Clinical Trial

Evaluation of Physical Fitness and Hemodynamics Across a Diverse Population

Study acronym: ACT-ON-s1
Recruiting
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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). 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.
Protocol Amendment History 3 amendments
This ClinicalTrials.gov record has been amended 3 times since 2024-10-30; most recent amendment 2026-05-07.
Status change: Not Yet Recruiting → Recruiting 2024-11-03
Trial Details
NCT Number NCT06669715
Lead Sponsor University of Ljubljana
Conditions Prehypertension (Elevated Blood Pressure) or Hypertension, Obesity and Obesity-related Medical Conditions
Enrollment 30 participants
Start Date 2024-11-04
Primary Completion 2027-05-01 (estimated)
Study Completion 2027-10-30 (estimated)
Updated on ClinicalTrials.gov 2026-05-12