Enhancement of Physical and Combat Preparedness of SAF Members (EPCPSAF-2021)

November 14, 2024 updated by: Armin Paravlic, University of Ljubljana

Enhancement of Physical and Combat Preparedness of the Slovenian Armed Forces Members

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The doctrine of Slovenian Armed Forces defines combat morale, which includes the readiness of the members of the Slovenian Armed Forces, as the greatest physical effort to overcome natural or artificial obstacles that must be overcome in the workplace or battle. Therefore, the military has specific requirements for military service. One of these is combat readiness, with physical fitness being the basis for action at the level of the human body and mind, for those who wish to achieve the skills that enable the exercise required for the professional soldier. From the viewpoint of the individual, no matter if he/she is a soldier or officer, he must be able to withstand the stresses and strains of various situations in the field, even in emergencies. This means that the body must adapt to a given situation, which requires extensive psychophysical preparation for a given situation. The profile of a high-class soldier must meet the criteria of a top athlete who is psychophysically healthy and at the highest level of his abilities when it is most needed. Certainly, there is a direct correlation between a soldier's health and his fitness, individual performance, and professional development. Throughout a career, unhealthy habits inhibit a soldier's development in the operational, self-developmental, and institutional areas of an Army leader's development strategy. 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 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). The results of the planned studies will be used in parallel to develop a mobile application that will facilitate the training process of SAF members and the transfer of knowledge to other interested entities and organizations. According to the project goals set, we will conduct several individual studies. Briefly, Study 1 will be a cross-sectional prospective study with the main aim to conduct an epidemiological screening of injuries and estimate the risk factors, addressing only the most common injuries (≥30 per year). Research 2 will be a longitudinal cross-sectional study in which we intend to validate testing batteries for the physical and combat readiness of SAF members. Research 3 will be a longitudinal intervention study in which we will compare the new strength and conditioning system with the existing system. We will sample adult subjects, i.e. officially employed members of the SAF (18-45 years of age, Study 1-3), of both genders, based on detailed inclusion and exclusion criteria for each study separately. The project will leave an extremely useful trail, such as a mobile application with a series of testing batteries aimed to determine physical and combat readiness, as well as preventive and rehabilitation practices for the most common injuries among SAF members. It should be emphasized that the project is limited to ensuring physical fitness for combat operations. For example, the project does not provide guidelines for the handling of firearms - that is, the accuracy of shooting, but the physical effort required to carry the weapon and prepare it for shooting. We believe that the new training system, supported by a mobile application, will come to life and provide SAF members with a more in-depth and better individualized approach to the training process, allowing individuals to optimally develop their physical and combative readiness, thus achieving greater visibility both domestically and internationally.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
856

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Slovenia
      • Ljubljana, Slovenia, 1000
        • Faculty of Sport

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

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: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Experimental
Specially designed program for physical fitness enhancement
Other: Strength and Conditioning
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.
Other Names:
  • Strength and Conditioning programme
Active Comparator: Control
A regular program of physical exercise
Other: Strength and Conditioning
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.
Other Names:
  • Strength and Conditioning programme

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Army Combat Fitness Test (ACFT)
Time Frame: 75 minutes
ACFT is testing battery used for the evaluation of physical and combat qualities of armed forces
75 minutes
Marine Corps Combat Fitness Test (MCCFT)
Time Frame: 4 minutes
MCCFT is testing battery used for the evaluation of combat qualities of armed forces
4 minutes

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Injury occurrence
Time Frame: 5 minutes
Injury occurrence evaluation
5 minutes
D2 test
Time Frame: 5 minutes
Test of attention
5 minutes
Stroop test
Time Frame: 2 minutes
The stroop is a neuro-psychological test extensively used to assess the ability to inhibit cognitive interference that occurs when the processing of a specific stimulus feature impedes the simultaneous processing of a second stimulus attribute.
2 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Ljubljana

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Science and Research Centre Koper

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Janez Paravlic, PhD, Faculty of Sport
  • Principal Investigator: Armin Paravlic, PhD, Faculty of Sport and Science and Research Centre Koper

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 17, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 1, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 31, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 18, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 18, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 31, 2022

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 18, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 14, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 0120-495/2021/6

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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