StrainsNCT00557050
Acute Hamstring Strains in Danish Elite Soccer - Prevention and Rehabilitation
A study testing Training in people with Strains, run by Amager Hospital.
Trial summary
A common soft tissue injury in sports involving sprinting and jumping is the hamstring strain. Not much evidence-based research has been carried out on prevention of hamstring strains. Most studies suggest that hamstring strains occur during the later part of the swing phase when the player is sprinting. 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
- Strains
- What is being tested?
- Training
- How many people
- 1,000 participants
- Where
- No sites listed yet
- Study dates
- Jan 2008to Mar 2009
- 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 18 years and older
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male soccer player in one of the top 4 divisions i Denmark in the 2007/08 season
- Minimum 18 years old at the time for inclusion
Who cannot join
- Current hamstring strain at the time for inclusion
- Under 18 years old
About this study
A common soft tissue injury in sports involving sprinting and jumping is the hamstring strain.
Not much evidence-based research has been carried out on prevention of hamstring strains.
Read more
Most studies suggest that hamstring strains occur during the later part of the swing phase when the player is sprinting. In this phase the hamstring muscles are working to decelerate knee extension - that is, the muscle develops tension while lengthening. This means that the muscles change from functioning eccentrically to concentrically. We hypothesize that it is during this rapid change from eccentric to concentric function that the muscles are most vulnerable to injuries, and that the injuries can be prevented by increasing the eccentric muscle strength in the hamstring.
This randomized clinical trial will examine the effect of a 10-week preseason strength-training program in Danish elite soccer. The strength-training program focuses on eccentric hamstring training.
60 elite teams (1200 soccer players) will be cluster-randomized to either ordinary training or ordinary training combined with eccentric hamstring strength training. The training group will start the training program in the pre-season (10 weeks) and continue the training once a week during the following season.
Suspected hamstrings strains during the season will be examined within 3 days using ultrasound. Ultrasound verified hamstring strains will be registered, and players will start a standardized rehabilitation program.
- Conditions
- Strains
- Being tested
- Training
- Keywords
- Hamstring, Muscle, Injury, Prevention, Muscles
- Medical subject headings
- Sprains and Strains, Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TrainingOther
10-week eccentric hamstring muscle training
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of acute hamstring strains
Measured: one soccer season
Secondary outcomes (1)
Number of ACL-injuries
Measured: One soccer season
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Nov 2007 (estimated)
- Study startJan 2008
- Study completionMar 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for StrainsStudies 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
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Amager Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Jesper Petersen, MD, Principal investigator, Department of Orthopaedic Surgery, Amager University Hospital, Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00557050
- Sponsor's protocol ID
- H-A-2007-0062
- Status last verified
- Sep 2007
- First submitted
- 9 Nov 2007
- Last updated
- 12 Nov 2007
- Results posted
- No
- Data monitoring committee
- No
Publications
Petersen J, Holmich P. Evidence based prevention of hamstring injuries in sport. Br J Sports Med. 2005 Jun;39(6):319-23. doi: 10.1136/bjsm.2005.018549.
PubMed 15911599
Study at a glance
From the registry record, last updated by the sponsor on 12 Nov 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute Hamstring Strains in Danish Elite Soccer - Prevention and Rehabilitation
- ClinicalTrials.gov ID
- NCT00557050
- Acronym / sponsor ID
- H-A-2007-0062
- Conditions
- Strains
- Keywords
- Hamstring, Muscle, Injury, Prevention, Muscles
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Amager HospitalUniversity, hospital or other
- Study start
- Jan 2008
- Study completion
- Mar 2009 (estimated)
- First posted
- 12 Nov 2007 (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.
A common soft tissue injury in sports involving sprinting and jumping is the hamstring strain.
Not much evidence-based research has been carried out on prevention of hamstring strains.
Most studies suggest that hamstring strains occur during the later part of the swing phase when the player is sprinting. In this phase the hamstring muscles are working to decelerate knee extension - that is, the muscle develops tension while lengthening. This means that the muscles change from functioning eccentrically to concentrically. We hypothesize that it is during this rapid change from eccentric to concentric function that the muscles are most vulnerable to injuries, and that the injuries can be prevented by increasing the eccentric muscle strength in the hamstring.
This randomized clinical trial will examine the effect of a 10-week preseason strength-training program in Danish elite soccer. The strength-training program focuses on eccentric hamstring training.
60 elite teams (1200 soccer players) will be cluster-randomized to either ordinary training or ordinary training combined with eccentric hamstring strength training. The training group will start the training program in the pre-season (10 weeks) and continue the training once a week during the following season.
Suspected hamstrings strains during the season will be examined within 3 days using ultrasound. Ultrasound verified hamstring strains will be registered, and players will start a standardized rehabilitation program.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
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 soccer player in one of the top 4 divisions i Denmark in the 2007/08 season
- Minimum 18 years old at the time for inclusion
Key exclusion criteria (2 listed)
- Current hamstring strain at the time for inclusion
- Under 18 years old
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 |
|---|---|---|
| Training10-week eccentric hamstring muscle training | Other | – |
Primary outcome
Number of acute hamstring strains
Time frame: one soccer season
1 secondary outcome
Number of ACL-injuries
Time frame: One soccer season
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Nov 2007.
- Background: PubMed 15911599Petersen J, Holmich P. Evidence based prevention of hamstring injuries in sport. Br J Sports Med. 2005 Jun;39(6):319-23. doi: 10.1136/bjsm.2005.018549.
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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.
Jesper Petersen, MD principal investigator
Department of Orthopaedic Surgery, Amager University Hospital, Denmark
Questions about this trial
What is this clinical trial studying?
A study testing Training in people with Strains, run by Amager Hospital.
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 2 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 12 Nov 2007. Status can change between updates, so confirm with the study contact before making plans.
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.
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.
What does the primary outcome measure?
Number of acute hamstring strains (time frame: one soccer season). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00557050, which also lists 1 linked publication.
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 12 Nov 2007.