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临床试验/NCT06669715
NCT06669715招募中不适用

Validation of an Interval Test for Monitoring Cardiovascular Function for Individuals With Different Levels of Physical Fitness

University of Ljubljana2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2024年11月4日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
30
试验地点
2
主要终点
Aerobic capacity (Vo2max-CPET)

研究概览

简要总结

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.

详细描述

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

研究设计

研究类型
Observational
观察模型
Other
时间视角
Cross Sectional

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

  • 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)

结局指标

主要结局

Aerobic capacity (Vo2max-CPET)

时间窗: Baseline

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

Aerobic capacity (Vo2max-IFT)

时间窗: 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)

时间窗: 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)

次要结局

  • Stiffness of brachial artery(Baseline)
  • Flow-mediated slowing (FMS) of brachial artery(Baseline)
  • Brachial artery pulse wave analysis(Baseline)
  • Carotid - femoral (cfPWV) arterial stiffness(Baseline)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Armin Paravlic

Assistant Professor, PhD

University of Ljubljana

研究点 (2)

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