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Prevention of Injuries and Musculoskeletal Disorders in the Defence Forces

Primary Purpose

Musculoskeletal Injury

Status
Completed
Phase
Not Applicable
Locations
Estonia
Study Type
Interventional
Intervention
Neuromuscular exercise based injury-prevention program
Sponsored by
Estonian Military Academy
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Musculoskeletal Injury

Eligibility Criteria

18 Years - 30 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion criteria: Age 18-30 years Healthy volunteer Exclusion criteria: Current injuries causing limited duty days Current injuries causing inability to participate in the proposed injury-prevention program.

Sites / Locations

  • University of Tartu, Faculty of Medicine, Institute of Sport Sciences and Physiotherapy

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention group

Control group

Arm Description

Neuromuscular exercise based injury-prevention program

Nonspecific warm-up including a combination of aerobic exercises and range of motion exercises.

Outcomes

Primary Outcome Measures

Musculoskeletal injury incidence
Musculoskeletal injury incidence during study period

Secondary Outcome Measures

Age
years
Body mass
kg
Height
cm
Body mass index
Based on body mass and height body mass index (BMI) was calculated (BMI = weight (kg) / height (m)²).
Postural sway
mm2; equivalent area of the center of pressure sway
Isokinetic muscle strength
Nm; peak torque of knee flexion and extension was measured
Isokinetic muscle strength ratio
%; Based on flexion-extension peak torque measurements hamstring/quadriceps ratio was calculated (H:Q = (flexion peak torque / extension peak torque) x 100%).
Physical fitness
Participant physical fitness was assessed with a test consisting of a 2-min maximal-effort push-up event (repetitions), a 2-min maximal-effort sit-up event (repetitions) and a 3.2 km timed run (minutes).
RAND 36-item survey scores
All items in this survey are scored on a scale from 0 to 100, with a high score defining a more favorable health state. For analysis, the following subscales were used: physical functioning, role limitations due to physical health problems, role limitations due to personal or emotional problems, energy/fatigue, emotional well-being, social functioning, bodily pain and general health perception.

Full Information

First Posted
January 2, 2023
Last Updated
January 4, 2023
Sponsor
Estonian Military Academy
Collaborators
University of Tartu, Tartu University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05684003
Brief Title
Prevention of Injuries and Musculoskeletal Disorders in the Defence Forces
Official Title
Musculoskeletal Injury Risk in a Military Cadet Population Participating in an Injury-prevention Program
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
December 15, 2019 (Actual)
Primary Completion Date
August 16, 2020 (Actual)
Study Completion Date
August 16, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Estonian Military Academy
Collaborators
University of Tartu, Tartu University Hospital

4. Oversight

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

5. Study Description

Brief Summary
The purpose of this study was to investigate the effect of an exercise-based injury-prevention program on the incidence of musculoskeletal injury, motor performance and psychosocial status. 36 Estonian Military Academy cadets were randomly assigned into either an intervention or control group. The intervention group followed a neuromuscular exercise-based injury-prevention warm-up program, 3 times per week for 6 months. The control group continued with the usual warm-up. The main outcome measure was injury incidence during the study period. Additionally, evaluation of isokinetic lower-extremity strength, postural sway, physical fitness and psychosocial status was included pre- and post-intervention.
Detailed Description
Injury incidence The primary outcome of interest in our study was incidence of musculoskeletal injury during the 6-month study period. Injury tracking was performed through the Estonian Defence Forces medical database. Since participants receive health care through the military health care system, any musculoskeletal condition severe enough to seek treatment from a medical provider is registered. Additionally, participants were asked to recall any musculoskeletal conditions at 3 and 6 months from the beginning of the study in order to catch potential injuries not reported to a military medical provider, or for which they might have obtained treatment from a nonmilitary medical care provider. Motor performance testing Prior to motor performance testing, baseline body mass (kg) and height (cm) were measured. Based on these body mass index (BMI) was calculated (BMI = weight (kg) / height (m)²). Before testing motor performance participants performed a 10-min individual warm-up - jogging, and range of motion and bodyweight strength exercises. Isokinetic muscle strength testing Strength parameters of the knee flexor and extensor muscles were recorded using a computerized dynamometer (CON-TREX® MJ, Physiomed Elektromedizin AG, Germany). Participants were seated upright with a hip flexion of 85°, the trunk stabilized with two 3-point seat belts and arms folded across the chest. The extremity to be tested was supported at the distal thigh with a Velcro strap. The distal shin adapter was attached 2-3 cm proximal to the lateral malleolus using a Velcro strap. The alignment of the rotational axis of the dynamometer was set so it would pass transversely through the femoral condyles, 1.5 finger width above joint space and vertical above head of fibula. The peak torque of knee flexion and extension was measured in concentric mode at an angular velocity of 60°/sec between a knee flexion of 10° and 90° (0° = full extension). For task-specific warm-up, the participants performed three submaximal knee flexion-extension movements. The test procedure included 3 maximal, consecutive flexion-extension movements. The participants were given verbal encouragement to flex and extend the leg as fast and forcefully as possible. Based on flexion-extension peak torque measurements hamstring/quadriceps ratio was calculated (H:Q = (flexion peak torque / extension peak torque) x 100%). Additionally, H:Q and peak torque differences between left and right lower extremity were calculated. Postural sway measurement A force platform (Kistler 9286A, Switzerland, dimensions 40 x 60cm) and biomechanical movement analysis system Elite Clinic with Sway software® (BTS S.p.A., Italy) were used to assess the equivalent area (EqArea) of the center of pressure sway. Participants were asked to maintain balance while standing on a single leg for 30 sec. For familiarization, the participants balanced 30 sec on each leg. Based on the measurements obtained, the difference of the EqArea between the left and right legs was calculated. Physical fitness test Participant physical fitness was assessed with a test consisting of a 2-min maximal-effort push-up event, a 2-min maximal-effort sit-up event and a 3.2 km timed run. Psychosocial status To assess participant psychosocial status, the RAND 36-item Health Survey 1.0 was used. All items in this survey are scored on a scale from 0 to 100, with a high score defining a more favorable health state. For analysis, the following subscales were used: physical functioning, role limitations due to physical health problems, role limitations due to personal or emotional problems, energy/fatigue, emotional well-being, social functioning, bodily pain and general health perception. Exercise intervention Participants in the INT group were asked to follow a prescribed injury-prevention program (PP) during warm-up before physical training for 6 months, 4 times per week. The PP was a structured warm-up routine, taking 20 min to finish. It was divided into 3 sequential parts: (1) whole-body range of motion and bodyweight strength exercises, (2) aerobic load - jogging, and (3) jump, balance and running exercises with a change of direction. A written PP description was provided. INT group participants were instructed on correct PP execution during a workshop led by a physical therapist. Also, detailed written instructions and online video materials were provided to ensure correct program execution. During the study period, no supervision on PP execution technique was provided. Participants in the CON group were asked to continue with their regular training and warm-up without any restrictions. The usual warm-up in the CON group involved a combination of aerobic exercises and range of motion exercises. Statistical analysis Descriptive statistics (mean, SD) in both groups were calculated. Differences between INT and CON groups were analyzed using an independent sample Student's t-test, and within-group differences between time points were analyzed using a dependent-sample paired t-test if the assumptions of a normal distribution and homogeneity of variances were satisfied. Normality of distribution was controlled using the Shapiro-Wilk test. Homogeneity of variances was controlled with Levene's test. If the previous assumptions for the t-test were not met, the between-group differences were analyzed with the non-parametric Wilcoxon test, and within-group differences between time points were analyzed using the dependent-sample paired Wilcoxon test. Bonferroni correction was applied to account for possible false positives due to the number of tests. Relative risk (RR) and 95% confidence intervals (95% CI) for between-group injury incidence were calculated. The level of significance was set at p < 0.05. R version 4.1.1 and RStudio version 1.4.1717 were used for statistical analysis.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Musculoskeletal Injury

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
36 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention group
Arm Type
Experimental
Arm Description
Neuromuscular exercise based injury-prevention program
Arm Title
Control group
Arm Type
No Intervention
Arm Description
Nonspecific warm-up including a combination of aerobic exercises and range of motion exercises.
Intervention Type
Other
Intervention Name(s)
Neuromuscular exercise based injury-prevention program
Intervention Description
Neuromuscular exercise based injury-prevention program
Primary Outcome Measure Information:
Title
Musculoskeletal injury incidence
Description
Musculoskeletal injury incidence during study period
Time Frame
6 month period
Secondary Outcome Measure Information:
Title
Age
Description
years
Time Frame
Baseline and at 6 month
Title
Body mass
Description
kg
Time Frame
Baseline and at 6 month
Title
Height
Description
cm
Time Frame
Baseline and at 6 month
Title
Body mass index
Description
Based on body mass and height body mass index (BMI) was calculated (BMI = weight (kg) / height (m)²).
Time Frame
Baseline and at 6 month
Title
Postural sway
Description
mm2; equivalent area of the center of pressure sway
Time Frame
Baseline and at 6 month
Title
Isokinetic muscle strength
Description
Nm; peak torque of knee flexion and extension was measured
Time Frame
Baseline and at 6 month
Title
Isokinetic muscle strength ratio
Description
%; Based on flexion-extension peak torque measurements hamstring/quadriceps ratio was calculated (H:Q = (flexion peak torque / extension peak torque) x 100%).
Time Frame
Baseline and at 6 month
Title
Physical fitness
Description
Participant physical fitness was assessed with a test consisting of a 2-min maximal-effort push-up event (repetitions), a 2-min maximal-effort sit-up event (repetitions) and a 3.2 km timed run (minutes).
Time Frame
Baseline and at 6 month
Title
RAND 36-item survey scores
Description
All items in this survey are scored on a scale from 0 to 100, with a high score defining a more favorable health state. For analysis, the following subscales were used: physical functioning, role limitations due to physical health problems, role limitations due to personal or emotional problems, energy/fatigue, emotional well-being, social functioning, bodily pain and general health perception.
Time Frame
Baseline and at 6 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion criteria: Age 18-30 years Healthy volunteer Exclusion criteria: Current injuries causing limited duty days Current injuries causing inability to participate in the proposed injury-prevention program.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mati Pääsuke, PhD
Organizational Affiliation
University of Tartu
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Ahti Varblane, MD
Organizational Affiliation
Estonian Military Academy
Official's Role
Study Chair
Facility Information:
Facility Name
University of Tartu, Faculty of Medicine, Institute of Sport Sciences and Physiotherapy
City
Tartu
ZIP/Postal Code
51008
Country
Estonia

12. IPD Sharing Statement

Plan to Share IPD
No

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Prevention of Injuries and Musculoskeletal Disorders in the Defence Forces

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