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

January 9, 2024 updated by: Armin Paravlic, University of Ljubljana

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

34

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 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

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: Screening
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

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
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

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
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

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
Active Comparator: 30-15 Intermittent Fitness Test - second trial
The procedures will be the same as previously described
Diagnostic test: Cardio 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Maxima Oxygen Consumption (Vo2max)
Time Frame: 30 minutes
Measure of maximal aerobic capacity (Vo2max)
30 minutes

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Maximal Running Speed
Time Frame: 30 minutes
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
30 minutes
Tensiomyography (TMG)
Time Frame: 10 minutes
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.
10 minutes
Jumping ability
Time Frame: 10 minutes
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.
10 minutes
D2 test
Time Frame: 5 minutes
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.
5 minutes

Collaborators and Investigators

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

Sponsor

University of Ljubljana

Collaborators

Science and Research Centre Koper

Investigators

  • Study Director: Janez Vodicar, Faculty of Sport
  • Principal Investigator: Armin Paravlic, Faculty of Sport and Science and Research Centre Koper

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

February 14, 2022

Primary Completion (Actual)

June 1, 2022

Study Completion (Actual)

June 1, 2022

Study Registration Dates

First Submitted

January 19, 2022

First Submitted That Met QC Criteria

January 19, 2022

First Posted (Actual)

February 1, 2022

Study Record Updates

Last Update Posted (Actual)

January 11, 2024

Last Update Submitted That Met QC Criteria

January 9, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • EPCPSAF-2021-22-validation

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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