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临床试验/NCT01866891
NCT01866891已完成不适用

Effects of Regular Perdialytic Physical Activity on the Peripheral Microcirculation in Chronic Hemodialysis Patients

Hospices Civils de Lyon2 个研究点 分布在 1 个国家目标入组 27 人开始时间: 2012年4月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
27
试验地点
2
主要终点
Increase of cutaneous lower extremity perfusion.

研究概览

简要总结

Chronic kidney disease (CKD) is associated with high level of peripheral arterial disease (PAD). This could lead wounds, infections then amputations or deaths by impairment of the peripheral cutaneous perfusion. Medical therapies are presently unable to cure, but only slow down these disorders. Impact of exercise and lower extremity PAD rehabilitation is decreased by the significant inactivity of the chronic hemodialysis patients. Recently, many studies have shown several various favorable effects of the perdialytic physical activity. There is currently no data about effects of the perdialytic activity on the lower extremity perfusion. The aim of this clinical study is to show the impact of three months perdialytic cycling on the microcirculation, in chronic hemodialysis patients. Primary outcome will be the increase of cutaneous perfusion, assessed by measuring transcutaneous oxygen pressure (tcPO2) on about twenty patients.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

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

入选标准

  • Patients performing chronic hemodialysis for more than 3 months
  • Adult aged > or = 18 years old
  • Information letter delivered to subjects
  • Written free informed consent
  • Clinically stable patients
  • Voluntary patients to perform 30 minutes cycling per dialysis session
  • Social French Security Affiliated subjects

排除标准

  • Subjects without inclusion criteria
  • Pregnant women
  • Subjects protected by the law
  • Physical impossibility to achieve exercise
  • Medical contraindication to perform physical exercise

结局指标

主要结局

Increase of cutaneous lower extremity perfusion.

时间窗: TcPO2 will be performed at the inclusion and just after the end of the three month study period

次要结局

  • Vascular assessment : Doppler and Index of systolic blood pressure(At the inclusion and after the end of the three month study period)
  • Related quality of life(at the inclusion and after the end of the three month study period)
  • Appetite (score)(at the inclusion and after the end of the three month study period)
  • Daily activity (Seven days pedometers)(at the inclusion and after the end of the three month study period)
  • Protein intake (n-PCR)(at the inclusion and after the end of the three month study period)
  • nutritional biological status (creatinin, albumin and transthyretin protein level)(at the inclusion and after the end of the three month study period)
  • strength (handgrip test)(at the inclusion and after the end of the three month study period)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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