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临床试验/NCT02510807
NCT02510807
Unknown
不适用

The PaWS (Pedometer and Walking Study): Comparing Education Alone and Education With Pedometer/Exercise Log Use in Self-monitored Walking in Peripheral Arterial Disease (PAD)

University Health Network, Toronto1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2015年7月最近更新:

概览

阶段
不适用
入组人数
200
试验地点
1
主要终点
Increased walking distance

概览

简要总结

The literature has shown that supervised exercise programs for patients with PAD and who report intermittent claudication (IC) have improved health outcomes, but this is not locally available. Introducing the use of a pedometer may act as a method to encourage patients to continue on their independent exercise regimen. There is very little literature which has examined the effectiveness using pedometers as a measure of compliance within this population.

详细描述

It has been established that exercise therapy has a central role in the management of peripheral arterial disease. Such treatment should be comprised of intermittent walking of sufficient distance to induce significant discomfort, and be carried out over a period of at least several months. Supervised exercise training utilizing intermittent treadmill walking is a well-validated treatment for claudication. Most prospective randomized single site studies have reported significant improvement in walking distance following supervised exercise training but not with non-supervised regimens.

Furthermore, this has been acknowledged in both the current AHA/ACC 'Guidelines for the management of patients with peripheral arterial disease', which recommends supervised exercise training as an initial treatment modality with a Class 1A level of evidence (highest), as well as in the TransAtlantic Intersocietal Consensus, which provides an 'A' categorical recommendation. In spite of these peer-reviewed, published recommendations, supervised exercise training remains little used, expensive, not reimbursed by Ontario Health Insurance Plan, and therefore is rarely available to patients with claudication in Ontario.

The purpose of this multicentre study is to examine whether the use of a pedometer enhances patient compliance with walking as compared to usual care.

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 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Males or females with a diagnosis of PAD (ABI \< 0.9) who report symptoms of IC,
  • Independent with ambulation (assistive device is permitted) and living independently,
  • No previous vascular surgical interventions,
  • Fluency in English is preferable but not required,
  • Patients need to be willing to return for monthly assessment.

排除标准

  • Previous vascular surgical intervention,
  • Non-ambulatory,
  • Unstable cardiac status (cardiac event \< 6 months),
  • Cognitive difficulties,
  • Unwilling to engage in regular exercise

结局指标

主要结局

Increased walking distance

时间窗: 6 months

Six Minute Walk Test

Time to claudication

时间窗: 6 Months

Six Minute Walk Test

次要结局

  • Quality of Life(6 months)
  • Blood Pressure(6 months)
  • Ankle Brachial Index(6 months)

研究者

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

Graham Roche-Nagle

Vascular Surgeon

University Health Network, Toronto

研究点 (1)

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