Walking Estimated Limitation Calculated by History - Study 2

Study Overview
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Brief Summary
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The purpose of this study is to test and validate a new questionnaire in order to get a walking estimated limitation calculated by history (WELCH) in patients referred for vascular investigations.

Detailed Description
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Two questionnaires the WELCH and the walking impairment questionnaire (WIQ) are submitted to patients referred for vascular investigations for suspêcted peripheral arterial disease (PAD). Comparison of score to hemodynamic parameters (first goal) or maximal walking distance (MWD) on treadmill (secondary goal). Scoring of the WIQ is performed according to references. Scoring of the WELCH has been submitted for copyright protection (involves a series of 4 additions a subtraction and a single multiplication)

Official Title
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Estimation de la capacité Fonctionnelle à la Marche Par Questionnaire Clinique Chez Les Patients adressés Pour Bilan artériel Des Membres inférieurs

Conditions
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Peripheral Artery Disease

Intervention / Treatment
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* Other: Questionnaire


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: French Native language 18 years old or older Signed consent Covered by the French social care system Exclusion Criteria: Unable to participate for administrative reasons Psychiatric troubles Pain at rest or critical limb ischemia Unable to walk (ex: wheelchair subjects) Note: previous inclusion in the protocole is note an exclusion criterion for a new participation.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: questionnaire<br>Patients suspected of peripheral artery disease and, as such, referred for a vascular investigations and submitted the WELCH questionnaire | Other: Questionnaire<br>* Self completed questionnaire, Supervised by the physician Ankle brachial index (ABI) calculation Maximal walking distance (MWD) on treadmill or over the 6 minutes walking test (when available)<br>* Other names: Walking estimated limitation calculated by history (WELCH);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of questionnaires with errors after self completion | Analysis of first inclusion only in patients that are included multiple times over the study period. Predetermined score for the WELCH questionnaire answers [(4 items); (4 additions & 1 multiplication)] and WIQ... estimation of the percentage of errors with 95% confidence interval. Comparison of the two percentages | 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlation with ankle brachial index (ABI) | Analysis of first inclusion only in patients that are included multiple times over the study period. Calculation of questionnaire scores from predetermined methods and analysis of the coefficient of determination and coefficient of correlation to minimal ABI | 1 day | 
| Correlation with treadmill result | Analysis of first inclusion only in patients that are included multiple times over the study period.Calculation of questionnaires score from predetermined methods and analysis of the coefficient of determination and coefficient of correlation to maximal walking distance on treadmill, in the subgroup of patients that have a routine treadmill scheduled during the visit. | 1 day | 
| Facility of the scoring of the questionnaires | Proportion of WELCH scores calculated by physician and comparison to the proportion of WIQ score calculated by physicians as a estimation of the facility to calculate the score by mental calculation in routine | 1 day | 
| Reliability of the questionnaire | Comparison of the scores of the WELCH in the patients that may be seens within 3 weeks of their first inclusion, for any reasons, (e.i. seen first for a doppler and two weeks later for a treadmill test)over the study period. Analysis of the reliability through the coefficient of variation of the score. | 3 weeks | 
| sensitivity of the WELCH to changes | Comparison of the scores of the WELCH in the patients that may be seens within 1 year from their first inclusion, for any reasons, (e.i. seen follow up of their disease)over the study period. Analysis of the changes of the score to changes of the ABI. Analysis of the changes of the score to changes in maximal walking distance if available. | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Questionnaire, peripheral artery disease, execise