Knee InjuryNCT00894595
Preventing Knee Injuries in Adolescent Female Football Players
A study testing Knäkontroll, SISU Idrottsböcker©, Sweden, 2005 in people with Knee Injury, run by Region Skane at 1 site in Sweden.
Trial summary
Football-related knee injuries are common and especially the anterior cruciate ligament (ACL) injury constitute a serious problem in football regardless of the playing level. The purpose of this study is to conduct a randomized controlled trial evaluating the effect of a training program designed to prevent acute knee… Read more about this study
- Who is it for?
- Ages 13 to 17 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Knee Injury
- What is being tested?
- Knäkontroll, SISU Idrottsböcker©, Sweden, 2005
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4,564 participants
- Where
- 1 siteSweden
- Study dates
- Aug 2008to Oct 2010
- 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 13 to 17 years
- Women only
- Healthy volunteers accepted
- Child
Who may be able to join
- Teams with female football players aged 13-17 years
Who cannot join
- Teams that did not reply to the invitation or declined participation
- Teams having less than two scheduled training sessions per week
- Teams already using the preventive program
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Department of Medical and Health Sciences, Linköping University
Linköping, 581 83
About this study
Official title: Preventing Knee Injuries in Adolescent Female Football Players - Protocol of a Cluster-randomized Controlled Trial
Football-related knee injuries are common and especially the anterior cruciate ligament (ACL) injury constitute a serious problem in football regardless of the playing level. The purpose of this study is to conduct a randomized controlled trial evaluating the effect of a training program designed to prevent acute knee injury in female adolescent football players.
The investigators' hypotheses are:
- a preventive training program reduces the incidence of ACL injury, and
- a high match frequency and match play at senior level increase the risk of ACL injury.
- Conditions
- Knee Injury
- Being tested
- Knäkontroll, SISU Idrottsböcker©, Sweden, 2005
- Keywords
- Incidence of ACL injury, Risk factors for ACL injury, Prevention of ACL injury or any acute knee injury
- Medical subject headings
- Knee Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Knäkontroll, SISU Idrottsböcker©, Sweden, 2005Behavioural
The preventive program (Knäkontroll, SISU Idrottsböcker©, Sweden, 2005) consists of six exercises focusing on knee control and core stability and is performed during the warm-up at two training sessions per week throughout the 2009 competitive season.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | The clubs in the intervention group are instructed to perform a warm-up program at two training sessions per week throughout the entire 2009 competitive season. Receives: Behavioral: Knäkontroll, SISU Idrottsböcker©, Sweden, 2005 |
| Control group | Active comparator | The clubs in the control group are instructed to train and play as usual throughout the 2009 season Receives: Behavioral: Knäkontroll, SISU Idrottsböcker©, Sweden, 2005 |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence of ACL injury
Measured: One competitive football season
Secondary outcomes (1)
The incidence of any acute knee injury except contusion
Measured: One competitive football season
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2009 (estimated)
- Study startAug 2008
- Primary completionOct 2010
- Study completionOct 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Knee InjuryStudies of the same condition, open and under way.
- More trials run by Region SkaneThe sponsor's other registered studies.
- 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 4,564 participants (actual)
Sponsor and investigators
- Lead sponsor
- Region Skane
- Sponsor type
- University, hospital or other
- Collaborators
- Swedish Football Association, Folksam, Swedish National Centre for Research in Sports
- Investigators
- Markus Waldén, MD, PhD, Principal investigator, Linkoeping University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00894595
- Sponsor's protocol ID
- M197-08
- Status last verified
- Dec 2010
- First submitted
- 6 May 2009
- Last updated
- 4 Jan 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Walden M, Atroshi I, Magnusson H, Wagner P, Hagglund M. Prevention of acute knee injuries in adolescent female football players: cluster randomised controlled trial. BMJ. 2012 May 3;344:e3042. doi: 10.1136/bmj.e3042.
PubMed 22556050Hagglund M, Walden M, Atroshi I. Preventing knee injuries in adolescent female football players - design of a cluster randomized controlled trial [NCT00894595]. BMC Musculoskelet Disord. 2009 Jun 23;10:75. doi: 10.1186/1471-2474-10-75.
PubMed 19545453
Study at a glance
From the registry record, last updated by the sponsor on 4 Jan 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preventing Knee Injuries in Adolescent Female Football Players - Protocol of a Cluster-randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT00894595
- Acronym / sponsor ID
- M197-08
- Conditions
- Knee Injury
- Keywords
- Incidence of ACL injury, Risk factors for ACL injury, Prevention of ACL injury or any acute knee injury
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 4,564 participants (actual)
- Lead sponsor
- Region SkaneUniversity, hospital or other
- Collaborators
- Swedish Football Association, Folksam, Swedish National Centre for Research in Sports
- Study start
- Aug 2008
- Primary completion
- Oct 2010 (actual)
- Study completion
- Oct 2010 (actual)
- First posted
- 7 May 2009 (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.
Football-related knee injuries are common and especially the anterior cruciate ligament (ACL) injury constitute a serious problem in football regardless of the playing level. The purpose of this study is to conduct a randomized controlled trial evaluating the effect of a training program designed to prevent acute knee injury in female adolescent football players.
The investigators' hypotheses are:
- a preventive training program reduces the incidence of ACL injury, and
- a high match frequency and match play at senior level increase the risk of ACL injury.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Behavioral: Knäkontroll, SISU Idrottsböcker©, Sweden, 2005The clubs in the intervention group are instructed to perform a warm-up program at two training sessions per week throughout the entire 2009 competitive season. |
| Control group | Active comparator | Behavioral: Knäkontroll, SISU Idrottsböcker©, Sweden, 2005The clubs in the control group are instructed to train and play as usual throughout the 2009 season |
Who may qualify
- Ages
- 13 to 17 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Teams with female football players aged 13-17 years
Key exclusion criteria (3 listed)
- Teams that did not reply to the invitation or declined participation
- Teams having less than two scheduled training sessions per week
- Teams already using the preventive program
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 |
|---|---|---|
| Knäkontroll, SISU Idrottsböcker©, Sweden, 2005The preventive program (Knäkontroll, SISU Idrottsböcker©, Sweden, 2005) consists of six exercises focusing on knee control and core stability and is performed during the warm-up at two training sessions per week throughout the 2009 competitive season. | Behavioural | Control group, Intervention group |
Primary outcome
The incidence of ACL injury
Time frame: One competitive football season
1 secondary outcome
The incidence of any acute knee injury except contusion
Time frame: One competitive football season
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 4 Jan 2011.
- Derived from this study: PubMed 22556050Walden M, Atroshi I, Magnusson H, Wagner P, Hagglund M. Prevention of acute knee injuries in adolescent female football players: cluster randomised controlled trial. BMJ. 2012 May 3;344:e3042. doi: 10.1136/bmj.e3042.
- Derived from this study: PubMed 19545453Hagglund M, Walden M, Atroshi I. Preventing knee injuries in adolescent female football players - design of a cluster randomized controlled trial [NCT00894595]. BMC Musculoskelet Disord. 2009 Jun 23;10:75. doi: 10.1186/1471-2474-10-75.
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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.
Markus Waldén, MD, PhD principal investigator
Linkoeping University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Knäkontroll, SISU Idrottsböcker©, Sweden, 2005 in people with Knee Injury, run by Region Skane at 1 site in Sweden.
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 3 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 4 Jan 2011. 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 Sweden. 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.
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?
The incidence of ACL injury (time frame: One competitive football 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 NCT00894595, which also lists 2 linked publications.
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 4 Jan 2011.