NCT05216146

Brief Summary

Regular and optimal fitness training has a positive effect on reducing risk or injury in addition to enhancing psychophysical and combat skills. On the other hand, excessive fitness training is one of the risk factors for injuries in soldiers. For this reason, it is necessary to establish a new system of the training process and regular monitoring of physical and combat readiness of the SAF with the help of scientific and professional methodology. The proposed research project will run for two years. The main goal of the project is to enhance physical and combat readiness and determine the epidemiology of injuries of members of the Slovenian Armed Forces (SAF). Within this aim, we will also run a validation study aimed to improve existing testing batteries for armed forces.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
856

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2022

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 18, 2022

Completed
13 days until next milestone

First Posted

Study publicly available on registry

January 31, 2022

Completed
10 months until next milestone

Study Start

First participant enrolled

November 17, 2022

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2023

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2023

Completed
Last Updated

November 18, 2024

Status Verified

November 1, 2024

Enrollment Period

6 months

First QC Date

January 18, 2022

Last Update Submit

November 14, 2024

Conditions

Keywords

Slovenian ArmyPhysical FitnessCombat PreparednessStrength and Conditioning practiceHealthInjury preventionValidation

Outcome Measures

Primary Outcomes (2)

  • Army Combat Fitness Test (ACFT)

    ACFT is testing battery used for the evaluation of physical and combat qualities of armed forces

    75 minutes

  • Marine Corps Combat Fitness Test (MCCFT)

    MCCFT is testing battery used for the evaluation of combat qualities of armed forces

    4 minutes

Secondary Outcomes (3)

  • Injury occurrence

    5 minutes

  • D2 test

    5 minutes

  • Stroop test

    2 minutes

Study Arms (2)

Experimental

EXPERIMENTAL

Specially designed program for physical fitness enhancement

Other: Strength and Conditioning

Control

ACTIVE COMPARATOR

A regular program of physical exercise

Other: Strength and Conditioning

Interventions

A specially designed strength and conditioning program will be delivered for a period of 6 months from the experienced strength and conditioning coaches. The program will consist of the basic aerobic and anaerobic exercises that could be practiced without additional equipment and with own body weight.

Also known as: Strength and Conditioning programme
ControlExperimental

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Members of Slovenian Armed Forces with no acute and/or chronic neuromuscular and skeletal injuries and/or any other chronic disease or conditions.

You may not qualify if:

  • older than 45 years of age
  • acute and/or chronic neuromuscular and skeletal injuries
  • the existence of any chronic disease or condition

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Sport

Ljubljana, Slovenia, 1000, Slovenia

Location

Study Officials

  • Janez Paravlic, PhD

    Faculty of Sport

    STUDY DIRECTOR
  • Armin Paravlic, PhD

    Faculty of Sport and Science and Research Centre Koper

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Masking Details
All subjects except the main investigator will be blinded for group allocation and physical training program, including coaches (care provider), soldiers (participants) and outcomes assessors.
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: Randomized controlled trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 18, 2022

First Posted

January 31, 2022

Study Start

November 17, 2022

Primary Completion

May 1, 2023

Study Completion

October 31, 2023

Last Updated

November 18, 2024

Record last verified: 2024-11

Data Sharing

IPD Sharing
Will not share

There is no plan for such an action. However, if the principal investigator and the project sponsor allow this aiming to collaborate on other projects, we will be interested to do so.

Locations