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Completed

NCT Number: NCT01654471

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

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

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Key information

Conditions

Peripheral Arterial Occlusive Disease Peripheral Arterial Occlusive Disease 1

Age range

19 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Seoul National University Hospital

Seoul, 110-744, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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)

Exclusion criteria

  • 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

Treatment and study plan

Primary outcomes

  1. Reproducibility of Korean version Walking Impairment Questionnaire

    Time frame: 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)

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

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Collaborators

  • Astellas Pharma Korea, Inc.

Registry information

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Jul 31, 2012
Registry last updated
Nov 21, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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