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

NCT05218798 | Completed

• 1 other identifier: EPCPSAF-2021-22-validation
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

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.

Conditions

Physical Fitness; Cardio Respiratory Fitness; Aerobic Capacity; Physical Examination; Combat Preparedness

Outcome Measures

Primary Outcomes (1)

• Maxima Oxygen Consumption (Vo2max)

  Measure of maximal aerobic capacity (Vo2max)

  30 minutes

Secondary Outcomes (5)

• Maximal Running Speed

  30 minutes

• Tensiomyography (TMG)

  10 minutes

• Jumping ability

  10 minutes

• D2 test

  5 minutes

• Stroop test

  2 minutes

Study Arms (4)

Continous Treadmill Running Test

ACTIVE COMPARATOR

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

Continous 2-mile run test

ACTIVE COMPARATOR

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

30-15 Intermittent Fitness Test - first trial

ACTIVE COMPARATOR

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

30-15 Intermittent Fitness Test - second trial

ACTIVE COMPARATOR

The procedures will be the same as previously described

Diagnostic Test: Cardio Respiratory Fitness testing

Interventions

Cardio Respiratory Fitness testing DIAGNOSTIC_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

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

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Members of Slovenian Armed Forces with no acute and/or chronic neuromuscular and skeletal injuries and/or any other chronic disease or conditions.

You may not qualify if:

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

Sponsors & Collaborators

• University of Ljubljana: lead
• Science and Research Centre Koper: collaborator

Study Sites (1)

Faculty of Sport

Ljubljana, 1000, Slovenia

Location

Related Publications (2)

• 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.

  PMID: 36167789 RESULT

• 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.

  PMID: 35936328 DERIVED

Study Officials

• Janez Vodicar

  Faculty of Sport

  STUDY DIRECTOR

• Armin Paravlic

  Faculty of Sport and Science and Research Centre Koper

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: All subjects will be blinded for group allocation during testing procedures, including coaches (care provider), soldiers (participants) investigators, and outcomes assessors.
• Purpose: SCREENING
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Faculty of Sport

Model Details: Crossover randomized validation study

Study Record Dates

• First Submitted: January 19, 2022
• First Posted: February 1, 2022
• Study Start: February 14, 2022
• Primary Completion: June 1, 2022
• Study Completion: June 1, 2022
• Last Updated: January 11, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

SL (1)