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

Peripheral Arterial Occlusive Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01654471
• Other study ID #: WIQ-SNU
• Status: Completed
• Phase: N/A
• First received: July 27, 2012
• Last updated: November 19, 2014
• Start date: August 2012
• Est. completion date: September 2014

Study information

• Verified date: November 2014
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 47
• Est. completion date: September 2014
• Est. primary completion date: September 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 19 Years to 80 Years

Eligibility

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

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Arterial Occlusive Diseases
• Peripheral Arterial Disease
• Peripheral Arterial Occlusive Disease
• Peripheral Vascular Diseases

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (2)

Lead Sponsor	Collaborator
Seoul National University Hospital	Astellas Pharma Korea, Inc.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	One month	No
Primary	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	3 months	No