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.
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
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.
- Conditions
- Musculoskeletal Injury
- 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 group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Neuromuscular exercise based injury-prevention program Receives: Other: Neuromuscular exercise based injury-prevention program |
| Control group | No intervention | Nonspecific 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.
Musculoskeletal injury incidence
Musculoskeletal injury incidence during study period
Measured: 6 month period
Secondary outcomes (9)
Age
years
Measured: Baseline and at 6 month
Body mass
kg
Measured: Baseline and at 6 month
Height
cm
Measured: Baseline and at 6 month
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
Postural sway
mm2; equivalent area of the center of pressure sway
Measured: Baseline and at 6 month
Isokinetic muscle strength
Nm; peak torque of knee flexion and extension was measured
Measured: Baseline and at 6 month
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
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
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.
- First posted13 Jan 2023
- Study start15 Dec 2019
- Primary completion16 Aug 2020
- Study completion16 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Musculoskeletal InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Estonian Military Academy
- Sponsor type
- University, hospital or other
- Collaborators
- University of Tartu, Tartu University Hospital
- Responsible party
- Sponsor
- Investigators
- Mati Pääsuke, PhD, Study director, University of TartuAhti Varblane, MD, Study chair, Estonian Military Academy
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
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Musculoskeletal Injury Risk in a Military Cadet Population Participating in an Injury-prevention Program
- ClinicalTrials.gov ID
- NCT05684003
- Acronym / sponsor ID
- 298/T-10
- Conditions
- Musculoskeletal Injury
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Estonian Military AcademyUniversity, hospital or other
- Collaborators
- University of Tartu, Tartu University Hospital
- Study start
- 15 Dec 2019 (actual)
- Primary completion
- 16 Aug 2020 (actual)
- Study completion
- 16 Aug 2020 (actual)
- First posted
- 13 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Other: Neuromuscular exercise based injury-prevention programNeuromuscular exercise based injury-prevention program |
| Control group | No intervention | –Nonspecific warm-up including a combination of aerobic exercises and range of motion exercises. |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Age 18-30 years
- Healthy volunteer
Key exclusion criteria (2 listed)
- Current injuries causing limited duty days
- Current injuries causing inability to participate in the proposed injury-prevention program.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Neuromuscular exercise based injury-prevention programNeuromuscular exercise based injury-prevention program | Other | Intervention group |
Primary outcome
Musculoskeletal injury incidence
Time frame: 6 month period
Musculoskeletal injury incidence during study period
9 secondary outcomes
Age
Time frame: Baseline and at 6 month
Body mass
Time frame: Baseline and at 6 month
Height
Time frame: Baseline and at 6 month
Body mass index
Time frame: Baseline and at 6 month
Postural sway
Time frame: Baseline and at 6 month
Isokinetic muscle strength
Time frame: Baseline and at 6 month
Isokinetic muscle strength ratio
Time frame: Baseline and at 6 month
Physical fitness
Time frame: Baseline and at 6 month
RAND 36-item survey scores
Time frame: Baseline and at 6 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mati Pääsuke, PhD study director
University of Tartu
Ahti Varblane, MD study chair
Estonian Military Academy
1 site in 1 country: see every site and its status.
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.