Groin Injuries in Football PlayersPhase 2/3NCT00226603
Lyske Trial (Danish) Groin Trial
A Phase 2/3 study testing Specific training programme (behavior) in people with Groin Injuries in Football Players, run by Hölmich, Per, M.D. at 1 site in Denmark.
Trial summary
To examine the effect of a specific training programme towards groin injuries in male footbal players. To evaluate the effect on other football related injuries as well. To examine any possible relations between various possible predictors such as experience, age, hypermobility and others, and the risk of sustaining… Read more about this study
- Who is it for?
- Ages 18 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Groin Injuries in Football Players
- What is being tested?
- Specific training programme (behavior)
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 1,600 participants
- Where
- 1 siteDenmark
- Study dates
- Sep 1997to Jun 1998
- Phase
- Phase 2/3
- 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 18 years and older
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- male adult football players playing in the participating clubs in the study period
- -
Who cannot join
- under 18 years groin injury at the start of the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prevention of Groin Injuries in Football Players
To examine the effect of a specific training programme towards groin injuries in male footbal players. To evaluate the effect on other football related injuries as well. To examine any possible relations between various possible predictors such as experience, age, hypermobility and others, and the risk of sustaining inujries during football.
- Conditions
- Groin Injuries in Football Players
- Being tested
- Specific training programme (behavior)
- Keywords
- groin injury, football, prevention, traing programme, cluster randomized study
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Specific training programme (behavior)Behavioural
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2005 (estimated)
- Study startSep 1997
- Study completionJun 1998
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Groin Injuries in Football PlayersStudies 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 2/3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Enrolment
- 1,600 participants
Sponsor and investigators
- Lead sponsor
- Hölmich, Per, M.D.
- Investigators
- Christian Gluud, PHD, Study chair, H:S Copenhagen Trial Unit
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00226603
- Sponsor's protocol ID
- KF 01-171/97
- Status last verified
- Jun 1998
- First submitted
- 23 Sep 2005
- Last updated
- 27 Sep 2005
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevention of Groin Injuries in Football Players
- ClinicalTrials.gov ID
- NCT00226603
- Acronym / sponsor ID
- KF 01-171/97
- Conditions
- Groin Injuries in Football Players
- Keywords
- groin injury, football, prevention, traing programme, cluster randomized study
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,600 participants
- Lead sponsor
- Hölmich, Per, M.D.
- Study start
- Sep 1997
- Study completion
- Jun 1998
- First posted
- 27 Sep 2005 (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.
To examine the effect of a specific training programme towards groin injuries in male footbal players. To evaluate the effect on other football related injuries as well. To examine any possible relations between various possible predictors such as experience, age, hypermobility and others, and the risk of sustaining inujries during football.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- male adult football players playing in the participating clubs in the study period
- -
Key exclusion criteria (1 listed)
- under 18 years groin injury at the start of the study
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 |
|---|---|---|
| Specific training programme (behavior) | Behavioural | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Sep 2005.
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.
Christian Gluud, PHD study chair
H:S Copenhagen Trial Unit
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Specific training programme (behavior) in people with Groin Injuries in Football Players, run by Hölmich, Per, M.D. at 1 site in Denmark.
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 2 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: status not confirmed, as of the sponsor's last update on 27 Sep 2005. 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 Denmark. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
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.
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 27 Sep 2005.