跳至主要内容
临床试验/NCT02189018
NCT02189018已完成不适用

Activity To Improve Outcomes in Peripheral Arterial Disease

Baltimore VA Medical Center2 个研究点 分布在 1 个国家目标入组 208 人开始时间: 2014年8月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
208
试验地点
2
主要终点
Lower extremity perfusion

研究概览

简要总结

Peripheral artery disease (PAD) results in blockages of arteries (blood vessels) in the legs and decreased blood flow to the legs. This may cause difficulty or pain with walking or other activities that use leg muscles. Exercise may help improve blood flow in the legs and improve the ability to walk. This research project is being implemented in adults with PAD to examine the effects of exercise or weight loss programs on lower extremity blood flow, health, and physical function.

详细描述

This pilot study seeks to gather data on different exercise interventions in PAD. Collectively, the proposed studies will gather data on the role of novel exercise interventions in those with PAD who are receiving conservative treatment as well as those who have undergone an endovascular intervention for lower extremity arterial disease.

We hypothesize that patients who undergo an exercise intervention will: A) show improved lower extremity perfusion and B) improve their functional ability, compared to a standard care control group over 6 months of follow-up. We further hypothesize that these improvements are mediated through angiogenesis and increased perfusion of the lower limb, as well as improvements in muscle strength, mass, and function.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
21 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age 21-90 years
  • Ankle brachial index < 0.9

排除标准

  • Cancer under active treatment, except prostate, skin, and hematologic cancers
  • Planned for open lower extremity bypass surgery
  • Body mass index >45
  • Lower extremity gangrene

结局指标

主要结局

Lower extremity perfusion

时间窗: 6 months

Ankle brachial index and ultrasound quantification of muscle perfusion

次要结局

  • Functional capacity(6 months)

研究者

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

Brajesh K Lal

Professor

Baltimore VA Medical Center

研究点 (2)

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