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Prevention of Musculoskeletal Injuries in Slovenian Armed Forces

Primary Purpose

Knee Injuries and Disorders, Ankle Injuries and Disorders, Low Back Pain

Status
Completed
Phase
Not Applicable
Locations
Slovenia
Study Type
Interventional
Intervention
Exercise
Sponsored by
University of Ljubljana
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Knee Injuries and Disorders

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • no major injuries that would require more than 4 weeks to recover upon entry into the stufy
  • age >18 y
  • finished initial Army training

Sites / Locations

  • University in Ljubljana

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Functional training

Regular army training

Arm Description

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.

Regular military training.

Outcomes

Primary Outcome Measures

Number of Soldiers With Ankle and Knee Injuries
Percentage of soldiers with ankle and knee injuries during the study period.

Secondary Outcome Measures

Vertical Jump Performance
jump height in countermovement jump
Pull-ups Performance
number of overhand pull-ups in one minute
Hamstring Repetitive Strength
Number of single leg raises on the 60 cm box

Full Information

First Posted
January 8, 2018
Last Updated
February 21, 2023
Sponsor
University of Ljubljana
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1. Study Identification

Unique Protocol Identification Number
NCT03415464
Brief Title
Prevention of Musculoskeletal Injuries in Slovenian Armed Forces
Official Title
Prevention of Musculoskeletal Injuries in Slovenian Armed Forces
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
January 1, 2017 (Actual)
Primary Completion Date
July 30, 2018 (Actual)
Study Completion Date
September 30, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Ljubljana

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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Injuries and Disorders, Ankle Injuries and Disorders, Low Back Pain

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Functional training
Arm Type
Experimental
Arm Description
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.
Arm Title
Regular army training
Arm Type
No Intervention
Arm Description
Regular military training.
Intervention Type
Other
Intervention Name(s)
Exercise
Intervention Description
neuromuscular training
Primary Outcome Measure Information:
Title
Number of Soldiers With Ankle and Knee Injuries
Description
Percentage of soldiers with ankle and knee injuries during the study period.
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Vertical Jump Performance
Description
jump height in countermovement jump
Time Frame
15 weeks
Title
Pull-ups Performance
Description
number of overhand pull-ups in one minute
Time Frame
15 weeks
Title
Hamstring Repetitive Strength
Description
Number of single leg raises on the 60 cm box
Time Frame
15 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
University in Ljubljana
City
Ljubljana
ZIP/Postal Code
1000
Country
Slovenia

12. IPD Sharing Statement

Citations:
PubMed Identifier
29982738
Citation
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.
Results Reference
background
PubMed Identifier
32487675
Citation
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.
Results Reference
result
PubMed Identifier
31800475
Citation
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.
Results Reference
result
PubMed Identifier
34493610
Citation
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. 2023 Oct;169(5):391-396. doi: 10.1136/bmjmilitary-2021-001899. Epub 2021 Sep 7.
Results Reference
result

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Prevention of Musculoskeletal Injuries in Slovenian Armed Forces

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