NCT03415464

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
160

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2017

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

January 8, 2018

Completed
22 days until next milestone

First Posted

Study publicly available on registry

January 30, 2018

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2018

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2018

Completed
4.4 years until next milestone

Results Posted

Study results publicly available

February 23, 2023

Completed
Last Updated

February 23, 2023

Status Verified

February 1, 2023

Enrollment Period

1.6 years

First QC Date

January 8, 2018

Results QC Date

May 3, 2020

Last Update Submit

February 21, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • Number of Soldiers With Ankle and Knee Injuries

    Percentage of soldiers with ankle and knee injuries during the study period.

    1 year

Secondary Outcomes (3)

  • Vertical Jump Performance

    15 weeks

  • Pull-ups Performance

    15 weeks

  • Hamstring Repetitive Strength

    15 weeks

Study Arms (2)

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.

Other: Exercise

Regular army training

NO INTERVENTION

Regular military training.

Interventions

neuromuscular training

Functional training

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University in Ljubljana

Ljubljana, 1000, Slovenia

Location

Related Publications (4)

  • 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.

    PMID: 29982738BACKGROUND
  • 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. 2023 Oct;169(5):391-396. doi: 10.1136/bmjmilitary-2021-001899. Epub 2021 Sep 7.

MeSH Terms

Conditions

Knee InjuriesDiseaseAnkle InjuriesLow Back Pain

Interventions

Exercise

Condition Hierarchy (Ancestors)

Leg InjuriesWounds and InjuriesPathologic ProcessesPathological Conditions, Signs and SymptomsBack PainPainNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Results Point of Contact

Title
Vedran Hadzic
Organization
FACULTY OF SPORT

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of the Sports Medicine Department, Faculty of Sport

Study Record Dates

First Submitted

January 8, 2018

First Posted

January 30, 2018

Study Start

January 1, 2017

Primary Completion

July 30, 2018

Study Completion

September 30, 2018

Last Updated

February 23, 2023

Results First Posted

February 23, 2023

Record last verified: 2023-02

Locations