- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05216146
Enhancement of Physical and Combat Preparedness of SAF Members (EPCPSAF-2021)
January 9, 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
Completed
Intervention / Treatment
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
Interventional
Enrollment (Actual)
856
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 Contact
- Name: Janez Vodicar, PhD
- Phone Number: 00386015207842
- Email: janez.vodicar@fsp.uni-lj.si
Study Contact Backup
- Name: Armin Paravlic, PhD
- Phone Number: 00386015207842
- Email: armin.paravlic@hotmail.com
Study Locations
-
-
-
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
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 |
Intervention / Treatment |
---|---|
Experimental: Experimental
Specially designed program for physical fitness enhancement
|
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:
|
Active Comparator: Control
A regular program of physical exercise
|
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:
|
What is the study measuring?
Primary Outcome Measures
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
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
Collaborators
Investigators
- 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)
November 17, 2022
Primary Completion (Actual)
May 1, 2023
Study Completion (Actual)
October 31, 2023
Study Registration Dates
First Submitted
January 18, 2022
First Submitted That Met QC Criteria
January 18, 2022
First Posted (Actual)
January 31, 2022
Study Record Updates
Last Update Posted (Actual)
January 10, 2024
Last Update Submitted That Met QC Criteria
January 9, 2024
Last Verified
January 1, 2024
More Information
Terms related to this study
Keywords
Other Study ID 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
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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