Knee InjuriesNCT01092286
Effect of Neuromuscular Warm-up on Injuries in Female Athletes
A study testing neuromuscular warm-up in people with Knee Injuries and Anterior Cruciate Ligament Injuries, run by Ann & Robert H Lurie Children's Hospital of Chicago at 1 site in United States.
Trial summary
The goal of the study is to determine effect of coach-led neuromuscular warm-up on non-contact, lower extremity (LE) injury rates among female athletes in a predominantly non-white public high school system. The investigators hypothesized the warm-up would reduce non-contact LE injuries. Read more about this study
- Who is it for?
- Ages 14 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Knee Injuries, Anterior Cruciate Ligament Injuries, Ankle Injuries
- What is being tested?
- neuromuscular warm-up
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,653 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2006to Jul 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 14 to 80 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Willing to implement a new warm-up before their team's practices and games
- Willing to complete a pre- and post-season survey before and after using the warm-up program for one season (surveys are attached).
- Willing to complete a pre- and post-workshop test before and after the workshop (tests are attached).
- Willing to allow study personnel to observe their implementation of the warm-up at up to three team practices or games.
- Exclusion Criteria for coaches (current part of study) There are no separate exclusion criteria for coaches.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
Ann & Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinois, 60611
About this study
Official title: Effect of Neuromuscular Warm-up on Injuries in Female Athletes in Urban Public High Schools: A Cluster-randomized Controlled Trial
The goal of the study is to determine effect of coach-led neuromuscular warm-up on non-contact, lower extremity (LE) injury rates among female athletes in a predominantly non-white public high school system. The investigators hypothesized the warm-up would reduce non-contact LE injuries.
Read the detailed description
We will recruit basketball and soccer coaches and their athletes from Chicago public high schools. We will randomize teams to intervention and control groups. We will train intervention coaches to implement a 20-minute neuromuscular warm-up and tracked training costs. Control coaches will use their usual warm-up. All coaches will report weekly athlete exposures (AEs) and injuries resulting in a missed practice/game. Research assistants will interview injured athletes. We will compare injury rates between control and intervention groups.
- Conditions
- Knee Injuries, Anterior Cruciate Ligament Injuries, Ankle Injuries, Lower Extremity Injuries
- Being tested
- neuromuscular warm-up
- Keywords
- Knee injury, ankle sprain, anterior cruciate ligament, adolescent, soccer, basketball, prevention
- Medical subject headings
- Knee Injuries, Anterior Cruciate Ligament Injuries, Ankle Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
neuromuscular warm-upOther
Also called Knee Injury Prevention Program (KIPP)
neuromuscular warm-up exercises that take 20 minutes to perform
| Study group | Role | What they receive |
|---|---|---|
| neuromuscular warm-up | Experimental | coaches in this arm use the prescribed warm-up before team practices Receives: Other: neuromuscular warm-up |
| no warm-up | No intervention | coaches use their usual warm-up before team practices |
What is being measured
The primary outcome is the main question the study is designed to answer.
lower extremity injury rates
Measured: one year
Secondary outcomes (1)
coach compliance with warm-up
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2010 (estimated)
- Study startJul 2006
- Primary completionJul 2009
- Study completionJul 2009
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 Knee InjuriesStudies 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
- 1,653 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ann & Robert H Lurie Children's Hospital of Chicago
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cynthia LaBella, Ann & Robert H Lurie Children's Hospital of Chicago
- Investigators
- Cynthia R LaBella, MD, Principal investigator, Ann & Robert H Lurie Children's Hospital of Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01092286
- Sponsor's protocol ID
- IRB2006-12888
- Status last verified
- Jan 2018
- First submitted
- 23 Mar 2010
- Last updated
- 25 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
LaBella CR, Huxford MR, Grissom J, Kim KY, Peng J, Christoffel KK. Effect of neuromuscular warm-up on injuries in female soccer and basketball athletes in urban public high schools: cluster randomized controlled trial. Arch Pediatr Adolesc Med. 2011 Nov;165(11):1033-40. doi: 10.1001/archpediatrics.2011.168.
PubMed 22065184
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Neuromuscular Warm-up on Injuries in Female Athletes in Urban Public High Schools: A Cluster-randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01092286
- Acronym / sponsor ID
- IRB2006-12888
- Conditions
- Knee Injuries, Anterior Cruciate Ligament Injuries, Ankle Injuries, Lower Extremity Injuries
- Keywords
- Knee injury, ankle sprain, anterior cruciate ligament, adolescent, soccer, basketball, prevention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,653 participants (actual)
- Lead sponsor
- Ann & Robert H Lurie Children's Hospital of ChicagoUniversity, hospital or other
- Study start
- Jul 2006
- Primary completion
- Jul 2009 (actual)
- Study completion
- Jul 2009 (actual)
- First posted
- 24 Mar 2010 (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.
The goal of the study is to determine effect of coach-led neuromuscular warm-up on non-contact, lower extremity (LE) injury rates among female athletes in a predominantly non-white public high school system. The investigators hypothesized the warm-up would reduce non-contact LE injuries.
Detailed description
We will recruit basketball and soccer coaches and their athletes from Chicago public high schools. We will randomize teams to intervention and control groups. We will train intervention coaches to implement a 20-minute neuromuscular warm-up and tracked training costs. Control coaches will use their usual warm-up. All coaches will report weekly athlete exposures (AEs) and injuries resulting in a missed practice/game. Research assistants will interview injured athletes. We will compare injury rates between control and intervention groups.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| neuromuscular warm-up | Experimental | Other: neuromuscular warm-upcoaches in this arm use the prescribed warm-up before team practices |
| no warm-up | No intervention | –coaches use their usual warm-up before team practices |
Who may qualify
- Ages
- 14 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Willing to implement a new warm-up before their team's practices and games
- Willing to complete a pre- and post-season survey before and after using the warm-up program for one season (surveys are attached).
- Willing to complete a pre- and post-workshop test before and after the workshop (tests are attached).
- Willing to allow study personnel to observe their implementation of the warm-up at up to three team practices or games.
- Exclusion Criteria for coaches (current part of study) There are no separate exclusion criteria for coaches.
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| neuromuscular warm-upAlso: Knee Injury Prevention Program (KIPP)neuromuscular warm-up exercises that take 20 minutes to perform | Other | neuromuscular warm-up |
Primary outcome
lower extremity injury rates
Time frame: one year
1 secondary outcome
coach compliance with warm-up
Time frame: one year
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 25 Jan 2018.
- Derived from this study: PubMed 22065184LaBella CR, Huxford MR, Grissom J, Kim KY, Peng J, Christoffel KK. Effect of neuromuscular warm-up on injuries in female soccer and basketball athletes in urban public high schools: cluster randomized controlled trial. Arch Pediatr Adolesc Med. 2011 Nov;165(11):1033-40. doi: 10.1001/archpediatrics.2011.168.
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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.
Cynthia R LaBella, MD principal investigator
Ann & Robert H Lurie Children's Hospital of Chicago
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing neuromuscular warm-up in people with Knee Injuries and Anterior Cruciate Ligament Injuries, run by Ann & Robert H Lurie Children's Hospital of Chicago at 1 site in United States.
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 5 inclusion and 0 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 25 Jan 2018. 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 United States. 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?
lower extremity injury rates (time frame: one year). 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 NCT01092286, 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 25 Jan 2018.