NCT01654471

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
47

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Aug 2012

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 27, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 31, 2012

Completed
1 day until next milestone

Study Start

First participant enrolled

August 1, 2012

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2014

Completed
Last Updated

November 21, 2014

Status Verified

November 1, 2014

Enrollment Period

2.1 years

First QC Date

July 27, 2012

Last Update Submit

November 19, 2014

Conditions

Peripheral Arterial Occlusive Disease

Keywords

Walking Impairment QuestionnairePeripheral arterial occlusive diseaseKorean version

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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

Study Arms (2)

Medical treatment

only medical treatment (regardless of the kinds of medicine)

Surgical or endovascular treatemnt group

patients underwent surgery or endovascular therapy

Eligibility Criteria

Age19 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients with peripheral arterial disease

You may qualify if:

  • \~ 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Hospital

Seoul, 110-744, South Korea

Location

MeSH Terms

Conditions

Peripheral Arterial Occlusive Disease 1

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

July 27, 2012

First Posted

July 31, 2012

Study Start

August 1, 2012

Primary Completion

September 1, 2014

Study Completion

September 1, 2014

Last Updated

November 21, 2014

Record last verified: 2014-11

Locations

KR(1)