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AzTrials

Musculoskeletal InjuryNCT05684003

Prevention of Injuries and Musculoskeletal Disorders in the Defence Forces

A study testing Neuromuscular exercise based injury-prevention program in people with Musculoskeletal Injury, run by Estonian Military Academy at 1 site in Estonia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 30 yearsHealthy volunteers can take part
Conditions the study is for
Musculoskeletal Injury
What is being tested?
Neuromuscular exercise based injury-prevention program
Could I receive a placebo?
No, everyone receives an active treatment
How many people
36 participants
Where
1 siteEstonia
Study dates
15 Dec 2019to 16 Aug 2020
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 18 to 30 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Age 18-30 years
  • Healthy volunteer

Who cannot join

  • Current injuries causing limited duty days
  • Current injuries causing inability to participate in the proposed injury-prevention program.

Trial locations and contacts

1 site in 1 country.

Estonia1 site
  • University of Tartu, Faculty of Medicine, Institute of Sport Sciences and Physiotherapy

    Tartu, 51008

Other trials in Estonia

About this study

Official title: Musculoskeletal Injury Risk in a Military Cadet Population Participating in an Injury-prevention Program

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.

Read the 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.

Being tested
Neuromuscular exercise based injury-prevention program

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Neuromuscular exercise based injury-prevention programOther

    Neuromuscular exercise based injury-prevention program

Study groups in NCT05684003
Study groupRoleWhat they receive
Intervention groupExperimentalNeuromuscular exercise based injury-prevention program
Receives: Other: Neuromuscular exercise based injury-prevention program
Control groupNo interventionNonspecific warm-up including a combination of aerobic exercises and range of motion exercises.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Musculoskeletal injury incidence

    Musculoskeletal injury incidence during study period

    Measured: 6 month period

Secondary outcomes (9)
  1. Age

    years

    Measured: Baseline and at 6 month

  2. Body mass

    kg

    Measured: Baseline and at 6 month

  3. Height

    cm

    Measured: Baseline and at 6 month

  4. Body mass index

    Based on body mass and height body mass index (BMI) was calculated (BMI = weight (kg) / height (m)²).

    Measured: Baseline and at 6 month

  5. Postural sway

    mm2; equivalent area of the center of pressure sway

    Measured: Baseline and at 6 month

  6. Isokinetic muscle strength

    Nm; peak torque of knee flexion and extension was measured

    Measured: Baseline and at 6 month

  7. 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%).

    Measured: Baseline and at 6 month

  8. 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).

    Measured: Baseline and at 6 month

  9. 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.

    Measured: Baseline and at 6 month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Jan 2023
  2. Study start15 Dec 2019
  3. Primary completion16 Aug 2020
  4. Study completion16 Aug 2020

Resources

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
None (open label)
Enrolment
36 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05684003
Sponsor's protocol ID
298/T-10
Status last verified
Jan 2023
First submitted
2 Jan 2023
Last updated
13 Jan 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Neuromuscular exercise based injury-prevention program in people with Musculoskeletal Injury, run by Estonian Military Academy at 1 site in Estonia.

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 13 Jan 2023. 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 Estonia. 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?

Musculoskeletal injury incidence (time frame: 6 month period). 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 13 Jan 2023.

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