跳至主要内容
临床试验/NCT06068504
NCT06068504已完成不适用

Shear Stress in the Arteries of the Lower Limbs During Arm Cranking Exercise in Patients With Peripheral Arterial Disease

University of Nove de Julho1 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2023年11月1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
15
试验地点
1
主要终点
Femoral artery diameter [mm]

研究概览

简要总结

The aim of the study will be to evaluate shear stress and blood flow parameters in lower limb arteries during arm cycle ergometer exercise in participants with peripheral artery disease. Twenty patients participants with peripheral artery disease and claudication symptoms will be recruited. Participants will perform 3 experimental sessions in random order. Iarm-cranking (15 sets of two minutes exercise), warm water foot immersion, and control. During the interventions, blood pressure and heart rate will be assessed every 6 minutes. Measurements of arterial diameter, blood flow, anterograde and retrograde shear stress of the femoral artery will be evaluated using a two-dimensional ultrasound device with spectral Doppler.

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
None

入排标准

年龄范围
50 Years 至 100 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •clinical diagnosis of peripheral artery disease or ankle-brachial index less than 0.90 in one or both limbs
  • •do not present peripheral neuropathy;
  • •be able to exercise after medical approval
  • •aged 50 or over.

排除标准

  • •Medication change during the study
  • •Health problems that contraindicates the practice of physical exercise.

研究组 & 干预措施

Arm-cranking exercise

Experimental

Patients will be perform arm-cranking exercise. The exercise will be performed in 15 sets of 2 min of exercise at a moderate intensity (13-15 in Borg scale)

干预措施: Arm-cranking exercise (Other)

Heating

Active Comparator

Patients will perform 15 sets of 2 min of immersion of their foot in a warm water (42 degrees)

干预措施: Heating (Other)

Control

No Intervention

Patients will remain seated for 60 min

结局指标

主要结局

Femoral artery diameter [mm]

时间窗: Before the intervention and at 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, and 30 minutes into the intervention

Measurements will be obtained through duplex ultrasound in accordance with global recommendations.

Femoral artery Blood flow [mL/min]

时间窗: Before the intervention and at 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, and 30 minutes into the intervention

Measurements will be obtained through duplex ultrasound in accordance with global recommendations.

Femoral artery shear rate [sec.-1]

时间窗: Before the intervention and at 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, and 30 minutes into the intervention

Measurements will be obtained through duplex ultrasound in accordance with global recommendations.

次要结局

  • Brachial systolic and diastolic blood pressure [mmHg](Before the intervention and at 1, 3, 5, 7, 9, 11, 13, 15, 17, 19, 21, 23, 25, 27, and 29 minutes into the intervention)
  • Heart rate [bpm](Before and up to 30 minutes into the intervention)

研究者

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

Raphael Mendes Ritti Dias

Principal Investigator

University of Nove de Julho

研究点 (1)

Loading locations...

相似试验