- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05218798
Enhancement of Physical and Combat Preparedness of SAF Members - Validation Study (EPCPSAF-2021)
Comparison of the Different Tests Used to Measure Maximal Aerobic Capacity Among Slovenian Armed Forces
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Ljubljana, Slovenia, 1000
- Faculty of Sport
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
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
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-]).
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In a randomized cross over designed study, we will measure Vo2max by using different tests:
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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-]).
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In a randomized cross over designed study, we will measure Vo2max by using different tests:
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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. |
In a randomized cross over designed study, we will measure Vo2max by using different tests:
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Active Comparator: 30-15 Intermittent Fitness Test - second trial
The procedures will be the same as previously described
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In a randomized cross over designed study, we will measure Vo2max by using different tests:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Maxima Oxygen Consumption (Vo2max)
Time Frame: 30 minutes
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Measure of maximal aerobic capacity (Vo2max)
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30 minutes
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Stroop test
Time Frame: 2 minutes
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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.
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2 minutes
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Maximal Running Speed
Time Frame: 30 minutes
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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
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30 minutes
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Tensiomyography (TMG)
Time Frame: 10 minutes
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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.
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10 minutes
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Jumping ability
Time Frame: 10 minutes
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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.
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10 minutes
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D2 test
Time Frame: 5 minutes
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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.
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5 minutes
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Collaborators and Investigators
Sponsor
Collaborators
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
General 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
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)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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