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临床试验/NCT05611021
NCT05611021已完成不适用

Acute Responses to Arm-Crank Exercise on Cardiovascular Function of Patients With Peripheral Artery Disease: Randomized Crossover Study

University of Nove de Julho1 个研究点 分布在 1 个国家目标入组 17 人开始时间: 2022年6月8日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
17
试验地点
1
主要终点
Change from baseline in vascular function post-exercise in the brachial and femoral arteries.

研究概览

简要总结

The aim of this study is to analyze acute responses of arm-cranking exercise on cardiovascular function of peripheral arterial disease patients and compare it to the main exercise recommendation, walking exercise.

详细描述

Twenty patients with peripheral arterial disease and claudication symptoms will be recruited. The patients will perform three experimental conditions, in randomized order (walking, arm-cranking and control). The exercise conditions will be composed of 15 bouts of 2 minutes exercise with an intensity equivalent to 13-15 on Borg's Subjective Perceived Exertion Scale. During the experimental conditions (walking, arm-cranking and control) blood pressure, heart rate and cerebral blood velocity will be evaluated, along with perceived exertion and affective responses. Before and after experimental conditions, vascular function, blood pressure, heart rate variability, cerebral blood velocity, subjective perceived exertion and affective responses will be evaluated.

研究设计

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

盲法说明

The outcomes assessor is blind for the condition performed by the patients.

入排标准

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

入选标准

  • •Peripheral arterial disease diagnosis;
  • •Age ≥ 40 years old;
  • •If a woman, be in menopause without the use of hormone replacement therapy;
  • •Do not be an active smoker;
  • •Be apt to perform exercise.

排除标准

  • •Any change in medication;
  • •Any health impairment that contraindicates the practice of physical exercise.

研究组 & 干预措施

Walking Condition

Experimental

In the walking condition, the patients will perform fifteen bouts of two minutes of treadmill walking with an interval of two minutes between bouts, at an intensity equivalent to 13-15 on Borg's subjective perceived exertion scale. The condition will have a total of sixty minutes of duration.

干预措施: Exercise (Behavioral)

Arm-Cranking Condition

Active Comparator

In the arm-cranking condition, the patients will perform fifteen bouts of two minutes of arm-cranking with an interval of two minutes between bouts, at an intensity equivalent to 13-15 on Borg's subjective perceived exertion scale. The condition will have a total of sixty minutes of duration.

干预措施: Exercise (Behavioral)

Control Condition

Sham Comparator

The control condition will consist of resting in the standing position for thirty minutes. The patients will be instructed to rest in the sitting position for two minutes at periods equivalent to the intervals from the exercise conditions, totalling sixty minutes of duration.

干预措施: Exercise (Behavioral)

结局指标

主要结局

Change from baseline in vascular function post-exercise in the brachial and femoral arteries.

时间窗: Change from baseline at post-intervention, after 20 minutes.

Vascular function will be measured in the supine position by the flow-mediated dilation (FMD) technique, through Doppler ultrasonography.

次要结局

  • Change from baseline in cerebral blood velocity post-exercise.(Change from baseline at 35 minutes after the beginning of the exercise.)
  • Change from baseline in blood pressure post-exercise.(Change from baseline at post-intervention, after 10 minutes.)
  • Change from baseline in heart rate variability post-exercise.(Change from baseline at post-intervention, after 30 minutes.)

研究者

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

Marilia de Almeida Correia

PhD

University of Nove de Julho

研究点 (1)

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