NCT03312504

Brief Summary

The purpose of this study is to evaluate the effectiveness of a neuromuscular training program in decreasing sport and recreational injuries and improving healthy outcomes in junior high school students (grades 7 to 9). The neuromuscular training program is implemented as a 15-minute warm-up at the beginning of the students' physical education classes over a three-month period. This study is a randomized controlled trial design, involving twelve schools over a three-year period. Upon enrolment into the study, schools are randomly assigned to the intervention (neuromuscular training) group, or the control group. The control group includes a standard-of practice warm-up consisting of aerobic components and static stretching. A study athletic therapist visits the schools each week to assess and record information on any injuries sustained by study participants. Baseline health and physical fitness is measured at baseline, and again at 3-month follow-up in study participants to assess changes over the course of the program.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,067

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2014

Longer than P75 for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2014

Completed
3.1 years until next milestone

First Submitted

Initial submission to the registry

October 4, 2017

Completed
13 days until next milestone

First Posted

Study publicly available on registry

October 17, 2017

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2018

Completed
2.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2020

Completed
Last Updated

April 3, 2020

Status Verified

April 1, 2020

Enrollment Period

3.8 years

First QC Date

October 4, 2017

Last Update Submit

April 1, 2020

Conditions

Keywords

sport injuryinjury preventionfitnessneuromuscular trainingimplementation

Outcome Measures

Primary Outcomes (1)

  • Sport or recreational injury

    Any injury sustained through a sport or recreational activity that resulted in time loss from physical activity participation (unable to return to the same session or missed at least one day of participation), or required medical attention.

    Injuries are recorded if sustained at any point over the course of the study (each school participates for 3 months).

Secondary Outcomes (6)

  • Changes in body mass index (BMI)

    Changes over a 3-month period.

  • Changes in waist circumference

    Changes over a 3-month period.

  • Changes in vertical jump height

    Changes over a 3-month period

  • Changes in VO2max

    Changes over a 3-month period

  • Changes in timed unipedal eyes-closed dynamic balance

    Changes over a 3-month period

  • +1 more secondary outcomes

Study Arms (2)

Neuromuscular Training Warm-up

EXPERIMENTAL

Schools randomized to the intervention arm receive a workshop outlining a neuromuscular training program to be used as a warm-up for 15 minutes at the beginning of each physical education class. The warm-up consist of high-intensity aerobic, strengthening, agility, plyometric, and balance components. The workshop is designed to last two hours, and includes a video outlining the warm-up components, practice time, and group discussions for action planning to address potential barriers to the program.

Other: Neuromuscular training program

Control Standard-of-practice Warm-up

PLACEBO COMPARATOR

Schools randomized to the control arm receive a workshop outlining a standard-of-practice program to be used as a warm-up for 15 minutes at the beginning of each physical education class. The warm-up consists of aerobic exercises and static stretching. The workshop is designed to last one hour, and includes an explanation and demonstration of the exercises, but no video or practice time.

Other: Standard-of-practice Warm-up (Control)

Interventions

This is a 15-minute warm-up program designed to be implemented at the beginning of junior high school physical education classes. This warm-up is comprised of 15 components; nine of which are aerobic exercises (forward running, forward run with skipping, forward run with knee lifts, forward run with heel kicks, sideways shuffles, zigzag running, forward running with intermittent stops, speed runs, and squat/skate jumps), and six of which are balance/strengthening exercises (front plank, side plank, nordic hamstring exercise, lunges, balancing on the wobble board, and balancing on foam balance pads).

Neuromuscular Training Warm-up

This is a 15-minute warm-up program designed to be implemented at the beginning of junior high school physical education classes. This warm-up is comprised of 16 components; seven of which are aerobic exercises (forward running, forward running with arm swings, side shuffling, lunging, skipping, arm running with arm swings, and cool-down running), and nine of which are static stretching exercises (standing quadriceps, standing hamstrings, standing calf, standing groin, rotating ankle, lunges, standing shoulder, standing triceps, standing neck).

Control Standard-of-practice Warm-up

Eligibility Criteria

Age11 Years - 15 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • SCHOOLS
  • junior high schools with a minimum of two physical education classes per week, per class
  • physical education classes that are taught or co-taught by a physical education specialist
  • SUBJECTS
  • students aged 11-15 who are fully participating in physical education curriculum at baseline
  • students who return completed assent and parental consent forms

You may not qualify if:

  • SCHOOLS
  • schools that are culturally distinct
  • schools that have students that are of single sex
  • schools that cater to students with special needs
  • schools with incomplete grades
  • SUBJECTS
  • history of musculoskeletal disorders or medical condition that prevents participation in regular physical education curriculum
  • history of musculoskeletal injury within 6 weeks prior to study commencement that restricts full participation in physical education
  • at least 80% of participation in physical education classes over the course of the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Emery CA, van den Berg C, Richmond SA, Palacios-Derflingher L, McKay CD, Doyle-Baker PK, McKinlay M, Toomey CM, Nettel-Aguirre A, Verhagen E, Belton K, Macpherson A, Hagel BE. Implementing a junior high school-based programme to reduce sports injuries through neuromuscular training (iSPRINT): a cluster randomised controlled trial (RCT). Br J Sports Med. 2020 Aug;54(15):913-919. doi: 10.1136/bjsports-2019-101117. Epub 2019 Dec 10.

MeSH Terms

Conditions

Wounds and InjuriesAthletic Injuries

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Masking Details
Participants (teachers and students) are not aware of what arm they are randomized to; however, they are aware that there are two arms. The primary investigators performing the analysis and overseeing all decisions are blinded to the schools receiving the intervention vs control program.
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Randomized controlled trial. Upon enrolment into the study, a school will be randomly assigned to the intervention (neuromuscular training warm-up) or control group (standard-of-practice warm-up). Schools that have been randomized to the control arm will be invited to participate in the study in the following year as an intervention school. Schools that have been randomized to the intervention arm will be invited to participate in the study in the following year as a maintenance school (will continue with the intervention).
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 4, 2017

First Posted

October 17, 2017

Study Start

September 1, 2014

Primary Completion

June 30, 2018

Study Completion

August 30, 2020

Last Updated

April 3, 2020

Record last verified: 2020-04