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临床试验/NCT04200716
NCT04200716进行中(未招募)不适用

Evaluation of Vascular Responses to Moderate-intensity Continuous and High-intensity Interval Physical Exercise in Individuals With Prehypertension: a Randomized Trial

University of Sao Paulo General Hospital1 个研究点 分布在 1 个国家目标入组 22 人开始时间: 2018年7月3日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
22
试验地点
1
主要终点
Changes in arterial stiffness by piezoelectric method (Complior)

研究概览

简要总结

Individuals with prehypertension, diagnosed according to the 7th Brazilian Guidelines on Hypertension with the presence of systolic blood pressure (SBP) between 121 and 139 and / or diastolic (DBP) between 81 and 89 mmHg, are more likely to become hypertensive and to develop cardiovascular complications. Moreover, they already have alterations in the function of large arteries that may play a role in the development of the disease in the future. An option in the prevention / treatment of hypertension is the moderate intensity physical training, but high intensity interval training offers the possibility of greater exercise adherence, since it can be performed with less volume and less time spent, with the same benefits than moderate exercise, or even higher, being preferred by the population. Among these benefits, the investigators can mention the post-exercise hypotension (PEH) which occurs in normotensive, prehypertensive, and hypertensive individuals, due the decreased in sympathetic nerve activity and improved in vascular function. Also, selected participants with prehypertension can present a profile of masked hypertension, identified only by 24 hours ambulatory BP monitoring (ABPM). Given the possible differences between vascular responses to exercise intensities, the investigators intend to compare, in prehypertensive patients, the vascular responses of large arteries by noninvasive methods and PEH to a session of high intensity exercise and a session of moderate intensity continuous exercise. In addition, to study some of the possible physiological variables involved in this response by measuring heart rate variability. It is expected to find differences in vascular responses according to the presence of masked hypertension. Twenty two prehypertensive individuals aged between 30 and 60 years of both sexes will be studied. Subjects will perform cardiopulmonary testing and baseline vascular measurements (central pressure and pulse wave velocity measurements by three different methods), as well as 24 -hour ABPM. The vascular measurements will be repeated immediately after, and 24 hours after each session. Each participant will perform the session of one type of exercise in one day, and after three days will perform the other, with random distribution to the sequence of exercise type. Participants will perform 24-hour ABPM prior to exercise and for 24 hours after each exercise session. Data will be compared by appropriate statistical analysis.

详细描述

The measurement of central pressure and pulse wave velocity are achieved by three follow devices: Complior® , Sphygmocor® and Arteriograph®. The heart rate variability is achieved by Polar® device.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Prevention
盲法
None

入排标准

年龄范围
30 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Age ≥30 and ≤60 years old
  • Prehypertension, according to the 7 th Brazilian Arterial Hypertension Guideline values
  • Both sexes
  • Those who agree to sign the free and informed consent form

排除标准

  • Engaged in other studies or programs of physical activity or training
  • In drug treatment (for hypertension or other metabolic disease)
  • Unable to perform exercise on exercise bike
  • Presence of cardiovascular or metabolic disease (eg diabetes, hypercholesterolemia)

结局指标

主要结局

Changes in arterial stiffness by piezoelectric method (Complior)

时间窗: Baseline, immediately after exercise and 24 hours after exercise

Changes in arterial function behavior in response to two different physical exercise intensities.

Methods of measuring arterial stiffness: piezoelectric, tonometric and oscillometric

时间窗: Baseline.

Comparison of methods of evaluation of early markers of cardiovascular disease.

次要结局

  • Changes in arterial stiffness by three methods: piezoelectric, tonometric and oscillometric(Baseline, immediately after exercise and 24 hours after exercise.)
  • Changes in heart rate variability(Baseline, immediately after exercise and 24 hours after exercise)
  • Ambulatory systolic blood pressure measurement(During 24 hours after each exercise session)
  • Ambulatory diastolic blood pressure measurement(During 24 hours after each exercise session)

研究者

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

Luiz Aparecido Bortolotto

Director of Hypertension Unity Professor of Cardiology Department of Medical School São Paulo University

University of Sao Paulo General Hospital

研究点 (1)

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