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Implementing a School Prevention Program to Reduce Injuries Through Neuromuscular Training (iSPRINT)

Primary Purpose

Wounds and Injuries, Adolescent, Athletic Injuries

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Neuromuscular training program
Standard-of-practice Warm-up (Control)
Sponsored by
Sport Injury Prevention Research Centre
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Wounds and Injuries focused on measuring sport injury, injury prevention, fitness, neuromuscular training, implementation

Eligibility Criteria

11 Years - 15 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    Neuromuscular Training Warm-up

    Control Standard-of-practice Warm-up

    Arm Description

    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.

    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.

    Outcomes

    Primary Outcome Measures

    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.

    Secondary Outcome Measures

    Changes in body mass index (BMI)
    Height (cm) and weight (kg) are measured at baseline, and again post-intervention at 3-months. Height and weight are used to calculate body mass index, calculated as: weight(kg)/height(m)^2
    Changes in waist circumference
    Waist circumference (cm) is measured at baseline, and again at 3-month follow-up once the intervention in complete. Waist circumference is measured following the Canadian Society for Exercise Physiology-Canadian Physical Activity, Fitness and Lifestyle Approach protocol: circumference is measured at the midpoint between the anterior superior iliac spine and the bottom of the ribs, at the end of a normal expiration while the participant crosses their arms over their chest.
    Changes in vertical jump height
    Vertical jump height (cm) is measured at baseline, and again post-intervention at 3-month follow-up. The height is calculated as the difference (in cm) between the standing reach height, and the maximum reach measured while jumping from the best of three trials.
    Changes in VO2max
    The PACER 20-m shuttle run is used to indirectly measure VO2max. Participants run the 20-m shuttle run at baseline, and again post-intervention at 3-month follow-up. Their score (recorded in number of laps) and used in a regression equation to predict maximal oxygen consumption.
    Changes in timed unipedal eyes-closed dynamic balance
    Balance times are measured at baseline, and again post-intervention at 3-month follow-up. The participant stands on an unstable foam pad (Airex balance pad) on one foot, with their eyes closed and hands on their hips. Time is recorded in seconds for each foot, and the best of three trials on each foot is used to assess changes.
    Changes in Y-balance reach distance
    Normalized composite reach distance is measured using the Y-balance test at baseline and again post-intervention at 3-month follow-up. The participant balances on one foot while pushing a sliding block as far as they can with their other foot, while maintaining balance. This is repeated for a total of three reach directions on each foot: anterior, postero-lateral, and postern-medial. Reach distances for each of the three directions are normalized as a percentage of leg length of the reaching leg, and summed to produce a normalized composite reach distance.

    Full Information

    First Posted
    October 4, 2017
    Last Updated
    April 1, 2020
    Sponsor
    Sport Injury Prevention Research Centre
    Collaborators
    Alberta Innovates Health Solutions, Calgary Board of Education, Calgary Catholic School District, Ever Active Schools, Policywise for Children and Families
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03312504
    Brief Title
    Implementing a School Prevention Program to Reduce Injuries Through Neuromuscular Training
    Acronym
    iSPRINT
    Official Title
    Evaluating the Effectiveness of Neuromuscular Training in Decreasing the Risk of Sport and Recreational Injuries and Improving Healthy Outcomes in Junior High School Students
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2020
    Overall Recruitment Status
    Unknown status
    Study Start Date
    September 1, 2014 (Actual)
    Primary Completion Date
    June 30, 2018 (Actual)
    Study Completion Date
    August 30, 2020 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Sport Injury Prevention Research Centre
    Collaborators
    Alberta Innovates Health Solutions, Calgary Board of Education, Calgary Catholic School District, Ever Active Schools, Policywise for Children and Families

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Wounds and Injuries, Adolescent, Athletic Injuries, Sport Injury, Sports Injuries in Children
    Keywords
    sport injury, injury prevention, fitness, neuromuscular training, implementation

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    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).
    Masking
    ParticipantInvestigator
    Masking Description
    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.
    Allocation
    Randomized
    Enrollment
    1067 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Neuromuscular Training Warm-up
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    Control Standard-of-practice Warm-up
    Arm Type
    Placebo Comparator
    Arm Description
    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.
    Intervention Type
    Other
    Intervention Name(s)
    Neuromuscular training program
    Intervention Description
    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).
    Intervention Type
    Other
    Intervention Name(s)
    Standard-of-practice Warm-up (Control)
    Intervention Description
    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).
    Primary Outcome Measure Information:
    Title
    Sport or recreational injury
    Description
    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.
    Time Frame
    Injuries are recorded if sustained at any point over the course of the study (each school participates for 3 months).
    Secondary Outcome Measure Information:
    Title
    Changes in body mass index (BMI)
    Description
    Height (cm) and weight (kg) are measured at baseline, and again post-intervention at 3-months. Height and weight are used to calculate body mass index, calculated as: weight(kg)/height(m)^2
    Time Frame
    Changes over a 3-month period.
    Title
    Changes in waist circumference
    Description
    Waist circumference (cm) is measured at baseline, and again at 3-month follow-up once the intervention in complete. Waist circumference is measured following the Canadian Society for Exercise Physiology-Canadian Physical Activity, Fitness and Lifestyle Approach protocol: circumference is measured at the midpoint between the anterior superior iliac spine and the bottom of the ribs, at the end of a normal expiration while the participant crosses their arms over their chest.
    Time Frame
    Changes over a 3-month period.
    Title
    Changes in vertical jump height
    Description
    Vertical jump height (cm) is measured at baseline, and again post-intervention at 3-month follow-up. The height is calculated as the difference (in cm) between the standing reach height, and the maximum reach measured while jumping from the best of three trials.
    Time Frame
    Changes over a 3-month period
    Title
    Changes in VO2max
    Description
    The PACER 20-m shuttle run is used to indirectly measure VO2max. Participants run the 20-m shuttle run at baseline, and again post-intervention at 3-month follow-up. Their score (recorded in number of laps) and used in a regression equation to predict maximal oxygen consumption.
    Time Frame
    Changes over a 3-month period
    Title
    Changes in timed unipedal eyes-closed dynamic balance
    Description
    Balance times are measured at baseline, and again post-intervention at 3-month follow-up. The participant stands on an unstable foam pad (Airex balance pad) on one foot, with their eyes closed and hands on their hips. Time is recorded in seconds for each foot, and the best of three trials on each foot is used to assess changes.
    Time Frame
    Changes over a 3-month period
    Title
    Changes in Y-balance reach distance
    Description
    Normalized composite reach distance is measured using the Y-balance test at baseline and again post-intervention at 3-month follow-up. The participant balances on one foot while pushing a sliding block as far as they can with their other foot, while maintaining balance. This is repeated for a total of three reach directions on each foot: anterior, postero-lateral, and postern-medial. Reach distances for each of the three directions are normalized as a percentage of leg length of the reaching leg, and summed to produce a normalized composite reach distance.
    Time Frame
    Changes over a 3-month period

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    11 Years
    Maximum Age & Unit of Time
    15 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: 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 Exclusion Criteria: 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

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    31822477
    Citation
    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.
    Results Reference
    result

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