Leg InjuriesKIPPNCT01406054
Neuromuscular Training to Reduce Sports Injuries Among Children and Adolescents
A study testing neuromuscular exercises in people with Leg Injuries, run by Ann & Robert H Lurie Children's Hospital of Chicago at 1 site in United States.
Trial summary
Sports-related injuries are a serious concern for physically active children and adolescents. Previous research, including ours at Chicago public high schools, shows our neuromuscular training program, the Knee Injury Prevention Program (KIPP) reduces sports-related injuries in female athletes by up to 88%. Read more about this study
- Who is it for?
- Ages 10 to 14 yearsHealthy volunteers can take part
- Conditions the study is for
- Leg Injuries
- What is being tested?
- neuromuscular exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2011to Jul 2021
- 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 10 to 14 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- sports coaches and physical education (PE) teachers for 5th-8th grade students at a CPS school
- 5th-8th grade students/athletes at a chicago public school
Who cannot join
- Not a coach or PE teacher at CPS
- not a 5th-8th grade student at CPS
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: Role of Neuromuscular Training in Reducing Sports Injuries and Improving Fitness Among Chicago Public Elementary and Middle School Students
Sports-related injuries are a serious concern for physically active children and adolescents. Previous research, including ours at Chicago public high schools, shows our neuromuscular training program, the Knee Injury Prevention Program (KIPP) reduces sports-related injuries in female athletes by up to 88%. However, KIPP is not well-studied in males or younger age groups. This project aims to determine KIPP's effect on sports-related injuries and physical fitness among 5th-8th grade students in Chicago public schools. The study will take place during the 2011-2013 school years. To measure KIPP's effect on sports injuries, we will recruit 5th-8th grade sports coaches and their athletes, randomize coaches by school into two groups, then train the intervention group to implement a 10-minute KIPP warm-up before practices and games. Control group will perform their usual warm-up. Research assistants will collect athlete participation and injury data from coaches weekly. To determine feasibility of KIPP in PE classes and measure its effect on fitness, we will recruit PE teachers to implement the warm-up in PE classes for a minimum of 10 weeks, and record students' presidential fitness test scores before and after the 10+ weeks. Results of this study will guide strategies for preventing sports-related injuries and improving physical fitness in 5th -8th graders.
Read the detailed description
PURPOSE OF THE RESEARCH
The long-term goal is to reduce sports-related injuries and improve physical fitness in children and adolescents by incorporating the neuromuscular training program called the Knee Injury Prevention Program (KIPP) into their physical education classes or sports practice routines. This project aims to measure the effectiveness of KIPP in reducing injuries and improving physical fitness among 5th -8th grade boys and girls in Chicago public schools. Specifically, the investigators aim to:
- Train PE teachers and sports coaches for 5th -8th grade students how to incorporate the 10-minute KIPP warm-up into their regular team practices and PE classes.
- Measure the effect of KIPP on sports injury rates.
- Measure the effect of KIPP on PE students' physical fitness.
LITERATURE REVIEW / JUSTIFICATION OF RESEARCH Sports-related injuries are a serious concern for physically active children and adolescents. Treatment costs can be substantial, and the time lost from school and sports can have considerable impact on mental health and academic performance. A handful of studies, including our previous research in CPS high schools, have shown that coach-led neuromuscular training (NMT) programs can reduce the risk for sports-related injuries among female high school athletes by up to 88%. However, few studies of NMT have included athletes under 14 years of age, and none have investigated the protective effect of NMT in sports other than soccer, basketball, volleyball and team handball. NMT includes exercises to strengthen the core and lower extremity muscles, improve balance and agility, and promote safe techniques with landing and pivoting which are the most common sports maneuvers that lead to injury.
In 2006, the investigators researched a coach-led neuromuscular training program called the Knee Injury Prevention Program (KIPP) for female soccer and basketball athletes in CPS high schools and found a statistically significant reduction in lower extremity injuries in the teams using the KIPP warm-up. KIPP should also have beneficial effects on physical fitness; however this has not yet been directly studied.
HYPOTHESES
- Coaches and PE teachers will demonstrate compliance and competency with implementing KIPP exercises into their regular practices/games and PE classes, respectively.
- KIPP training will reduce injuries in school-sponsored sports.
- KIPP training will improve PE students' physical fitness.
PRELIMINARY STUDIES From 2006 to 2007, we researched coach-led KIPP among female soccer and basketball athletes in Chicago Public High Schools and found significant reduction in lower extremity injuries. In 2005, we conducted a trial of pre-season KIPP for female adolescent athletes and found a reduction in subjects' sports-related knee pain pre- vs. post-training.
DESCRIPTION OF RESEARCH APPROACH This will be a cluster-randomized, controlled trial. The Acting Officer for the Office of Student Support and Engagement, the Director of Athletics for Chicago Public Schools (CPS), and the CPS Office of Student Health and Wellness understand and support the project's goals and research methods. CPS has agreed to provide PE teachers and coaches with staff development credits as an incentive to complete the study. The study will be implemented by "study personnel" who are all Lurie Children's-affiliated health care professionals or employees.
- Conditions
- Leg Injuries
- Being tested
- neuromuscular exercises
- Keywords
- athletes, injury prevention, neuromuscular training, public school, physical education, knee, sports, ACL, KIPP
- Medical subject headings
- Leg Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
neuromuscular exercisesOther
Also called KIPP
neuromuscular exercises delivered as a pre-practice and pre-game warm-up including dynamic stretching, strengthening, and plyometrics.
| Study group | Role | What they receive |
|---|---|---|
| neuromuscular training | Experimental | subjects in this arm will undergo neuromuscular warm-up exercises before practices and games Receives: Other: neuromuscular exercises |
| control | No intervention | subjects in the control arm will proceed to practice and games without additional neuromuscular warm-up exercises. |
What is being measured
The primary outcome is the main question the study is designed to answer.
sports-related lower extremity injuries
Frequency of injuries
Measured: 0-3 years
Secondary outcomes (1)
physical fitness as measured by presidential fitness test
Measured: 0-3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2011 (estimated)
- Study startJul 2011
- Primary completionJun 2020
- Study completionJul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Leg 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
- Single blind
- Who is masked
- Investigator
- Enrolment
- 400 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 LaBella, MD, Principal investigator, Ann & Robert H Lurie Children's Hospital of Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01406054
- Sponsor's protocol ID
- IRB 2011-14570
- Acronym
- KIPP
- Status last verified
- Nov 2024
- First submitted
- 28 Jul 2011
- Last updated
- 15 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Neuromuscular Training in Reducing Sports Injuries and Improving Fitness Among Chicago Public Elementary and Middle School Students
- ClinicalTrials.gov ID
- NCT01406054
- Acronym / sponsor ID
- KIPP / IRB 2011-14570
- Conditions
- Leg Injuries
- Keywords
- athletes, injury prevention, neuromuscular training, public school, physical education, knee, sports, ACL
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 400 participants (actual)
- Lead sponsor
- Ann & Robert H Lurie Children's Hospital of ChicagoUniversity, hospital or other
- Study start
- Jul 2011 (actual)
- Primary completion
- Jun 2020 (actual)
- Study completion
- Jul 2021 (actual)
- First posted
- 29 Jul 2011 (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.
Sports-related injuries are a serious concern for physically active children and adolescents. Previous research, including ours at Chicago public high schools, shows our neuromuscular training program, the Knee Injury Prevention Program (KIPP) reduces sports-related injuries in female athletes by up to 88%. However, KIPP is not well-studied in males or younger age groups. This project aims to determine KIPP's effect on sports-related injuries and physical fitness among 5th-8th grade students in Chicago public schools. The study will take place during the 2011-2013 school years. To measure KIPP's effect on sports injuries, we will recruit 5th-8th grade sports coaches and their athletes, randomize coaches by school into two groups, then train the intervention group to implement a 10-minute KIPP warm-up before practices and games. Control group will perform their usual warm-up. Research assistants will collect athlete participation and injury data from coaches weekly. To determine feasibility of KIPP in PE classes and measure its effect on fitness, we will recruit PE teachers to implement the warm-up in PE classes for a minimum of 10 weeks, and record students' presidential fitness test scores before and after the 10+ weeks. Results of this study will guide strategies for preventing sports-related injuries and improving physical fitness in 5th -8th graders.
Detailed description
PURPOSE OF THE RESEARCH
The long-term goal is to reduce sports-related injuries and improve physical fitness in children and adolescents by incorporating the neuromuscular training program called the Knee Injury Prevention Program (KIPP) into their physical education classes or sports practice routines. This project aims to measure the effectiveness of KIPP in reducing injuries and improving physical fitness among 5th -8th grade boys and girls in Chicago public schools. Specifically, the investigators aim to:
- Train PE teachers and sports coaches for 5th -8th grade students how to incorporate the 10-minute KIPP warm-up into their regular team practices and PE classes.
- Measure the effect of KIPP on sports injury rates.
- Measure the effect of KIPP on PE students' physical fitness.
LITERATURE REVIEW / JUSTIFICATION OF RESEARCH Sports-related injuries are a serious concern for physically active children and adolescents. Treatment costs can be substantial, and the time lost from school and sports can have considerable impact on mental health and academic performance. A handful of studies, including our previous research in CPS high schools, have shown that coach-led neuromuscular training (NMT) programs can reduce the risk for sports-related injuries among female high school athletes by up to 88%. However, few studies of NMT have included athletes under 14 years of age, and none have investigated the protective effect of NMT in sports other than soccer, basketball, volleyball and team handball. NMT includes exercises to strengthen the core and lower extremity muscles, improve balance and agility, and promote safe techniques with landing and pivoting which are the most common sports maneuvers that lead to injury.
In 2006, the investigators researched a coach-led neuromuscular training program called the Knee Injury Prevention Program (KIPP) for female soccer and basketball athletes in CPS high schools and found a statistically significant reduction in lower extremity injuries in the teams using the KIPP warm-up. KIPP should also have beneficial effects on physical fitness; however this has not yet been directly studied.
HYPOTHESES
- Coaches and PE teachers will demonstrate compliance and competency with implementing KIPP exercises into their regular practices/games and PE classes, respectively.
- KIPP training will reduce injuries in school-sponsored sports.
- KIPP training will improve PE students' physical fitness.
PRELIMINARY STUDIES From 2006 to 2007, we researched coach-led KIPP among female soccer and basketball athletes in Chicago Public High Schools and found significant reduction in lower extremity injuries. In 2005, we conducted a trial of pre-season KIPP for female adolescent athletes and found a reduction in subjects' sports-related knee pain pre- vs. post-training.
DESCRIPTION OF RESEARCH APPROACH This will be a cluster-randomized, controlled trial. The Acting Officer for the Office of Student Support and Engagement, the Director of Athletics for Chicago Public Schools (CPS), and the CPS Office of Student Health and Wellness understand and support the project's goals and research methods. CPS has agreed to provide PE teachers and coaches with staff development credits as an incentive to complete the study. The study will be implemented by "study personnel" who are all Lurie Children's-affiliated health care professionals or employees.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| neuromuscular training | Experimental | Other: neuromuscular exercisessubjects in this arm will undergo neuromuscular warm-up exercises before practices and games |
| control | No intervention | –subjects in the control arm will proceed to practice and games without additional neuromuscular warm-up exercises. |
Who may qualify
- Ages
- 10 to 14 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- sports coaches and physical education (PE) teachers for 5th-8th grade students at a CPS school
- 5th-8th grade students/athletes at a chicago public school
Key exclusion criteria (2 listed)
- Not a coach or PE teacher at CPS
- not a 5th-8th grade student at CPS
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 exercisesAlso: KIPPneuromuscular exercises delivered as a pre-practice and pre-game warm-up including dynamic stretching, strengthening, and plyometrics. | Other | neuromuscular training |
Primary outcome
sports-related lower extremity injuries
Time frame: 0-3 years
Frequency of injuries
1 secondary outcome
physical fitness as measured by presidential fitness test
Time frame: 0-3 years
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 15 Nov 2024.
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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 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 exercises in people with Leg 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 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: finished, as of the sponsor's last update on 15 Nov 2024. 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?
sports-related lower extremity injuries (time frame: 0-3 years). 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 15 Nov 2024.