InjuryNCT01993056
The Influence of 11+ on Injury Incidence and FMS-Score in Veteran Soccer Players
A study testing "FIFA 11+" and no "FIFA 11+" in people with Injury, run by Universität des Saarlandes at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 32 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Injury
- What is being tested?
- "FIFA 11+" and no "FIFA 11+"
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 265 participants
- Where
- 1 siteGermany
- Study dates
- Aug 2011to Jun 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 32 years and older
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- male veteran soccer players aged 32 and older, who are member of a club veteran team; training and matches on a regular basis
Who cannot join
- major time-loss injury, chronic inflammatory joint disease
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Injury
- Being tested
- "FIFA 11+", no "FIFA 11+"
- Keywords
- injury incidence, male veteran soccer, 11+, Functional Movement Screen, FMS, warm-up
- Medical subject headings
- Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
"FIFA 11+"Behavioural
no "FIFA 11+"Behavioural
| Study group | Role | What they receive |
|---|---|---|
| warm-up with 11+ | Experimental | The "FIFA 11+" is a complete warm up program aiming on reduce common soccer injuries Receives: Behavioral: "FIFA 11+" |
| control | Placebo comparator | the control group follows its regular training routine Receives: Behavioral: no "FIFA 11+" |
What is being measured
The primary outcome is the main question the study is designed to answer.
injury incidence
injury incidence (injuries per 1000h of soccer)
Measured: August 2011 - June 2012
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2013 (estimated)
- Study startAug 2011
- Primary completionJun 2012
- Study completionJun 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 265 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universität des Saarlandes
- Sponsor type
- University, hospital or other
- Collaborators
- FIFA-Medical Assessment and Research Centre (F-MARC), Zurich, Switzerland
- Responsible party
- Principal investigator, Anne Krieg M.D., Universität des Saarlandes
- Investigators
- Daniel Hammes, Principal investigator, Saarland University, Institute for Sports and Preventive Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01993056
- Sponsor's protocol ID
- Saarland University 10/2011
- Status last verified
- Nov 2013
- First submitted
- 19 Nov 2013
- Last updated
- 25 Nov 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Influence of 11+ on Injury Incidence and FMS-Score in Veteran Soccer Players
- ClinicalTrials.gov ID
- NCT01993056
- Acronym / sponsor ID
- Saarland University 10/2011
- Conditions
- Injury
- Keywords
- injury incidence, male veteran soccer, 11+, Functional Movement Screen, FMS, warm-up
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 265 participants (actual)
- Lead sponsor
- Universität des SaarlandesUniversity, hospital or other
- Collaborators
- FIFA-Medical Assessment and Research Centre (F-MARC), Zurich, Switzerland
- Study start
- Aug 2011
- Primary completion
- Jun 2012 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 25 Nov 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| warm-up with 11+ | Experimental | Behavioral: "FIFA 11+"The "FIFA 11+" is a complete warm up program aiming on reduce common soccer injuries |
| control | Placebo comparator | Behavioral: no "FIFA 11+"the control group follows its regular training routine |
Who may qualify
- Ages
- 32 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- male veteran soccer players aged 32 and older, who are member of a club veteran team; training and matches on a regular basis
Key exclusion criteria (1 listed)
- major time-loss injury, chronic inflammatory joint disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| "FIFA 11+" | Behavioural | warm-up with 11+ |
| no "FIFA 11+" | Behavioural | control |
Primary outcome
injury incidence
Time frame: August 2011 - June 2012
injury incidence (injuries per 1000h of soccer)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Daniel Hammes principal investigator
Saarland University, Institute for Sports and Preventive Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing "FIFA 11+" and no "FIFA 11+" in people with Injury, run by Universität des Saarlandes at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Nov 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
injury incidence (time frame: August 2011 - June 2012). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Nov 2013.