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临床试验/NCT07048509
NCT07048509招募中不适用

Difference in Acute Responses of Vascular Function to Moderate-intensity and High-intensity Interval Training in Healthy and Prehypertensive Individuals

University of Ljubljana2 个研究点 分布在 1 个国家目标入组 45 人开始时间: 2025年6月24日最近更新:

试验速览

阶段
不适用
状态
招募中
入组人数
45
试验地点
2
主要终点
Microvascular function

研究概览

简要总结

In this study, the investigators will evaluate acute changes in vascular function measures after moderate-intensity continuous and high-intensity interval exercise in healthy and prehypertensive individuals. Participants will be subjected to three separate visits: control condition (30 min rest), moderate-intensity continuous exercise, and high-intensity interval exercise. The investigators will measure aerobic capacity using a cardiopulmonary exercise test (CPET) using indirect gas-exchange to derive subsequent exercise intensity and maximal oxygen uptake. The investigators will evaluate different measures of vascular function (Pulse-wave velocity, Flow-mediated slowing, microvascular function) before and after each condition.

The study will involve two groups of participants: healthy individuals and prehypertensive individuals. The investigators aim to establish the reliability and validity of less-established methods of vascular function assessment (flow-mediated slowing and microvascular function) against established measures (pulse-wave velocity). The acute response of vascular function to different exercise intensities has not yet been thoroughly researched using the aforementioned measures in individuals with similar characteristics to the proposed study cohort.

详细描述

This study is a work package of the ACT-ON project, aimed at establishing the reliability and validity of flow-mediated slowing and microvascular function, as well as determine the acute response of different vascular function measures to different exercise conditions. The investigators aimed to include vascular function measures evaluating different parts of the vasculature (e.g. central, peripheral and microvasculature) to establish whether the specific response differs between healthy participants and participants at risk of developing cardiovascular diseases.

Data collection will be conducted using a range of instruments and tools in the following order.

To ensure compliance with the inclusion criteria, participants will undergo a screening visit prior to the enrollment in the study. The visit will take place in the morning including the following assessments: Standardized blood pressure (M6, Omron, Japan), height (GPM, Model 101, Switzerland) and weight (InBody 720, Biospace, South Korea) measurement, as well as the administration of the GPAQ questionnaire. Female participants will additionally complete a Reproductive status Questionnaire (RSQ) (Schmalenberger & Eisenlohr-Moul, 2019) to determine eligibility based on previously established inclusion and exclusion criteria. Participants will be advised to refrain from physical activity, alcohol and caffeine consumption in the days leading up to the visit, as well as to arrive well rested and in a fasted state.

Study protocol

After enrollment in the study, participants will complete three visits with 72h between each visit. The visits will be completed at the same hour of the day to ensure minimal circadian variability. Participants will be advised to refrain from physical exercise and consumption of alcohol and caffeine in the days leading up to the first visit, as well as during the study. Additionally, they will be advised to arrive well rested and to consume a standardized meal 2-3 hours before the visit. To enable physical activity monitoring during the study, participants will wear wrist monitors with 24-h measurement of heart rate on the wrist (Vantage V3, Polar, Finland). In the event that physical activity is detected during the course of the study, participants will be excluded from the study. Additionally, participants will be required to maintain a dietary intake log during the duration of the study.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Screening
盲法
Double (Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 50 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Normotensive participants inclusion criteria:
  • 18 - 50 years of age, BMI < 30, blood pressure (BP) within the optimal range according to the latest ESH guidelines (< 120 mmHg systolic and/or < 80 mmHg diastolic BP)
  • Sedentary or low active according to the Global Physical Activity Questionnaire (GPAQ) (Armstrong & Bull, 2006; Lim et al., 2012)
  • No prescribed medication and absence of chronic diseases
  • Inclusion criteria for prehypertensive individuals:
  • 18 - 50 years of age, BMI < 30
  • Diagnosed prehypertension by a clinican from the Hypertension clinic, University clinical centre of Ljubljana using established criteria
  • Sedentary or low or moderately active according to the Global Physical Activity Questionnaire (GPAQ)
  • No prescribed medication and absence of chronic diseases

排除标准

  • Blood pressure out of the optimal range (normotensives)
  • High level of phyisical activity (moderate or high active according to GPAQ)
  • Hypotension
  • Chronic diseases
  • Prescribed medication
  • Lower extremity injury in the last six months
  • Menopause
  • Absence of normal menstrual cycle
  • Pregnancy

结局指标

主要结局

Microvascular function

时间窗: At the beginning of each visit (T0) and immediately after each acute stimulus (T1)

Microvascular function will be mesured using near-infrared spectroscopy during and after a 5-minute occlusion of the brachial artery.

Arterial stiffness

时间窗: At the beginning of each visit (T0) and immediately after each acute stimulus (T1)

Arterial stiffness will be measured by pulse wave velocity

Flow-mediated slowing

时间窗: At the beginning of each visit (T0) and immediately after each acute stimulus (T1)

Flow-mediated slowing will be measured by pulse wave velocity deceleration after occlusion of the brachial artery.

次要结局

  • Blood pressure(Baseline)
  • Aerobic capacity(Baseline)
  • Blood markers(At the beginning of each visit (T0) and immediately after each acute stimulus (T1))

研究者

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

Simon Iskra

Principal Investigator

University of Ljubljana

研究点 (2)

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