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CompletedNCT01654471Updated Nov 21, 2014

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

An observational study in Peripheral Arterial Occlusive Disease, sponsored by Seoul National University Hospital. Completed at 1 site in Korea, Republic of. Open to participants aged 19 Years to 80 Years. Per ClinicalTrials.gov, last updated 2014-11-21.

Sponsored by Seoul National University Hospital · Observational

Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
47
Ages
19 Years to 80 Years
Sex
All
01

Study summary

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

Read the detailed description

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.

02

Conditions studied

  • Peripheral Arterial Occlusive Disease

Keywords

  • Walking Impairment Questionnaire
  • Peripheral arterial occlusive disease
  • Korean version
03

In context

Peripheral Arterial Disease

1,542 studies on the registry are indexed under Peripheral Arterial Disease; 282 are open to participants now.

This study's enrollment of 47 is below the median of 190 across 410 observational studies indexed under Peripheral Arterial Disease.

Browse Peripheral Arterial Disease studies →

Lead sponsor

Seoul National University Hospital is the lead sponsor of 1,860 studies on the registry; 275 are open to participants now.

Of its 12 completed or terminated interventional studies of FDA-regulated products, 2 (17%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
19 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Patients with peripheral arterial disease

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

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
05

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
47 participants (actual)

Groups and cohorts

  • Medical treatment

    only medical treatment (regardless of the kinds of medicine)

  • Surgical or endovascular treatemnt group

    patients underwent surgery or endovascular therapy

06

What researchers measure

Primary outcomes

  1. Reproducibility of Korean version Walking Impairment Questionnaire

    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)

    Time frame: One month

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

    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

    Time frame: 3 months

07

Study locations

1 site
  • Seoul National University Hospital
    Seoul, 110-744, Korea, Republic of
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 21, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01654471
Lead sponsor
Seoul National University Hospital
Collaborators
Astellas Pharma Korea, Inc.
Responsible party
Seung-Kee Min (Professor, Seoul National University Hospital) — Principal investigator
First posted
Jul 31, 2012
Start date
Aug 2012
Primary completion
Sep 2014
Completion
Sep 2014
Last update
Nov 21, 2014

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2014. You cannot join it, but the record below documents what was studied.

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