Evaluation of Physical Fitness and Hemodynamics Across a Diverse Population

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity of Ljubljana

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Adults (18 + years of age) without restriction on sex, health status or physical fitness.

Disqualifiers

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 population

We plan to recruit adults (18 + years of age), without restrictions on sex, health status, or physical fitness level.

Trial design

Design model

Other

Time perspective

Cross-sectional

Treatments tested in this trial

Not listed

Trial groups

30 Participants
are grouped into 2 trial groups
Group A: Asymptomatic individuals - apparently healthy
Group B: Symptomatic individuals

Trial outcomes

Primary outcomes

1

Aerobic capacity (Vo2max-CPET)

Aerobic capacity will be assessed using cardiopulmonary exercise test on a treadmill. Unit of measure (ml/kg/min)

Time frame
Baseline
2

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)

Time frame
Baseline
3

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)

Time frame
Baseline

Secondary outcomes

1

Stiffness of brachial artery

Brachial artery stiffness measured by pulse wave velocity

Time frame
Baseline
2

Flow-mediated slowing (FMS) of brachial artery

Flow-mediated slowing (FMS) of brachial artery measured by Vicorder device

Time frame
Baseline
3

Brachial artery pulse wave analysis

Brachial artery pulse wave analysis will be assessed using the Vicorder device.

Time frame
Baseline
4

Carotid - femoral (cfPWV) arterial stiffness

cfPWV measured by pulse wave velocity

Time frame
Baseline

Other outcomes

1

Sit-to-stand performance

The sit-to-stand test will be used to assess lower extremity physical performance

Time frame
Baseline
2

Push-ups

Push-ups will be used to assess upper body physical performance

Time frame
Baseline

Sponsors and contacts

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