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Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT00557050
Other study ID # H-A-2007-0062
Secondary ID
Status Enrolling by invitation
Phase N/A
First received November 9, 2007
Last updated November 9, 2007
Start date January 2008
Est. completion date March 2009

Study information

Verified date September 2007
Source Amager Hospital
Contact n/a
Is FDA regulated No
Health authority Denmark: The Danish National Committee on Biomedical Research Ethics
Study type Interventional

Clinical 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. 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.


Recruitment information / eligibility

Status Enrolling by invitation
Enrollment 1000
Est. completion date March 2009
Est. primary completion date
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 18 Years and older
Eligibility Inclusion Criteria:

- 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

Exclusion Criteria:

- Current hamstring strain at the time for inclusion

- Under 18 years old

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention


Related Conditions & MeSH terms


Intervention

Other:
Training
10-week eccentric hamstring muscle training

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Amager Hospital

References & Publications (1)

Petersen J, Hölmich P. Evidence based prevention of hamstring injuries in sport. Br J Sports Med. 2005 Jun;39(6):319-23. Review. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Number of acute hamstring strains one soccer season
Secondary Number of ACL-injuries One soccer season
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