Prehypertension (Elevated Blood Pressure) or HypertensionACT-ON-s1NCT06669715
Evaluation of Physical Fitness and Hemodynamics Across a Diverse Population
An observational study of Prehypertension (Elevated Blood Pressure) or Hypertension and Obesity and Obesity-related Medical Conditions, run by University of Ljubljana at 1 site in Slovenia.
Trial summary
In this study, investigators will use the IFT 30-15 test, a six-minute walking test, and a treadmill test to assess the participants' cardiorespiratory fitness. For the treadmill cardiopulmonary exercise test (CPET), we will measure indirect gas exchange using a CPET device (K5). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Prehypertension (Elevated Blood Pressure) or Hypertension, Obesity and Obesity-related Medical Conditions
- How many people
- 30 participants
- Where
- 1 siteSlovenia
- Study dates
- 4 Nov 2024to 30 Oct 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: We plan to recruit adults (18 + years of age), without restrictions on sex, health status, or physical fitness level.
Who may be able to join
- Adults (18 + years of age) without restriction on sex, health status or physical fitness.
Who cannot join
- Inability to walk without assistance
- Presence of acute injuries and/or illnesses that limit maximal exertion during physical fitness testing
- Lower extremity injury or surgery within the past 2 years (if not fully rehabilitated)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Kristina Drole, MSc contact
Slovenia1 site, 1 recruiting
- Recruiting
Faculty of Sport, University of Ljubljana
Ljubljana, 1000
Armin Paravlic, PhD, +386015207840, armin.paravlic@fsp.uni-lj.si
Armin Paravlic, PhD
About this study
Official title: Validation of an Interval Test for Monitoring Cardiovascular Function for Individuals With Different Levels of Physical Fitness
In this study, investigators will use the IFT 30-15 test, a six-minute walking test, and a treadmill test to assess the participants' cardiorespiratory fitness. For the treadmill cardiopulmonary exercise test (CPET), we will measure indirect gas exchange using a CPET device (K5). Maximum heart rate (HRmax) will be measured with a Polar heart rate monitor (model H10). The six-minute walking test will follow standardized procedures, and the treadmill test will follow a protocol of gradually increasing speed each minute.
The study will involve two groups of participants: healthy individuals and pre-hypertensive individuals. While the IFT 30-15 test has been validated on a diverse range of athletes and physically active individuals, it has not yet been validated in individuals with similar characteristics to our participants (BMI > 30 and limited cardiovascular function). Additionally, a variety of hemodynamic measures and other physical function measures such as sit-to-stand and push-ups will be assessed for all participants.
Read the detailed description
Study description This study is a work package of the ACT-ON project, aimed at validating different physical fitness assessment tests in diverse populations considering their health status. Thus, in the proposed study we will assess the potential for validating a selected cardiovascular function test for individuals with varying levels of physical fitness. The chosen test, the Intermittent Fitness Test 30-15 (hereafter referred to as IFT 30-15), is a field test commonly used to measure or determine aerobic capacities. More specifically, IFT 30-15 allows for the assessment of maximum oxygen uptake (VO2max), maximum heart rate (HRmax), as well as anaerobic capacity and capacity for intermittent high-intensity running. Of particular importance to us is the test's high potential to determine VO2max and HRmax, which consequently allows for defining workloads in specific training zones.
To collect the necessary data, the investigators will use a range of instruments and tools in all planned studies in the following order:
Upon arrival at the laboratory of the Institute of Sport at the Faculty of Sport, the investigators will measure participants' basic anthropometric characteristics and body composition. the investigators will use a stadiometer and anthropometer (GPM, Model 101, Switzerland) to measure height, and body mass will be measured using a multi-frequency bioelectrical impedance device (InBody 720: Biospace, Korea). Blood pressure will then be measured using the Omron M6 device.
Hemodynamics
Pulse Wave Velocity (PWV) Characteristics
The Vicorder device (software version 4; Skidmore Medical, United Kingdom) will be used to measure pulse wave characteristics (PWA) of the brachial artery and pulse wave velocity from the carotid to the femoral artery (cfPWV). This device uses an oscillometric technique to obtain the pulse wave. cfPWV measurements will be taken using a 10 cm cuff around the upper right thigh to detect the femoral pulse and a 3 cm cuff around the neck to detect the right carotid pulse. The neck cuff is designed to be positioned above one carotid artery, avoiding compression of the trachea and both carotid arteries simultaneously. The distance between the suprasternal notch and the cuff on the upper thigh will be measured according to the manufacturer's instructions. Both cuffs will automatically inflate simultaneously to 65 mmHg, with pulse waves recorded in 3 to 5-second intervals while the participant lies in a supine position.
Flow-Mediated Slowing (FMS)
The VICORDER® EndoCheck FMS model was used for FMS determination. Testing was conducted following the device instructions. The pulse wave velocity (PWV) on the upper arm was measured simultaneously between the wrist and upper part of the right arm over 10 minutes, with a 5-minute flow occlusion period. FMS was determined by continuously measuring the minimal PWV compared to the baseline PWV, with the percentage change designated as FMS.
Physical Performance
Maximal Aerobic Capacity
Equipment for Testing Maximal Aerobic Capacity To obtain physiological parameters, the investigators will use a portable gas analyzer K5 (COSMED, Italy). The device provides reliable values for oxygen uptake (VO2), carbon dioxide production (VCO2), and pulmonary ventilation (VE) on a breath-by-breath basis. Heart rate will simultaneously be measured with a heart rate monitor chest strap (Polar, model H10, Finland). Data will be recorded in 5-second intervals and automatically analyzed using the original Polar software. Similar methods were used in previous studies.
Incremental Treadmill Test
After 5 minutes of baseline measurements while participants stand on the treadmill (HP Cosmos, Germany), participants will warm up at a running speed of 8 km/h and a constant 1% incline. They will then perform the actual test, running to exhaustion while the running speed gradually increases by 2 km/h each minute. VO2peak will be defined as a plateau in VO2 values (decrease < 2.1 ml/kg/min) despite an increase in workload. If this criterion is not met, participants will undergo an additional test at a constant speed equal to or greater than the maximum speed reached at the end of the incremental test, as recommended. Respiratory gases will be continuously measured for each breath during the test and averaged over 10-second intervals. Similar methods were used in previous studies.
30-15 Incremental Fitness Test (30-15IFT)
The 30-15 Incremental Fitness Test (30-15IFT) will be used as a field tool to assess cardiovascular endurance (CRF). This intermittent, incremental test consists of 30-second runs on the spot, followed by 15-second active recovery periods. Running speed will be set at 8 km/h for the first 30-second interval and then increase by 0.5 km/h for each subsequent 30-second interval. Participants will be required to run back and forth between two lines spaced 40 m apart, at a predefined pace determined by a pre-recorded signal. This signal allows participants to adjust their running speed as they enter a 3-meter zone in the middle and at each end of the test field. During the 15-second recovery periods, participants will walk to the nearest line (either in the middle or at the end of the running area, depending on where they finished the previous run), and start the next running phase from this line. Participants will be encouraged to complete as many stages as possible. The test will conclude when the participant can no longer maintain the required running speed or if they fail to reach the 3-meter zone three consecutive times before the beep. The speed of the last successfully completed stage will be recorded as the test result, i.e., the minimal running speed (MRS) during the 30-15IFT (MRS IFT). Similar methods were used in previous studies.
Maximal Aerobic Capacity (VO2max) Using the IFT 30-15 Test
The investigators will measure or determine VO2max indirectly using the following formula:
VO2 max (ml.kg-1.min-1) = 28.3 - (2.15 x S) - (0.741 x L) - (0.0357 x TT) + (0.0586 x L x VIFT) + (1.03 x VIFT) S = gender (male=1, female=2) L = age in years TT = body weight in kilograms VIFT = final speed achieved
6-Minute Walk Test (6MWT)
The protocol for the 6-Minute Walk Test (6MWT) was developed following the American Thoracic Society guidelines (2002). The investigators will check for any contraindications among participants, then ask them to walk as far as they can without running along a 40-meter hallway. If a participant stops walking before the 6 minutes have elapsed (or if the test administrator judges that they should not continue), the reason for stopping will be recorded. Test results will be expressed as the walking distance (i.e., 6MWD) in meters.
Sit-to-stand and Push-ups
- Conditions
- Prehypertension (Elevated Blood Pressure) or Hypertension, Obesity and Obesity-related Medical Conditions
- Keywords
- cardiovascular fitness, CRF, physical fitness testing, vascular function, heamodynamics, blood pressure, prehypertension, aerobic capacity, arterial stiffness, endothelial function, post-occlusive reactive hyperemia, PORH
- Medical subject headings
- Prehypertension, Hypertension, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Asymptomatic individuals - apparently healthy | Asymptomatic individuals - apparently healthy | |
| Symptomatic individuals | Symptomatic individuals - prehypertensive and hypertensive individuals |
What is being measured
The primary outcome is the main question the study is designed to answer.
Aerobic capacity (Vo2max-CPET)
Aerobic capacity will be assessed using cardiopulmonary exercise test on a treadmill. Unit of measure (ml/kg/min)
Measured: Baseline
Aerobic capacity (Vo2max-IFT)
Aerobic capacity will be assessed using 30-15 intermittent fitness test. Unit of measure Vo2max derived from the maximal running velocity at the final stage of the test (ml/kg/min)
Measured: Baseline
Aerobic capacity (Vo2max-6MWT)
Aerobic capacity will be assessed using 6-minute walk test. Unit of measure - Vo2max derived from the maximal walking distance achieved on the text (ml/kg/min)
Measured: Baseline
Secondary outcomes (4)
Stiffness of brachial artery
Brachial artery stiffness measured by pulse wave velocity
Measured: Baseline
Flow-mediated slowing (FMS) of brachial artery
Flow-mediated slowing (FMS) of brachial artery measured by Vicorder device
Measured: Baseline
Brachial artery pulse wave analysis
Brachial artery pulse wave analysis will be assessed using the Vicorder device.
Measured: Baseline
Carotid - femoral (cfPWV) arterial stiffness
cfPWV measured by pulse wave velocity
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2024
- Study start4 Nov 2024
- Primary completion1 May 2027 (estimated)
- Study completion30 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prehypertension (Elevated Blood Pressure) or HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Ljubljana
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Armin Paravlic, University of Ljubljana
- Investigators
- Armin Paravlic, PhD, Principal investigator, Faculty of Sport, University of Ljubljana
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06669715
- Sponsor's protocol ID
- ACT-ON
- Other IDs
- 802-15/2023-5, 005-1/2023
- Acronym
- ACT-ON-s1
- Status last verified
- May 2026
- First submitted
- 28 Oct 2024
- Last updated
- 12 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of an Interval Test for Monitoring Cardiovascular Function for Individuals With Different Levels of Physical Fitness
- ClinicalTrials.gov ID
- NCT06669715
- Acronym / sponsor ID
- ACT-ON-s1 / ACT-ON
- Conditions
- Prehypertension (Elevated Blood Pressure) or Hypertension, Obesity and Obesity-related Medical Conditions
- Keywords
- cardiovascular fitness, CRF, physical fitness testing, vascular function, heamodynamics, blood pressure, prehypertension, aerobic capacity
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of LjubljanaUniversity, hospital or other
- Study start
- 4 Nov 2024 (actual)
- Primary completion
- 1 May 2027 (estimated)
- Study completion
- 30 Oct 2027 (estimated)
- First posted
- 1 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In this study, investigators will use the IFT 30-15 test, a six-minute walking test, and a treadmill test to assess the participants' cardiorespiratory fitness. For the treadmill cardiopulmonary exercise test (CPET), we will measure indirect gas exchange using a CPET device (K5). Maximum heart rate (HRmax) will be measured with a Polar heart rate monitor (model H10). The six-minute walking test will follow standardized procedures, and the treadmill test will follow a protocol of gradually increasing speed each minute.
The study will involve two groups of participants: healthy individuals and pre-hypertensive individuals. While the IFT 30-15 test has been validated on a diverse range of athletes and physically active individuals, it has not yet been validated in individuals with similar characteristics to our participants (BMI > 30 and limited cardiovascular function). Additionally, a variety of hemodynamic measures and other physical function measures such as sit-to-stand and push-ups will be assessed for all participants.
Detailed description
Study description This study is a work package of the ACT-ON project, aimed at validating different physical fitness assessment tests in diverse populations considering their health status. Thus, in the proposed study we will assess the potential for validating a selected cardiovascular function test for individuals with varying levels of physical fitness. The chosen test, the Intermittent Fitness Test 30-15 (hereafter referred to as IFT 30-15), is a field test commonly used to measure or determine aerobic capacities. More specifically, IFT 30-15 allows for the assessment of maximum oxygen uptake (VO2max), maximum heart rate (HRmax), as well as anaerobic capacity and capacity for intermittent high-intensity running. Of particular importance to us is the test's high potential to determine VO2max and HRmax, which consequently allows for defining workloads in specific training zones.
To collect the necessary data, the investigators will use a range of instruments and tools in all planned studies in the following order:
Upon arrival at the laboratory of the Institute of Sport at the Faculty of Sport, the investigators will measure participants' basic anthropometric characteristics and body composition. the investigators will use a stadiometer and anthropometer (GPM, Model 101, Switzerland) to measure height, and body mass will be measured using a multi-frequency bioelectrical impedance device (InBody 720: Biospace, Korea). Blood pressure will then be measured using the Omron M6 device.
Hemodynamics
Pulse Wave Velocity (PWV) Characteristics
The Vicorder device (software version 4; Skidmore Medical, United Kingdom) will be used to measure pulse wave characteristics (PWA) of the brachial artery and pulse wave velocity from the carotid to the femoral artery (cfPWV). This device uses an oscillometric technique to obtain the pulse wave. cfPWV measurements will be taken using a 10 cm cuff around the upper right thigh to detect the femoral pulse and a 3 cm cuff around the neck to detect the right carotid pulse. The neck cuff is designed to be positioned above one carotid artery, avoiding compression of the trachea and both carotid arteries simultaneously. The distance between the suprasternal notch and the cuff on the upper thigh will be measured according to the manufacturer's instructions. Both cuffs will automatically inflate simultaneously to 65 mmHg, with pulse waves recorded in 3 to 5-second intervals while the participant lies in a supine position.
Flow-Mediated Slowing (FMS)
The VICORDER® EndoCheck FMS model was used for FMS determination. Testing was conducted following the device instructions. The pulse wave velocity (PWV) on the upper arm was measured simultaneously between the wrist and upper part of the right arm over 10 minutes, with a 5-minute flow occlusion period. FMS was determined by continuously measuring the minimal PWV compared to the baseline PWV, with the percentage change designated as FMS.
Physical Performance
Maximal Aerobic Capacity
Equipment for Testing Maximal Aerobic Capacity To obtain physiological parameters, the investigators will use a portable gas analyzer K5 (COSMED, Italy). The device provides reliable values for oxygen uptake (VO2), carbon dioxide production (VCO2), and pulmonary ventilation (VE) on a breath-by-breath basis. Heart rate will simultaneously be measured with a heart rate monitor chest strap (Polar, model H10, Finland). Data will be recorded in 5-second intervals and automatically analyzed using the original Polar software. Similar methods were used in previous studies.
Incremental Treadmill Test
After 5 minutes of baseline measurements while participants stand on the treadmill (HP Cosmos, Germany), participants will warm up at a running speed of 8 km/h and a constant 1% incline. They will then perform the actual test, running to exhaustion while the running speed gradually increases by 2 km/h each minute. VO2peak will be defined as a plateau in VO2 values (decrease < 2.1 ml/kg/min) despite an increase in workload. If this criterion is not met, participants will undergo an additional test at a constant speed equal to or greater than the maximum speed reached at the end of the incremental test, as recommended. Respiratory gases will be continuously measured for each breath during the test and averaged over 10-second intervals. Similar methods were used in previous studies.
30-15 Incremental Fitness Test (30-15IFT)
The 30-15 Incremental Fitness Test (30-15IFT) will be used as a field tool to assess cardiovascular endurance (CRF). This intermittent, incremental test consists of 30-second runs on the spot, followed by 15-second active recovery periods. Running speed will be set at 8 km/h for the first 30-second interval and then increase by 0.5 km/h for each subsequent 30-second interval. Participants will be required to run back and forth between two lines spaced 40 m apart, at a predefined pace determined by a pre-recorded signal. This signal allows participants to adjust their running speed as they enter a 3-meter zone in the middle and at each end of the test field. During the 15-second recovery periods, participants will walk to the nearest line (either in the middle or at the end of the running area, depending on where they finished the previous run), and start the next running phase from this line. Participants will be encouraged to complete as many stages as possible. The test will conclude when the participant can no longer maintain the required running speed or if they fail to reach the 3-meter zone three consecutive times before the beep. The speed of the last successfully completed stage will be recorded as the test result, i.e., the minimal running speed (MRS) during the 30-15IFT (MRS IFT). Similar methods were used in previous studies.
Maximal Aerobic Capacity (VO2max) Using the IFT 30-15 Test
The investigators will measure or determine VO2max indirectly using the following formula:
VO2 max (ml.kg-1.min-1) = 28.3 - (2.15 x S) - (0.741 x L) - (0.0357 x TT) + (0.0586 x L x VIFT) + (1.03 x VIFT) S = gender (male=1, female=2) L = age in years TT = body weight in kilograms VIFT = final speed achieved
6-Minute Walk Test (6MWT)
The protocol for the 6-Minute Walk Test (6MWT) was developed following the American Thoracic Society guidelines (2002). The investigators will check for any contraindications among participants, then ask them to walk as far as they can without running along a 40-meter hallway. If a participant stops walking before the 6 minutes have elapsed (or if the test administrator judges that they should not continue), the reason for stopping will be recorded. Test results will be expressed as the walking distance (i.e., 6MWD) in meters.
Sit-to-stand and Push-ups
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Asymptomatic individuals - apparently healthy | – | –Asymptomatic individuals - apparently healthy |
| Symptomatic individuals | – | –Symptomatic individuals - prehypertensive and hypertensive individuals |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- We plan to recruit adults (18 + years of age), without restrictions on sex, health status, or physical fitness level.
Key inclusion criteria (1 listed)
- Adults (18 + years of age) without restriction on sex, health status or physical fitness.
Key exclusion criteria (3 listed)
- Inability to walk without assistance
- Presence of acute injuries and/or illnesses that limit maximal exertion during physical fitness testing
- Lower extremity injury or surgery within the past 2 years (if not fully rehabilitated)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Aerobic capacity (Vo2max-CPET)
Time frame: Baseline
Aerobic capacity will be assessed using cardiopulmonary exercise test on a treadmill. Unit of measure (ml/kg/min)
Aerobic capacity (Vo2max-IFT)
Time frame: Baseline
Aerobic capacity will be assessed using 30-15 intermittent fitness test. Unit of measure Vo2max derived from the maximal running velocity at the final stage of the test (ml/kg/min)
Aerobic capacity (Vo2max-6MWT)
Time frame: Baseline
Aerobic capacity will be assessed using 6-minute walk test. Unit of measure - Vo2max derived from the maximal walking distance achieved on the text (ml/kg/min)
4 secondary outcomes
Stiffness of brachial artery
Time frame: Baseline
Flow-mediated slowing (FMS) of brachial artery
Time frame: Baseline
Brachial artery pulse wave analysis
Time frame: Baseline
Carotid - femoral (cfPWV) arterial stiffness
Time frame: Baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Kristina Drole, MSc contact
Armin Paravlic, PhD principal investigator
Faculty of Sport, University of Ljubljana
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Prehypertension (Elevated Blood Pressure) or Hypertension and Obesity and Obesity-related Medical Conditions, 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 3 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: looking for participants now, as of the sponsor's last update on 12 May 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Armin H Researcher, PhD (+386015207840, armin.paravlic@fsp.uni-lj.si), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Aerobic capacity (Vo2max-CPET) (time frame: Baseline). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 May 2026.