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Physical FitnessEPCPSAF-2021NCT05218798

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

A study testing Cardio Respiratory Fitness testing in people with Physical Fitness and Cardio Respiratory Fitness, run by University of Ljubljana at 1 site in Slovenia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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 more about this study

Who is it for?
Ages 18 to 45 yearsHealthy volunteers can take part
What is being tested?
Cardio Respiratory Fitness testing
Could I receive a placebo?
No, everyone receives an active treatment
How many people
34 participants
Where
1 siteSlovenia
Study dates
14 Feb 2022to 1 Jun 2022
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.

Slovenia1 site

  • Faculty of Sport

    Ljubljana, 1000

Other trials in Slovenia

About this study

Official title: Comparison of the Different Tests Used to Measure Maximal Aerobic Capacity Among Slovenian Armed Forces

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.

Being tested
Cardio Respiratory Fitness testing

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Cardio Respiratory Fitness testingDiagnostic test

    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
Study groups in NCT05218798
Study groupRoleWhat they receive
Continous Treadmill Running TestActive comparatorOne 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-]).
Receives: Diagnostic Test: Cardio Respiratory Fitness testing
Continous 2-mile run testActive comparatorOne 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-]).
Receives: Diagnostic Test: Cardio Respiratory Fitness testing
30-15 Intermittent Fitness Test - first trialActive comparatorAerobic 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.
Receives: Diagnostic Test: Cardio Respiratory Fitness testing
30-15 Intermittent Fitness Test - second trialActive comparatorThe procedures will be the same as previously described
Receives: Diagnostic Test: Cardio Respiratory Fitness testing

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Maxima Oxygen Consumption (Vo2max)

    Measure of maximal aerobic capacity (Vo2max)

    Measured: 30 minutes

Secondary outcomes (5)

  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

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 2 minutes

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Feb 2022
  2. Study start14 Feb 2022
  3. Primary completion1 Jun 2022
  4. Study completion1 Jun 2022

Resources

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
Screening
Allocation
Randomised
Intervention model
Crossover
Model description
Crossover randomized validation study
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
34 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05218798
Sponsor's protocol ID
EPCPSAF-2021-22-validation
Acronym
EPCPSAF-2021
Status last verified
Jan 2024
First submitted
19 Jan 2022
Last updated
11 Jan 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.

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

Questions about this trial

What is this clinical trial studying?

A study testing Cardio Respiratory Fitness testing in people with Physical Fitness and Cardio Respiratory Fitness, 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 1 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 11 Jan 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?

Maxima Oxygen Consumption (Vo2max) (time frame: 30 minutes). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05218798, which also lists 2 linked publications.

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 11 Jan 2024.

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