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临床试验/NCT05209724
NCT05209724Unknown不适用

Remote Monitoring of Home Exercise in Peripheral Arterial Disease

Dallas VA Medical Center2 个研究点 分布在 1 个国家目标入组 56 人开始时间: 2021年11月21日最近更新:
适应症

试验速览

阶段
不适用
入组人数
56
试验地点
2
主要终点
Change in 6 minute walk test distance between groups

研究概览

简要总结

Many patients with blockages in the arteries in their legs (peripheral arterial disease, "PAD") suffer from pain in their legs when walking. Exercise therapy is known to decrease pain levels as well as increase the distance that patients with PAD can walk. The purpose of this study is to understand whether home exercise using a digital exercise monitoring system (LIVMOR) with provider supervision/ feedback will improve walking distance compared to those undergoing home exercise using the same monitoring system but without provider supervision/ feedback.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
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

  • Diagnosis of PAD (based on ABI <0.9 in either leg or prior intervention) with mild/moderate claudication

排除标准

  • Prior above ankle amputation
  • Wheelchair bound
  • Inability to walk >200m during 6 min walk test
  • Use of walking aid other than cane
  • Walking impairment for reason other than PAD
  • Critical limb ischemia
  • Planned vascular surgery within next 3 months, recent surgery within past 3 months

结局指标

主要结局

Change in 6 minute walk test distance between groups

时间窗: 12 weeks

Change in 6 minute walk test distance between groups

次要结局

  • Change in VascuQOL-6 (VQ6) quality of life survey(12 weeks)
  • Change in Walking Impairment Questionnaire score(12 weeks)

研究者

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

Subhash Banerjee

Principal Investigator

Dallas VA Medical Center

研究点 (2)

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