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Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT03312504
Other study ID # REB14-0470
Secondary ID
Status Enrolling by invitation
Phase N/A
First received
Last updated
Start date September 1, 2014
Est. completion date August 30, 2020

Study information

Verified date April 2020
Source Sport Injury Prevention Research Centre
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Enrolling by invitation
Enrollment 1067
Est. completion date August 30, 2020
Est. primary completion date June 30, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 11 Years to 15 Years
Eligibility 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

Study Design


Intervention

Other:
Neuromuscular training program
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).
Standard-of-practice Warm-up (Control)
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).

Locations

Country Name City State
n/a

Sponsors (6)

Lead Sponsor Collaborator
Sport Injury Prevention Research Centre Alberta Innovates Health Solutions, Calgary Board of Education, Calgary Catholic School District, Ever Active Schools, Policywise for Children and Families

References & Publications (2)

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 thr — View Citation

Richmond SA, Donaldson A, Macpherson A, Bridel W, van den Berg C, Finch CF, Hagel B, Emery CA. Facilitators and Barriers to the Implementation of iSPRINT: A Sport Injury Prevention Program in Junior High Schools. Clin J Sport Med. 2018 Mar 26. doi: 10.109 — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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 over a 3-month period.
Secondary 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 over a 3-month period.
Secondary 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 over a 3-month period
Secondary 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 over a 3-month period
Secondary 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 over a 3-month period
Secondary 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. Changes over a 3-month period
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