CClinicalTrials.gg
CompletedNCT05218798EPCPSAF-2021Updated Jan 11, 2024

Enhancement of Physical and Combat Preparedness of SAF Members - Validation Study

An interventional study of Cardio Respiratory Fitness testing in Physical Fitness, Cardio Respiratory Fitness and Aerobic Capacity, sponsored by University of Ljubljana. Completed at 1 site in Slovenia. Open to participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-01-11.

Sponsored by University of Ljubljana · Not applicable, Interventional, and Screening

Phase
Not applicable
Study type
Interventional
Enrollment
34
Allocation
Randomized
Ages
18 Years to 45 Years
Sex
All
01

Study summary

The aim of the proposed project is to investigate the reliability, validity, and usefulness of the 30-15 intermittent fitness test in the Slovenian Armed Forces. We will compare the results obtained from a continuous treadmill running test, 2-mile run test, and 30-15IFT.

Read the detailed description

Since the ability to perform military tasks depends on the physical fitness of soldiers (PF), one of the most commonly measured PF components during routine physical examinations is cardiorespiratory fitness (CRF). There are several tests used to measure CRF in the armed forces. Because of its simplicity, the most commonly used test of CRF is the 2-mile run test, but it has its own limitations when it comes to specificity of battlefield requirements, training prescription and optimization, and estimation of Vo2max. In combat situations, soldiers rarely run long distances on the battlefield. Therefore, the 2-mile run test does not appear to represent any specificity of combat. Furthermore, based on the data collected from this test, it is difficult to prescribe and optimize a training program for an individual subject. Therefore, the goal of the proposed project is to investigate the reliability, validity, and usefulness of the 30-15 intermittent fitness test in the Slovenian Armed Forces.

02

Conditions studied

  • Physical Fitness
  • Cardio Respiratory Fitness
  • Aerobic Capacity
  • Physical Examination
  • Combat Preparedness
03

In context

Lead sponsor

University of Ljubljana is the lead sponsor of 42 studies on the registry; 12 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

Exclusion Criteria:

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

05

Study design

Phase
Not applicable
Primary purpose
Screening
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
34 participants (actual)

Study arms

  • Active comparator
    Continous Treadmill Running Test

    One of the four testing conditions the subject will be allocated to is a Continous Treadmill Running Test. Vo2max will be measured by using A K4 b2 a portable gas analyzer (COSMED, Italy). The device provides reliable values for oxygen uptake (VO2), carbon dioxide production (VCO2), and pulmonary ventilation (VE) breath by breath. In addition, blood samples (20 μL) were collected from the earlobe for both tests (before, immediately after, 3 min after, and 5 min after the test) and the samples will be analyzed for blood lactate concentration (\[LA-\]).

    Diagnostic Test: Cardio Respiratory Fitness testing

  • Active comparator
    Continous 2-mile run test

    One of the four testing conditions the subject will be allocated to is a Continous 2-mile run test. Vo2max will be measured by using A K4 b2 a portable gas analyzer (COSMED, Italy). The device provides reliable values for oxygen uptake (VO2), carbon dioxide production (VCO2), and pulmonary ventilation (VE) breath by breath. In addition, blood samples (20 μL) were collected from the earlobe for both tests (before, immediately after, 3 min after, and 5 min after the test) and the samples will be analyzed for blood lactate concentration (\[LA-\]).

    Diagnostic Test: Cardio Respiratory Fitness testing

  • Active comparator
    30-15 Intermittent Fitness Test - first trial

    Aerobic capacity will be measured using the field-based 30-15IFT test. This intermittent, incremental test consists of 30-second shuttle runs interspersed with 15-second active recovery periods. Running speed will be set at 8 km/h for the first 30-second run and increased by 0.5 km/h in each 30-second phase thereafter. The speed of the last successfully completed stage will be recorded as the test result, i.e. the maximum running speed (V) during IFT. Vo2max will be estimated by the following equation: Vo2max IFT (ml/min/kg) = 28.3 - 2.15G - 0.741A - 0.0357BM + 0.058A X VIFT + 1.03VIFT where G stands for subjects gender, A for age and BM for body mass, respectively.

    Diagnostic Test: Cardio Respiratory Fitness testing

  • Active comparator
    30-15 Intermittent Fitness Test - second trial

    The procedures will be the same as previously described

    Diagnostic Test: Cardio Respiratory Fitness testing

Interventions

  • Diagnostic testCardio Respiratory Fitness testing

    In a randomized cross over designed study, we will measure Vo2max by using different tests: 1. Continous Treadmill Running Test 2. Continous 2-mile run test 3. 30-15 Intermittent Fitness Test - first trial and second trial

06

What researchers measure

Primary outcomes

  1. Maxima Oxygen Consumption (Vo2max)

    Measure of maximal aerobic capacity (Vo2max)

    Time frame: 30 minutes

Secondary outcomes

  1. Maximal Running Speed

    Maximal running speed achieved during different Vo2max testing batteries. The speed of the last successfully completed stage will be recorded as the test result, i.e. the maximum running speed (V) during IFT, or the last running speed reached during a continuous test will be defined as VTR

    Time frame: 30 minutes

  2. Tensiomyography (TMG)

    We will use TMG to assess muscle fatigue from pre to post-different Vo2max testing procedures. The contractile properties of the individual muscles will be assessed by the non-invasive TMG method. We will measure knee extensor and flexors muscles of the dominant leg only.

    Time frame: 10 minutes

  3. Jumping ability

    Countermovement and squat jumps will be used to assess muscle fatigue from pre to post-different Vo2max testing procedures. Jumping ability will be assessed by vertical jump tests, using a bilateral force plate (model 9260AA6, Kistler, Switzerland) with Kistler MARS software to record ground reaction force data.

    Time frame: 10 minutes

  4. D2 test

    The D2 Test of Attention is a neuropsychological measure of selective and sustained attention and visual scanning speed. It is a paper and pencil test that asks participants to cross out any letter "d" with two marks around above it or below it in any order.

    Time frame: 5 minutes

  5. 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.

    Time frame: 2 minutes

07

Study locations

1 site
  • Faculty of Sport
    Ljubljana, 1000, Slovenia
08

References and documents

Publications

  • Paravlic AH, Simunic B, Pisot R, Rauter S, Stuhec S, Vodicar J. The reliability, validity and usefulness of the 30-15 intermittent fitness test for cardiorespiratory fitness assessment in military personnel. Sci Rep. 2022 Sep 27;12(1):16087. doi: 10.1038/s41598-022-20315-3. PubMed 36167789 ↗
  • Paravlic AH, Simunic B, Pisot R, Rauter S, Vodicar J. Reliability and validity of 30-15 intermittent fitness test for cardiorespiratory fitness assessment among infantry members of Slovenian armed forces: A study protocol. Front Psychol. 2022 Jul 22;13:894186. doi: 10.3389/fpsyg.2022.894186. eCollection 2022. PubMed 35936328 ↗

Individual participant data

Plan to share: 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.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 11, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05218798
Lead sponsor
University of Ljubljana
Collaborators
Science and Research Centre Koper
Responsible party
Armin Paravlic (Faculty of Sport, University of Ljubljana) — Principal investigator
First posted
Feb 1, 2022
Start date
Feb 14, 2022
Primary completion
Jun 1, 2022
Completion
Jun 1, 2022
Last update
Jan 11, 2024

Study contacts

Janez Vodicar
study director · Faculty of Sport
Armin Paravlic
principal investigator · Faculty of Sport and Science and Research Centre Koper

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jan 2024. You cannot join it, but the record below documents what was studied.

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