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

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ClinicalTrials.gov Identifier: NCT01654471
Recruitment Status : Completed
First Posted : July 31, 2012
Last Update Posted : November 21, 2014
Information provided by (Responsible Party):

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

Condition or disease
Peripheral Arterial Occlusive Disease

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.

Study Design

Study Type : Observational
Actual Enrollment : 47 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Validation of the Korean Version of the Walking Impairment Questionnaire in Patients With Peripheral Arterial Disease
Study Start Date : August 2012
Primary Completion Date : September 2014
Study Completion Date : September 2014

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U.S. FDA Resources

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

Outcome Measures

Primary Outcome Measures :
  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

Eligibility Criteria

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Ages Eligible for Study:   19 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   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:

  • 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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01654471

Korea, Republic of
Seoul National University Hospital
Seoul, Korea, Republic of, 110-744
Sponsors and Collaborators
Seoul National University Hospital
Astellas Pharma Korea, Inc.
More Information

Responsible Party: Seung-Kee Min, Professor, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT01654471     History of Changes
Other Study ID Numbers: WIQ-SNU
First Posted: July 31, 2012    Key Record Dates
Last Update Posted: November 21, 2014
Last Verified: November 2014

Keywords provided by Seung-Kee Min, Seoul National University Hospital:
Walking Impairment Questionnaire
Peripheral arterial occlusive disease
Korean version

Additional relevant MeSH terms:
Peripheral Arterial Disease
Peripheral Vascular Diseases
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases