Physical FitnessEPCPSAF-2021NCT05216146
Enhancement of Physical and Combat Preparedness of SAF Members
A study testing Strength and Conditioning in people with Physical Fitness and Combat Readiness, run by University of Ljubljana at 1 site in Slovenia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Physical Fitness, Combat Readiness, Injury Prevention
- What is being tested?
- Strength and Conditioning
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 856 participants
- Where
- 1 siteSlovenia
- Study dates
- 17 Nov 2022to 31 Oct 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Members of Slovenian Armed Forces with no acute and/or chronic neuromuscular and skeletal injuries and/or any other chronic disease or conditions.
Who cannot join
- older than 45 years of age
- acute and/or chronic neuromuscular and skeletal injuries
- the existence of any chronic disease or condition
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Being tested
- Strength and Conditioning
- Keywords
- Slovenian Army, Physical Fitness, Combat Preparedness, Strength and Conditioning practice, Health, Injury prevention, Validation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Strength and ConditioningOther
Also called Strength and Conditioning programme
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.
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | Specially designed program for physical fitness enhancement Receives: Other: Strength and Conditioning |
| Control | Active comparator | A regular program of physical exercise Receives: Other: Strength and Conditioning |
What is being measured
The primary outcome is the main question the study is designed to answer.
Army Combat Fitness Test (ACFT)
ACFT is testing battery used for the evaluation of physical and combat qualities of armed forces
Measured: 75 minutes
Marine Corps Combat Fitness Test (MCCFT)
MCCFT is testing battery used for the evaluation of combat qualities of armed forces
Measured: 4 minutes
Secondary outcomes (3)
Injury occurrence
Injury occurrence evaluation
Measured: 5 minutes
D2 test
Test of attention
Measured: 5 minutes
Stroop test
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.
Measured: 2 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2022
- Study start17 Nov 2022
- Primary completion1 May 2023
- Study completion31 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Physical FitnessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized controlled trial
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 856 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Ljubljana
- Sponsor type
- University, hospital or other
- Collaborators
- Science and Research Centre Koper
- Responsible party
- Principal investigator, Armin Paravlic, University of Ljubljana
- Investigators
- Janez Paravlic, PhD, Study director, Faculty of SportArmin Paravlic, PhD, Principal investigator, Faculty of Sport and Science and Research Centre Koper
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05216146
- Sponsor's protocol ID
- 0120-495/2021/6
- Acronym
- EPCPSAF-2021
- Status last verified
- Nov 2024
- First submitted
- 18 Jan 2022
- Last updated
- 18 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhancement of Physical and Combat Preparedness of the Slovenian Armed Forces Members
- ClinicalTrials.gov ID
- NCT05216146
- Acronym / sponsor ID
- EPCPSAF-2021 / 0120-495/2021/6
- Keywords
- Slovenian Army, Physical Fitness, Combat Preparedness, Strength and Conditioning practice, Health, Injury prevention, Validation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 856 participants (actual)
- Lead sponsor
- University of LjubljanaUniversity, hospital or other
- Collaborators
- Science and Research Centre Koper
- Study start
- 17 Nov 2022 (actual)
- Primary completion
- 1 May 2023 (actual)
- Study completion
- 31 Oct 2023 (actual)
- First posted
- 31 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Other: Strength and ConditioningSpecially designed program for physical fitness enhancement |
| Control | Active comparator | Other: Strength and ConditioningA regular program of physical exercise |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Members of Slovenian Armed Forces with no acute and/or chronic neuromuscular and skeletal injuries and/or any other chronic disease or conditions.
Key exclusion criteria (3 listed)
- older than 45 years of age
- acute and/or chronic neuromuscular and skeletal injuries
- the existence of any chronic disease or condition
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Strength and ConditioningAlso: Strength and Conditioning programmeA 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 | Control, Experimental |
Primary outcome
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
Marine Corps Combat Fitness Test (MCCFT)
Time frame: 4 minutes
MCCFT is testing battery used for the evaluation of combat qualities of armed forces
3 secondary outcomes
Injury occurrence
Time frame: 5 minutes
D2 test
Time frame: 5 minutes
Stroop test
Time frame: 2 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2024.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Janez Paravlic, PhD study director
Faculty of Sport
Armin Paravlic, PhD principal investigator
Faculty of Sport and Science and Research Centre Koper
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Strength and Conditioning in people with Physical Fitness and Combat Readiness, run by University of Ljubljana at 1 site in Slovenia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Slovenia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Army Combat Fitness Test (ACFT) (time frame: 75 minutes). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2024.