The Influence of 11+ on Injury Incidence and FMS-Score in... | NCT01993056

Studies
The Influence of 11+ on Injury Incidence and FMS-Score in Veteran Soccer Players

NCT01993056

Sponsor

Universität des Saarlandes

Status

Completed

Last Update Posted

Nov 25, 2013Estimated

Enrollment

265Actual

Phase

Not Applicable

Conditions

Injury

Interventions

"FIFA 11+"
no "FIFA 11+"

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2013

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2011

Primary Completion Date

Jun 2012Actual

Completion Date

Jun 2012Actual

First Submitted Date

Nov 19, 2013

First Submission Date that Met QC Criteria

Nov 22, 2013

First Posted Date

Nov 25, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 22, 2013

Last Update Posted Date

Nov 25, 2013Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Anne Krieg M.D., Dr, Universität des SaarlandesPrincipal Investigator

Lead Sponsor

Universität des SaarlandesOTHER

Collaborators

Name	Class
FIFA-Medical Assessment and Research Centre (F-MARC), Zurich, Switzerland	UNKNOWN

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

265Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
"FIFA 11+"	Behavioral		warm-up with 11+
no "FIFA 11+"

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
injury incidence	injury incidence (injuries per 1000h of soccer)	August 2011 - June 2012

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

major time-loss injury, chronic inflammatory joint disease

Accepts Healthy Volunteers

Yes

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

32 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Daniel Hammes	Saarland University, Institute for Sports and Preventive Medicine	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Saarland University		Saarbrücken	Saarland	66111	Germany

Condition Browse Module

MeSH Terms

ID	Term
D014947	Wounds and Injuries

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided