Conditions

Injury

Keywords

injury incidence, male veteran soccer, 11+, Functional Movement Screen, FMS, warm-up

Outcome Measures

Primary Outcomes (1)

  • injury incidence

    injury incidence (injuries per 1000h of soccer)

    August 2011 - June 2012

Study Arms (2)

warm-up with 11+

EXPERIMENTAL

The "FIFA 11+" is a complete warm up program aiming on reduce common soccer injuries

Behavioral: "FIFA 11+"

control

PLACEBO COMPARATOR

the control group follows its regular training routine

Behavioral: no "FIFA 11+"

Interventions

"FIFA 11+"BEHAVIORAL
warm-up with 11+
no "FIFA 11+"BEHAVIORAL
control

Eligibility Criteria

Age32 Years+
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • male veteran soccer players aged 32 and older, who are member of a club veteran team; training and matches on a regular basis

You may not qualify if:

  • major time-loss injury, chronic inflammatory joint disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Saarland University

Saarbrücken, Saarland, 66111, Germany

Location

MeSH Terms

Conditions

Wounds and Injuries

Study Officials

  • Daniel Hammes

    Saarland University, Institute for Sports and Preventive Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr

Study Record Dates

First Submitted

November 19, 2013

First Posted

November 25, 2013

Study Start

August 1, 2011

Primary Completion

June 1, 2012

Study Completion

June 1, 2012

Last Updated

November 25, 2013

Record last verified: 2013-11

Locations

DE(1)