Knee Injuries and DisordersNCT03415464
Prevention of Musculoskeletal Injuries in Slovenian Armed Forces
A study testing Exercise in people with Knee Injuries and Disorders and Ankle Injuries and Disorders, run by University of Ljubljana at 1 site in Slovenia.
Trial summary
Physical readiness of military personnel is a cornerstone of any army, as soldiers are expected to meet high physical demands on a daily basis, and soldiers must complete one hour of physical conditioning each day. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Knee Injuries and Disorders, Ankle Injuries and Disorders, Low Back Pain
- What is being tested?
- Exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteSlovenia
- Study dates
- 1 Jan 2017to 30 Sep 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- no major injuries that would require more than 4 weeks to recover upon entry into the study
- age >18 y
- finished initial Army training
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Physical readiness of military personnel is a cornerstone of any army, as soldiers are expected to meet high physical demands on a daily basis, and soldiers must complete one hour of physical conditioning each day. Participation in physical conditioning increases the risk of musculoskeletal injuries, and our 10-year retrospective analysis shows that 5% of soldiers sustain a sports injury during physical conditioning each year, and that ankle and knee injuries have the highest incidence rates of 25% and 20%, respectively. The primary objective of our study is to decrease the rate of ankle and knee injuries by implementing a preventive training program. The study is designed as a prospective randomized controlled trial with two arms (experimental and control).
Read the detailed description
Members of Slovenian Armed Forces - SAF (age range 18-51 years) are expected to participate in the study. Prior to recruitment the whole project will be explained to soldiers in a form of briefing during which they have the opportunity to ask and have answers to any questions concerning the nature of subsequent research. Following that explanation each participant will sign a consent form to voluntarily participate. No compensation will be given or promised for participation in a study that was approved by the Ethical board of the Faculty of Sport in Ljubljana (No. 454/2017). At the time of testing all soldiers must be free of acute injuries and should not reported any pain in musculo-skeletal system. Prior to the implementation of the preventive program all participants will underwent the set of functional testing that includes counterMovement jump (CMJ) testing, stork balANce test, pUll-ups, single leg hAmstrings bridge test, and loaded prone pLank test - MANUAL. Following initial testing a 15-week preventive training program will be implemented in experimental group, while control group will be training as usual. Following the intervention final testing will be performed to check for effectiveness of the intervention. After that a follow-up period will start during which injuries will be registered in both groups and later compared between groups (control and experimental) and within (2016-2017 injuries) groups to see if incidence rate of ankle and knee injuries has fallen.
- Being tested
- Exercise
- Medical subject headings
- Knee Injuries, Disease, Ankle Injuries, Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseOther
neuromuscular training
| Study group | Role | What they receive |
|---|---|---|
| Functional training | Experimental | 15 weeks of structured exercise intervention in the form of functional training. We have divided 15 weeks into 5 cycles each cycle lasting 3 weeks. Intervention will be administered twice per week, and each session will last 45 minutes.Each 45 minutes will be further divided into 10 minutes of functional warm-up, 30 minutes of neuromuscular training (strength, agility, balance, coordination) and 5 minutes of cool down. During the 3 week period the intensity of exercise will be increased with different form of same exercise, different number of repetitions and exercise duration. Receives: Other: Exercise |
| Regular army training | No intervention | Regular military training. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Soldiers With Ankle and Knee Injuries
Percentage of soldiers with ankle and knee injuries during the study period.
Measured: 1 year
Secondary outcomes (3)
Vertical Jump Performance
jump height in countermovement jump
Measured: 15 weeks
Pull-ups Performance
number of overhand pull-ups in one minute
Measured: 15 weeks
Hamstring Repetitive Strength
Number of single leg raises on the 60 cm box
Measured: 15 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2018
- Study start1 Jan 2017
- Primary completion30 Jul 2018
- Study completion30 Sep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Knee Injuries and DisordersStudies 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
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Ljubljana
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Vedran Hadzic, University of Ljubljana
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03415464
- Sponsor's protocol ID
- 630-1/2016-3
- Status last verified
- Feb 2023
- First submitted
- 8 Jan 2018
- Last updated
- 23 Feb 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Kovcan B, Vodicar J, Simenko J, Videmsek M, Pori P, Vedran H. Retrospective and Cross-sectional Analysis of Physical Training-Related Musculoskeletal Injuries in Slovenian Armed Forces. Mil Med. 2019 Jan 1;184(1-2):e195-e199. doi: 10.1093/milmed/usy156. No abstract available.
PubMed 29982738Vodicar M, Kovcan B, Pori P, Vodicar J, Simenko J, Karpljuk D, Markovic G, Hadzic V. Regular strength training and baseline fitness in overweight infantry members of Slovenian Armed Forces. BMJ Mil Health. 2022 Apr;168(2):141-145. doi: 10.1136/bmjmilitary-2020-001451. Epub 2020 Jun 2.
PubMed 32487675Simenko J, Kovcan B, Pori P, Vodicar J, Vodicar M, Hadzic V. The Relationship Between Army Physical Fitness and Functional Capacities in Infantry Members of the Slovenian Armed Forces. J Strength Cond Res. 2021 Dec 1;35(12):3506-3512. doi: 10.1519/JSC.0000000000003344.
PubMed 31800475Kozinc Z, Sarabon N, Kovcan B, Simenko J, Pori P, Vodicar J, Hadzic V. Effects of 12-week full body resistance exercise on vertical jumping with and without military equipment in Slovenian Armed Forces. BMJ Mil Health. 2023 Oct;169(5):391-396. doi: 10.1136/bmjmilitary-2021-001899. Epub 2021 Sep 7.
PubMed 34493610
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevention of Musculoskeletal Injuries in Slovenian Armed Forces
- ClinicalTrials.gov ID
- NCT03415464
- Acronym / sponsor ID
- 630-1/2016-3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- University of LjubljanaUniversity, hospital or other
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- 30 Jul 2018 (actual)
- Study completion
- 30 Sep 2018 (actual)
- First posted
- 30 Jan 2018 (actual)
- Results
- Posted 23 Feb 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Physical readiness of military personnel is a cornerstone of any army, as soldiers are expected to meet high physical demands on a daily basis, and soldiers must complete one hour of physical conditioning each day. Participation in physical conditioning increases the risk of musculoskeletal injuries, and our 10-year retrospective analysis shows that 5% of soldiers sustain a sports injury during physical conditioning each year, and that ankle and knee injuries have the highest incidence rates of 25% and 20%, respectively. The primary objective of our study is to decrease the rate of ankle and knee injuries by implementing a preventive training program. The study is designed as a prospective randomized controlled trial with two arms (experimental and control).
Detailed description
Members of Slovenian Armed Forces - SAF (age range 18-51 years) are expected to participate in the study. Prior to recruitment the whole project will be explained to soldiers in a form of briefing during which they have the opportunity to ask and have answers to any questions concerning the nature of subsequent research. Following that explanation each participant will sign a consent form to voluntarily participate. No compensation will be given or promised for participation in a study that was approved by the Ethical board of the Faculty of Sport in Ljubljana (No. 454/2017). At the time of testing all soldiers must be free of acute injuries and should not reported any pain in musculo-skeletal system. Prior to the implementation of the preventive program all participants will underwent the set of functional testing that includes counterMovement jump (CMJ) testing, stork balANce test, pUll-ups, single leg hAmstrings bridge test, and loaded prone pLank test - MANUAL. Following initial testing a 15-week preventive training program will be implemented in experimental group, while control group will be training as usual. Following the intervention final testing will be performed to check for effectiveness of the intervention. After that a follow-up period will start during which injuries will be registered in both groups and later compared between groups (control and experimental) and within (2016-2017 injuries) groups to see if incidence rate of ankle and knee injuries has fallen.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Functional training | Experimental | Other: Exercise15 weeks of structured exercise intervention in the form of functional training. We have divided 15 weeks into 5 cycles each cycle lasting 3 weeks. Intervention will be administered twice per week, and each session will last 45 minutes.Each 45 minutes will be further divided into 10 minutes of functional warm-up, 30 minutes of neuromuscular training (strength, agility, balance, coordination) and 5 minutes of cool down. During the 3 week period the intensity of exercise will be increased with different form of same exercise, different number of repetitions and exercise duration. |
| Regular army training | No intervention | –Regular military training. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- no major injuries that would require more than 4 weeks to recover upon entry into the study
- age >18 y
- finished initial Army training
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Exerciseneuromuscular training | Other | Functional training |
Primary outcome
Number of Soldiers With Ankle and Knee Injuries
Time frame: 1 year
Percentage of soldiers with ankle and knee injuries during the study period.
3 secondary outcomes
Vertical Jump Performance
Time frame: 15 weeks
Pull-ups Performance
Time frame: 15 weeks
Hamstring Repetitive Strength
Time frame: 15 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 29982738Kovcan B, Vodicar J, Simenko J, Videmsek M, Pori P, Vedran H. Retrospective and Cross-sectional Analysis of Physical Training-Related Musculoskeletal Injuries in Slovenian Armed Forces. Mil Med. 2019 Jan 1;184(1-2):e195-e199. doi: 10.1093/milmed/usy156. No abstract available.
- Results publication: PubMed 32487675Vodicar M, Kovcan B, Pori P, Vodicar J, Simenko J, Karpljuk D, Markovic G, Hadzic V. Regular strength training and baseline fitness in overweight infantry members of Slovenian Armed Forces. BMJ Mil Health. 2022 Apr;168(2):141-145. doi: 10.1136/bmjmilitary-2020-001451. Epub 2020 Jun 2.
- Results publication: PubMed 31800475Simenko J, Kovcan B, Pori P, Vodicar J, Vodicar M, Hadzic V. The Relationship Between Army Physical Fitness and Functional Capacities in Infantry Members of the Slovenian Armed Forces. J Strength Cond Res. 2021 Dec 1;35(12):3506-3512. doi: 10.1519/JSC.0000000000003344.
- Results publication: PubMed 34493610Kozinc Z, Sarabon N, Kovcan B, Simenko J, Pori P, Vodicar J, Hadzic V. Effects of 12-week full body resistance exercise on vertical jumping with and without military equipment in Slovenian Armed Forces. BMJ Mil Health. 2023 Oct;169(5):391-396. doi: 10.1136/bmjmilitary-2021-001899. Epub 2021 Sep 7.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise in people with Knee Injuries and Disorders and Ankle Injuries and Disorders, run by University of Ljubljana at 1 site in Slovenia.
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 3 inclusion and 0 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 23 Feb 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 Slovenia. 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?
Yes. Results are posted in the registry (first posted 23 Feb 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Soldiers With Ankle and Knee Injuries (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03415464, which also lists 4 linked publications.
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 23 Feb 2023.