Remote Monitoring of Home Exercise in Peripheral Arterial Disease
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
- 否
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
Subhash Banerjee
Principal Investigator
Dallas VA Medical Center
