- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03415464
Prevention of Musculoskeletal Injuries in Slovenian Armed Forces
February 21, 2023 updated by: Vedran Hadzic, University of Ljubljana
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).
Study Overview
Status
Completed
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
160
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Ljubljana, Slovenia, 1000
- University in Ljubljana
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 55 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- no major injuries that would require more than 4 weeks to recover upon entry into the study
- age >18 y
- finished initial Army training
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Functional training
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.
|
neuromuscular training
|
No Intervention: Regular army training
Regular military training.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Soldiers With Ankle and Knee Injuries
Time Frame: 1 year
|
Percentage of soldiers with ankle and knee injuries during the study period.
|
1 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Vertical Jump Performance
Time Frame: 15 weeks
|
jump height in countermovement jump
|
15 weeks
|
Pull-ups Performance
Time Frame: 15 weeks
|
number of overhand pull-ups in one minute
|
15 weeks
|
Hamstring Repetitive Strength
Time Frame: 15 weeks
|
Number of single leg raises on the 60 cm box
|
15 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General 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. Erratum In: Mil Med. 2019 Mar 1;184(3-4):111.
- Vodicar 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.
- Simenko 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.
- Kozinc 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. 2021 Sep 7:bmjmilitary-2021-001899. doi: 10.1136/bmjmilitary-2021-001899. Online ahead of print.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 1, 2017
Primary Completion (Actual)
July 30, 2018
Study Completion (Actual)
September 30, 2018
Study Registration Dates
First Submitted
January 8, 2018
First Submitted That Met QC Criteria
January 29, 2018
First Posted (Actual)
January 30, 2018
Study Record Updates
Last Update Posted (Estimate)
February 23, 2023
Last Update Submitted That Met QC Criteria
February 21, 2023
Last Verified
February 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 630-1/2016-3
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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