Clinical trial NCT01424020: Walking Estimated Limitation Calculated by History - Study 2
Official title: Estimation de la capacité Fonctionnelle à la Marche Par Questionnaire Clinique Chez Les Patients adressés Pour Bilan artériel Des Membres inférieurs
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Peripheral Artery Disease
Keywords: Questionnaire
peripheral artery disease
execise
Lead sponsor: University Hospital, Angers
Sponsor class: OTHER_GOV
First posted: 2011-08-26
Enrollment: 800
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: 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: 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)

Eligibility criteria: 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.

Primary outcomes:
measure: Proportion of questionnaires with errors after self completion
timeFrame: 1 day
Secondary outcomes:
measure: Correlation with ankle brachial index (ABI)
timeFrame: 1 day
measure: Correlation with treadmill result
timeFrame: 1 day
measure: Facility of the scoring of the questionnaires
timeFrame: 1 day
measure: Reliability of the questionnaire
timeFrame: 3 weeks
measure: sensitivity of the WELCH to changes
timeFrame: 1 year
Other outcomes:
Locations:
city: Angers
country: France
facility: Vascular investigation
city: Annecy
country: France
facility: Vascular Medicine
city: Aubenas
country: France
facility: Vascular Medicine
city: Ballan Mire
country: France
facility: Rehabilitation
city: Belfort
country: France
facility: Vascular Medicine
city: Caen
country: France
facility: Vascular Medicine
city: Castanet Tolosan
country: France
facility: Vascular Medicine
city: Champagnole
country: France
facility: Vascular Medicine
city: Chazelles Sur Lyon
country: France
facility: Vascular Medicine
city: Hauteville
country: France
facility: Rehabilitation
city: Paris
country: France
facility: Vascular Medicine
city: Perigueux
country: France
facility: Vascular Medicine
city: Perpignan
country: France
facility: Vascular Medicine
city: Reims
country: France
facility: Vascular Medicine
city: Sallanches
country: France
facility: Vascular Medicine
city: Tarbes
country: France
facility: Vascular Medicine
city: Villenave d'Ornon
country: France
facility: Vascular Medicine
city: Wattrelos
country: France
facility: Vascular Medicine
Study officials:
affiliation: University Hospital in Angers
name: Pierre ABRAHAM, MD; PhD
role: PRINCIPAL_INVESTIGATOR
References: