Peripheral Artery DiseaseWELCHNCT01114178
Walking Impairment Questionnaire in PAD
An observational study of Peripheral Artery Disease, run by University Hospital, Angers at 1 site in France.
Trial summary
Purpose is to test and validate a new questionnaire (the WELCH questionnaire) to estimate walking capacity in patients with claudication Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Peripheral Artery Disease
- What is being tested?
- questionnaire
- How many people
- 340 participants
- Where
- 1 siteFrance
- Study dates
- Nov 2009to May 2012
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: patients referred for treadmill testing
Who may be able to join
- informed consent signed, french language fluent patients
Who cannot join
- rejection of the questionnaire
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Estimation de la capacité Fonctionnelle à la Marche Par Questionnaire Clinique Chez Des Patients adressés Pour un Test de Marche Sur Tapis Roulant
Purpose is to test and validate a new questionnaire (the WELCH questionnaire) to estimate walking capacity in patients with claudication
Read the detailed description
Questionnaires (WELCH and WIQ) submitted to patients referred for treadmill walking test Comparison of sore to MWD on treadmill. Comparison with WIQ will be performed
- Conditions
- Peripheral Artery Disease
- Being tested
- questionnaire
- Keywords
- questionnaire, peripheral artery disease, exercise
- Medical subject headings
- Peripheral Arterial Disease, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
questionnaireOther
self completed questionnaire supervised by a technician
| Study group | Role | What they receive |
|---|---|---|
| claudicants | patients referred for a treadmill test Receives: Other: questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
scoring of the WELCH questionnaire
predetermined score for the WELCH questionnaire answers (4 questions)
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2010 (estimated)
- Study startNov 2009
- Primary completionMay 2012
- Study completionMay 2012
Why it stopped: recruitment problem due to administrative process being too long
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Peripheral Artery DiseaseStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 340 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Angers
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- denise Jolivot, MD, Study chair, University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01114178
- Sponsor's protocol ID
- PL 2009/14
- Acronym
- WELCH
- Status last verified
- Dec 2016
- First submitted
- 28 Apr 2010
- Last updated
- 19 Dec 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Fouasson-Chailloux A, Abraham P, Vielle B, Laporte I, Omarjee L, Ouedraogo N. The correlation of the "Walking Estimated-Limitation Calculated by History" (WELCH) questionnaire with treadmill maximal walking time is not impaired by age, in patients with claudication. Qual Life Res. 2015 Aug;24(8):1857-64. doi: 10.1007/s11136-015-0915-9. Epub 2015 Jan 13.
PubMed 25578404Abraham P, Godet R, Harbonnier M, Laneelle D, Leftheriotis G, Ouedraogo N. External validation of the "walking estimated limitation calculated by history" (WELCH) questionnaire in patients with claudication. Eur J Vasc Endovasc Surg. 2014 Mar;47(3):319-25. doi: 10.1016/j.ejvs.2013.11.010. Epub 2013 Dec 3.
PubMed 24445082Mahe G, Ouedraogo N, Marchand J, Vielle B, Picquet J, Leftheriotis G, Abraham P. Self-reported estimation of usual walking speed improves the performance of questionnaires estimating walking capacity in patients with vascular-type claudication. J Vasc Surg. 2011 Nov;54(5):1360-5. doi: 10.1016/j.jvs.2011.05.048.
PubMed 22027439Mahe G, Ouedraogo N, Vasseur M, Faligant C, Saidi K, Leftheriotis G, Abraham P. Limitations of self-reported estimates of functional capacity using the Walking Impairment Questionnaire. Eur J Vasc Endovasc Surg. 2011 Jan;41(1):104-9. doi: 10.1016/j.ejvs.2010.10.002. Epub 2010 Nov 30.
PubMed 21123095
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Estimation de la capacité Fonctionnelle à la Marche Par Questionnaire Clinique Chez Des Patients adressés Pour un Test de Marche Sur Tapis Roulant
- ClinicalTrials.gov ID
- NCT01114178
- Acronym / sponsor ID
- WELCH / PL 2009/14
- Conditions
- Peripheral Artery Disease
- Keywords
- questionnaire, peripheral artery disease, exercise
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: recruitment problem due to administrative process being too long
- Enrolment
- 340 participants (actual)
- Lead sponsor
- University Hospital, AngersOther government
- Study start
- Nov 2009
- Primary completion
- May 2012 (actual)
- Study completion
- May 2012 (actual)
- First posted
- 3 May 2010 (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.
Purpose is to test and validate a new questionnaire (the WELCH questionnaire) to estimate walking capacity in patients with claudication
Detailed description
Questionnaires (WELCH and WIQ) submitted to patients referred for treadmill walking test Comparison of sore to MWD on treadmill. Comparison with WIQ will be performed
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| claudicants | – | Other: questionnairepatients referred for a treadmill test |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- patients referred for treadmill testing
Key inclusion criteria (1 listed)
- informed consent signed, french language fluent patients
Key exclusion criteria (1 listed)
- rejection of the questionnaire
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| questionnaireself completed questionnaire supervised by a technician | Other | claudicants |
Primary outcome
scoring of the WELCH questionnaire
Time frame: 1 day
predetermined score for the WELCH questionnaire answers (4 questions)
Results and safety
The study was stopped early (reason given: recruitment problem due to administrative process being too long). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2016.
- Derived from this study: PubMed 25578404Fouasson-Chailloux A, Abraham P, Vielle B, Laporte I, Omarjee L, Ouedraogo N. The correlation of the "Walking Estimated-Limitation Calculated by History" (WELCH) questionnaire with treadmill maximal walking time is not impaired by age, in patients with claudication. Qual Life Res. 2015 Aug;24(8):1857-64. doi: 10.1007/s11136-015-0915-9. Epub 2015 Jan 13.
- Derived from this study: PubMed 24445082Abraham P, Godet R, Harbonnier M, Laneelle D, Leftheriotis G, Ouedraogo N. External validation of the "walking estimated limitation calculated by history" (WELCH) questionnaire in patients with claudication. Eur J Vasc Endovasc Surg. 2014 Mar;47(3):319-25. doi: 10.1016/j.ejvs.2013.11.010. Epub 2013 Dec 3.
- Derived from this study: PubMed 22027439Mahe G, Ouedraogo N, Marchand J, Vielle B, Picquet J, Leftheriotis G, Abraham P. Self-reported estimation of usual walking speed improves the performance of questionnaires estimating walking capacity in patients with vascular-type claudication. J Vasc Surg. 2011 Nov;54(5):1360-5. doi: 10.1016/j.jvs.2011.05.048.
- Derived from this study: PubMed 21123095Mahe G, Ouedraogo N, Vasseur M, Faligant C, Saidi K, Leftheriotis G, Abraham P. Limitations of self-reported estimates of functional capacity using the Walking Impairment Questionnaire. Eur J Vasc Endovasc Surg. 2011 Jan;41(1):104-9. doi: 10.1016/j.ejvs.2010.10.002. Epub 2010 Nov 30.
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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.
denise Jolivot, MD study chair
University Hospital
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 Artery Disease, run by University Hospital, Angers at 1 site in France.
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 1 inclusion and 1 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: stopped early, as of the sponsor's last update on 19 Dec 2016. 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 France. 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 was stopped early (reason given: recruitment problem due to administrative process being too long). Results are not available in the source record.
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?
scoring of the WELCH questionnaire (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01114178, which also lists 4 linked publications.
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 19 Dec 2016.