跳至主要内容
临床试验/NCT04977258
NCT04977258Unknown不适用

Effect of Different Hydration Strategies on Autonomic Acceleration During Recovery in Individuals With Coronary Artery Disease Undergoing Aerobic Exercise

Universidade Estadual Paulista Júlio de Mesquita Filho2 个研究点 分布在 1 个国家目标入组 31 人开始时间: 2021年8月16日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
31
试验地点
2
主要终点
Heart rate variability

研究概览

简要总结

The need to restore water losses resulting from physical activity has become established and diffused into international consensus for healthy individuals or high-performance athletes. However, the influence of fluid replacement when administered during and after exercise on cardiac autonomic modulation with autonomic alterations known as the coronary arteries remain poorly understood. The aim of the study was to evaluate and compare whether different hydration strategies are able to promote acceleration of the recovery of autonomic modulation in individuals with coronary artery disease undergoing aerobic exercise. This study is a cross-over clinical trial, which will be developed based on an experimental procedure performed in four stages. A total of 31 individuals will be recruited in this study and will perform four standardized cardiovascular rehabilitation (CR) sessions. The participants will perform CR with mineral water intake in phase three and four. In phase three, the consumption will be done a quantity of water predetermined by the evaluator, based on the loss of body mass measured in the second session. In phase four, hydration will be carried out in an uncontrolled manner, according to the desire to drink water during the protocol.

研究设计

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

入排标准

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

入选标准

  • Men with coronary heart disease ischemia, over 45 years
  • At least three months of cardiovascular rehabilitation

排除标准

  • Smokers, alcoholics
  • Uncontrolled metabolic disease (eg, uncontrolled diabetes and thyroid diseases)
  • Abnormal hemodynamic responses during exercise such as disproportionate increase / fall of heart rate and / or blood pressure to low / high levels of load
  • Myocardial ischemia and / or severe ventricular arrhythmias during the exercise test

结局指标

主要结局

Heart rate variability

时间窗: up to six months

Linear indices of heart rate variability in the time domain (SDNN, rMSSD).

次要结局

未报告次要终点

研究者

发起方
Universidade Estadual Paulista Júlio de Mesquita Filho
申办方类型
Other
责任方
Principal Investigator
主要研究者

Luiz Carlos Marques Vanderlei

Principal Investigator

Universidade Estadual Paulista Júlio de Mesquita Filho

研究点 (2)

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