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

This study has been completed.
Sponsor:
Collaborator:
Astellas Pharma Korea, Inc.
Information provided by (Responsible Party):
Seung-Kee Min, Seoul National University Hospital
ClinicalTrials.gov Identifier:
NCT01654471
First received: July 27, 2012
Last updated: November 19, 2014
Last verified: November 2014

July 27, 2012
November 19, 2014
August 2012
September 2014   (final data collection date for primary outcome measure)
  • Reproducibility of Korean version Walking Impairment Questionnaire [ Time Frame: One month ] [ Designated as safety issue: No ]
    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 [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    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
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Complete list of historical versions of study NCT01654471 on ClinicalTrials.gov Archive Site
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Validation of the Korean Version of the Walking Impairment Questionnaire in Patients With Peripheral Arterial Disease
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.

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.

Observational
Observational Model: Case-Only
Time Perspective: Prospective
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Probability Sample

Patients with peripheral arterial disease

Peripheral Arterial Occlusive Disease
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  • Medical treatment
    only medical treatment (regardless of the kinds of medicine)
  • Surgical or endovascular treatemnt group
    patients underwent surgery or endovascular therapy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
47
September 2014
September 2014   (final data collection date for primary outcome measure)

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
Both
19 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
NCT01654471
WIQ-SNU
Yes
Seung-Kee Min, Seoul National University Hospital
Seoul National University Hospital
Astellas Pharma Korea, Inc.
Not Provided
Seoul National University Hospital
November 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP