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

Sponsor
University of Ljubljana (Other)
Overall Status
Recruiting
CT.gov ID
NCT05218798
Collaborator
Science and Research Centre Koper (Other)
30
1
4
9.5
3.1

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: Cardio Respiratory Fitness testing
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
30 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Intervention Model Description:
Crossover randomized validation studyCrossover randomized validation study
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description:
All subjects will be blinded for group allocation during testing procedures, including coaches (care provider), soldiers (participants) investigators, and outcomes assessors.
Primary Purpose:
Screening
Official Title:
Comparison of the Different Tests Used to Measure Maximal Aerobic Capacity Among Slovenian Armed Forces
Actual Study Start Date :
Feb 14, 2022
Actual Primary Completion Date :
Jul 1, 2022
Anticipated Study Completion Date :
Dec 1, 2022

Arms and Interventions

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: Continous Treadmill Running Test Continous 2-mile run test 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: Continous Treadmill Running Test Continous 2-mile run test 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: Continous Treadmill Running Test Continous 2-mile run test 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: Continous Treadmill Running Test Continous 2-mile run test 30-15 Intermittent Fitness Test - first trial and second trial

Outcome Measures

Primary Outcome Measures

  1. Maxima Oxygen Consumption (Vo2max) [30 minutes]

    Measure of maximal aerobic capacity (Vo2max)

Secondary Outcome Measures

  1. Maximal Running Speed [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

  2. Tensiomyography (TMG) [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.

  3. Jumping ability [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.

  4. D2 test [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. Stroop test [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 45 Years
Sexes Eligible for Study:
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:

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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Faculty of Sport Ljubljana Slovenia 1000

Sponsors and Collaborators

  • University of Ljubljana
  • 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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Armin Paravlic, Faculty of Sport, University of Ljubljana
ClinicalTrials.gov Identifier:
NCT05218798
Other Study ID Numbers:
  • EPCPSAF-2021-22-validation
First Posted:
Feb 1, 2022
Last Update Posted:
Jul 6, 2022
Last Verified:
Jul 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Jul 6, 2022