Anterior Cruciate Ligament RupturePhase 2NCT00140270
RCT of PEP Program to Reduce ACL Injuries in Female Collegiate Soccer Players
A Phase 2 study testing PEP program in people with Anterior Cruciate Ligament Rupture, run by Centers for Disease Control and Prevention.
Trial summary
This research study involves implementing and evaluating a physical training program specifically designed to reduce the risk of ligamentous knee injuries in female soccer players by incorporating proven neuromuscular and proprioceptive training concepts into a concise, on-field warm-up activity. Read more about this study
- Who is it for?
- Ages 0 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Anterior Cruciate Ligament Rupture
- What is being tested?
- PEP program
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 4,000 participants
- Where
- No sites listed yet
- Study dates
- Aug 2002to Dec 2002
- Phase
- Phase 2
- 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 0 years and older
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Female soccer athlete on participating Division I women's soccer team
Who cannot join
- none
About this study
Official title: Evaluating the Effectiveness of a Neuromuscular and Proprioceptive Training Program to Reduce Ligamentous Knee Injuries Among Female Collegiate Soccer Players.
This research study involves implementing and evaluating a physical training program specifically designed to reduce the risk of ligamentous knee injuries in female soccer players by incorporating proven neuromuscular and proprioceptive training concepts into a concise, on-field warm-up activity. All 283 Division I NCAA women's soccer teams were asked to participate in this research study. Those that agreed were randomized to control (usual training program) and intervention (alternative warm-up program). Both groups of teams provided investigators with participation and knee injury information during the 15 week 2002 fall soccer season. Requested information included only that which would be readily available to the certified athletic trainers (ATC) in their normal course of duties. The knee injury rates among intervention team athletes were compared with control team athletes to determine program effectiveness. Data collection is complete and the report should be submitted shortly for publication.
Read the detailed description
This research study involves implementing and evaluating a physical training program specifically designed to reduce the risk of ligamentous knee injuries in female soccer players by incorporating proven neuromuscular and proprioceptive training concepts into a concise, on-field warm-up activity. All 283 Division I NCAA women's soccer teams were asked to participate in this research study. Those that agreed were randomized to control (usual training program) and intervention (alternative warm-up program). Both groups of teams provided investigators with participation and knee injury information during the 15 week 2002 fall soccer season. Requested information included only that which would be readily available to the certified athletic trainers (ATC) in their normal course of duties. The knee injury rates among intervention team athletes were compared with control team athletes to determine program effectiveness. Data collection is complete and the report should be submitted shortly for publication.
- Conditions
- Anterior Cruciate Ligament Rupture
- Being tested
- PEP program
- Medical subject headings
- Anterior Cruciate Ligament Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PEP programBehavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
Ligamentous knee and ankle injuries;
specific interest is the ACL
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2005 (estimated)
- Study startAug 2002
- Study completionDec 2002
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anterior Cruciate Ligament RuptureStudies 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
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 4,000 participants
Sponsor and investigators
- Lead sponsor
- Centers for Disease Control and Prevention
- Sponsor type
- US federal agency
- Investigators
- Julie Gilchrist, MD, Principal investigator, Centers for Disease Control and Prevention
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00140270
- Sponsor's protocol ID
- CDC-NCIPC-3185
- Status last verified
- Aug 2005
- First submitted
- 30 Aug 2005
- Last updated
- 1 Sep 2005
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Effectiveness of a Neuromuscular and Proprioceptive Training Program to Reduce Ligamentous Knee Injuries Among Female Collegiate Soccer Players.
- ClinicalTrials.gov ID
- NCT00140270
- Acronym / sponsor ID
- CDC-NCIPC-3185
- Conditions
- Anterior Cruciate Ligament Rupture
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 4,000 participants
- Lead sponsor
- Centers for Disease Control and PreventionUS federal agency
- Study start
- Aug 2002
- Study completion
- Dec 2002
- First posted
- 1 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.
This research study involves implementing and evaluating a physical training program specifically designed to reduce the risk of ligamentous knee injuries in female soccer players by incorporating proven neuromuscular and proprioceptive training concepts into a concise, on-field warm-up activity. All 283 Division I NCAA women's soccer teams were asked to participate in this research study. Those that agreed were randomized to control (usual training program) and intervention (alternative warm-up program). Both groups of teams provided investigators with participation and knee injury information during the 15 week 2002 fall soccer season. Requested information included only that which would be readily available to the certified athletic trainers (ATC) in their normal course of duties. The knee injury rates among intervention team athletes were compared with control team athletes to determine program effectiveness. Data collection is complete and the report should be submitted shortly for publication.
Detailed description
This research study involves implementing and evaluating a physical training program specifically designed to reduce the risk of ligamentous knee injuries in female soccer players by incorporating proven neuromuscular and proprioceptive training concepts into a concise, on-field warm-up activity. All 283 Division I NCAA women's soccer teams were asked to participate in this research study. Those that agreed were randomized to control (usual training program) and intervention (alternative warm-up program). Both groups of teams provided investigators with participation and knee injury information during the 15 week 2002 fall soccer season. Requested information included only that which would be readily available to the certified athletic trainers (ATC) in their normal course of duties. The knee injury rates among intervention team athletes were compared with control team athletes to determine program effectiveness. Data collection is complete and the report should be submitted shortly for publication.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 0 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Female soccer athlete on participating Division I women's soccer team
Key exclusion criteria (1 listed)
- none
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 |
|---|---|---|
| PEP program | Behavioural | – |
Primary outcome
Ligamentous knee and ankle injuries;
specific interest is the ACL
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 1 Sep 2005.
- site has description of the intervention under studyLink provided by the sponsor.
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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.
Julie Gilchrist, MD principal investigator
Centers for Disease Control and Prevention
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing PEP program in people with Anterior Cruciate Ligament Rupture, run by Centers for Disease Control and Prevention.
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 1 Sep 2005. 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.
What does this 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.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Ligamentous knee and ankle injuries;. The study lists 2 primary outcomes in all. 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 1 Sep 2005.