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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
  Purpose

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


Condition
Peripheral Arterial Occlusive Disease

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Seoul National University Hospital:

Primary Outcome Measures:
  • 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


Enrollment: 47
Study Start Date: August 2012
Study Completion Date: September 2014
Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
Medical treatment
only medical treatment (regardless of the kinds of medicine)
Surgical or endovascular treatemnt group
patients underwent surgery or endovascular therapy

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.

  Eligibility

Ages Eligible for Study:   19 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Patients with peripheral arterial disease

Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01654471

Locations
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

No publications provided

Responsible Party: Seung-Kee Min, Professor, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT01654471     History of Changes
Other Study ID Numbers: WIQ-SNU
Study First Received: July 27, 2012
Last Updated: November 19, 2014
Health Authority: Korea: Institutional Review Board

Keywords provided by Seoul National University Hospital:
Walking Impairment Questionnaire
Peripheral arterial occlusive disease
Korean version

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

ClinicalTrials.gov processed this record on November 27, 2014