Peripheral Arterial Occlusive DiseaseNCT01654471
Validation of the Korean Version of the Walking Impairment Questionnaire in Patients With Peripheral Arterial Disease
An observational study of Peripheral Arterial Occlusive Disease, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
The aim of the study is to validate the Korean version of Walking Impairment Questionnaire in patients with peripheral arterial occlusive disease. Read more about this study
- Who is it for?
- Ages 19 to 80 years
- Conditions the study is for
- Peripheral Arterial Occlusive Disease
- How many people
- 47 participants
- Where
- 1 siteSouth Korea
- Study dates
- Aug 2012to Sep 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with peripheral arterial disease
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
The aim of the study is to validate the Korean version of Walking Impairment Questionnaire in patients with peripheral arterial occlusive disease.
Read the 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.
- Conditions
- Peripheral Arterial Occlusive Disease
- Keywords
- Walking Impairment Questionnaire, Peripheral arterial occlusive disease, Korean version
- Medical subject headings
- Peripheral Arterial Occlusive Disease 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Medical treatment | only medical treatment (regardless of the kinds of medicine) | |
| Surgical or endovascular treatemnt group | patients underwent surgery or endovascular therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2012 (estimated)
- Study startAug 2012
- Primary completionSep 2014
- Study completionSep 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral Arterial Occlusive DiseaseStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Astellas Pharma Korea, Inc.
- Responsible party
- Principal investigator, Seung-Kee Min, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01654471
- Sponsor's protocol ID
- WIQ-SNU
- Status last verified
- Nov 2014
- First submitted
- 27 Jul 2012
- Last updated
- 21 Nov 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of the Korean Version of the Walking Impairment Questionnaire in Patients With Peripheral Arterial Disease
- ClinicalTrials.gov ID
- NCT01654471
- Acronym / sponsor ID
- WIQ-SNU
- Conditions
- Peripheral Arterial Occlusive Disease
- Keywords
- Walking Impairment Questionnaire, Peripheral arterial occlusive disease, Korean version
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Collaborators
- Astellas Pharma Korea, Inc.
- Study start
- Aug 2012
- Primary completion
- Sep 2014 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 31 Jul 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of the study is to validate the Korean version of Walking Impairment Questionnaire in patients with 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
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Medical treatment | – | –only medical treatment (regardless of the kinds of medicine) |
| Surgical or endovascular treatemnt group | – | –patients underwent surgery or endovascular therapy |
Who may qualify
- Ages
- 19 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with peripheral arterial disease
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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)
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Peripheral Arterial Occlusive Disease, run by Seoul National University Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Nov 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reproducibility of Korean version Walking Impairment Questionnaire (time frame: One month). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Nov 2014.