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临床试验/NCT01654471
NCT01654471已完成不适用

Validation of the Korean Version of the Walking Impairment Questionnaire in Patients With Peripheral Arterial Disease

Seoul National University Hospital1 个研究点 分布在 1 个国家目标入组 47 人开始时间: 2012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
47
试验地点
1
主要终点
Reproducibility of Korean version Walking Impairment Questionnaire

研究概览

简要总结

The aim of the study is to validate the Korean version of Walking Impairment Questionnaire in patients with peripheral arterial occlusive disease.

详细描述

First, the original version of WIQ will be translated into Korean, then it will be translated into English, again. The translated version will be sent to the original author to compare with the original version. After correcting, the Korean version will be completed.

The patients with peripheral arterial disease will fill in the Korean version of WIQ before starting treatments. Baseline results of arterial function test, toe-brachial index and treadmill test will be recorded. Three months later, the patients will complete the questionnaire again. Arterial function test, toe-brachial index and treadmill test also will be taken again after treatment and the correlation of WIQ and other exams will be evaluated.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

年龄范围
19 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 19~ 80 years
  • claudication
  • Ankle brachial index < 0.9 or TBI < 0.7 (in patients with DM and ABI higher than 1.3)
  • patients who can complete the treadmill test (slope 12%, 2.4km/hr)

排除标准

  • critical limb ischemia
  • Ankle pressure < 40mmHg
  • claudication due to other causes (i.e. spinal stenosis, arthritis, etc)
  • patients with high risk of coronary artery syndrome during treadmill test

结局指标

主要结局

Reproducibility of Korean version Walking Impairment Questionnaire

时间窗: One month

To test reliatbility of WIQ Korean ver., reproducibility of the test was assessed by test-retest procedure of the baseline and 1month afterwards (intraclass correlation coefficient)

Correlation of WIQ score improvement and change in ABI and treadmill test results

时间窗: 3 months

Correlation between changes in WIQ score and changes in ABI or treadmill test results (before and after surgical / radiological or pharmacological intervention) were assessed by Pearson's correlation test

次要结局

未报告次要终点

研究者

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

Seung-Kee Min

Professor

Seoul National University Hospital

研究点 (1)

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