- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01484509
Subjective and Objective Methods of Assessing Walking Limitation Due to Claudication
The Estimation of Ambulation Capacity by History Questionnaire (EACH-Q): An Assessment of Its Validity and Inter-day Reproducibility in Patients With Vascular-type Claudication
Leg artery disease is a common condition in which fatty deposits develop in the blood vessels that supply the legs. Many patients with leg artery disease experience a cramp-like leg pain during walking that is relieved by rest; this is called intermittent claudication. To help determine the severity of leg artery disease, patients may be questioned about how far they can walk before claudication pain forces them to stop. However, this information is usually of limited use because most patients poorly estimate their walking capacity. The investigators have developed a simple questionnaire to help estimate walking capacity in patients with leg artery disease. The purpose of this study is to test the validity and reliability of this questionnaire. By validity, the investigators mean the extent to which the questionnaire measures what it is supposed to measure (walking capacity). By reliability, the investigators mean the extent to which the questionnaire produces the same results over time when completed on two different days.
The investigators hypothesise that the investigators simple questionnaire will be valid and reliable.
Study Overview
Status
Conditions
Detailed Description
Claudication is a chronic condition that impairs walking capacity. Lower-extremity peripheral arterial disease (PAD) is a frequent cause of claudication. Claudication is suspected to be vascular-type (i.e. of arterial origin) when pain or discomfort occurs in the leg muscles during exercise and is relieved within 10 min of rest. The "maximal walking distance" (MWD; the distance at which pain forces the patient to stop walking) is of great importance for assessing the severity of claudication. Patient interview is the most readily accessible way of estimating walking capacity in routine clinical practice; however, patients with PAD typically poorly estimate their walking capacity. Open questions about the distance a patient can walk before limb pain or discomfort forces them to stop lack standardisation. Questions such as "Because of a health or physical problem, do you have any difficulty walking for one mile?" only allow for a yes/no response. The functional status component of the 86-item PAVK-86 questionnaire appears useful for estimating MWD, but this is a time-consuming tool. The Walking Impairment Questionnaire (WIQ), which was proposed over a decade ago to standardise the estimation of walking capacity by patient interview, is widely used. However, the WIQ is also relatively complex (14 items with 5 possible answers for each item: 70 boxes), which often results in a large number of errors when self-completed by the patient. Furthermore, the WIQ score is difficult to obtain by mental calculation.
The investigators have developed a simple, 4-item questionnaire, called the Estimation of Ambulation Capacity by History Questionnaire (EACH-Q), for estimating walking capacity in patients with symptomatic PAD (vascular-type claudication). The EACH-Q estimates the maximal duration that can be achieved (8 possibilities ranging impossible to 3 hours or more) at 4 different displacement speeds (from slow walking to running). Scores can be obtained easily by multiplying the rank of each possible answer (impossible being zero) by a speed factor. We recently validated the EACH-Q against constant-load treadmill-walking-test performance in patients suffering from vascular-type claudication. However, further research is needed to assess the validity of the EACH-Q against other objective tests of walking capacity (e.g. incremental treadmill-walking test, 6-min walk test), and to assess its reproducibility.
Hence, the aims of this study are: (i) to assess the validity of the EACH-Q against objective measures of walking capacity obtained from the Gardner-Skinner incremental treadmill-walking test and the 6-min walk test, and; (ii) to assess the inter-day reproducibility of the EACH-Q. The results will be compared against those obtained from the WIQ, and the participant cohort will be patients suffering from vascular-type claudication.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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South Yorkshire
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Sheffield, South Yorkshire, United Kingdom, S10 2BP
- Sheffield Hallam University
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Sheffield, South Yorkshire, United Kingdom, S5 7AU
- Sheffield Vascular Institute
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- ankle-brachial pressure index <0.9 on one or both legs
- presence of leg artery disease with exertional leg symptoms (claudication)
- age 18-90 years
Exclusion Criteria:
- inability to provide written, informed consent
- medical conditions that make exercise testing unsafe (e.g. unstable angina)
- comorbidities that limit walking performance to a greater extent than claudication symptoms
- unable to complete the tests involved in the study
Study Plan
How is the study designed?
Design Details
- Observational Models: Case-Only
- Time Perspectives: Cross-Sectional
Cohorts and Interventions
Group / Cohort |
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Intermittent claudication
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
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Treadmill maximum walking distance
Time Frame: 2 weeks
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2 weeks
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EACH-Q walking questionnaire score
Time Frame: 2 weeks
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2 weeks
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
WIQ walking questionnaire score
Time Frame: 2 weeks
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2 weeks
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Self-reported maximum walking distance
Time Frame: 2 weeks
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2 weeks
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6-minute maximum walking distance
Time Frame: 2 weeks
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2 weeks
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GPS-measured maximum walking distance
Time Frame: 2 weeks
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2 weeks
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Collaborators and Investigators
Investigators
- Principal Investigator: Garry A Tew, PhD, Sheffield Hallam University
- Principal Investigator: Pierre Abraham, MD, PhD, University Hospital of Angers, France
- Principal Investigator: Shah Nawaz, MD, Sheffield Teaching Hospitals NHS Foundation Trust
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- STH16036
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Intermittent Claudication
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Mid and South Essex NHS Foundation TrustRecruitingPeripheral Arterial Disease | Claudication, IntermittentUnited Kingdom
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Louis MessinaBioMarin PharmaceuticalRecruitingPeripheral Vascular Diseases | Peripheral Artery Disease | Claudication, IntermittentUnited States
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University Hospital, AngersCompletedPeripheral Artery Disease | Claudication, IntermittentFrance
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Palo Alto Veterans Institute for ResearchSociety for Vascular SurgeryWithdrawnPeripheral Artery Disease | Claudication, Intermittent
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Biotronik AGCompletedSevere Intermittent Claudication | Patients With Symptomatic Critical Limb IschemiaGermany
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University Hospital, EssenStraub Medical AGUnknownPeripheral Arterial Disease | Claudication, IntermittentGermany
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University Hospital, EssenUnknownPeripheral Arterial Disease | Claudication, IntermittentGermany
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Paradigm SpineCompletedIntermittent Neurogenic Claudication (INC) as a Result of Spinal StenosisNetherlands
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Imperial College LondonTerminatedStandardised Claudication Treadmill TestUnited Kingdom
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UCB PharmaCompletedStage II Peripheral Arterial Occlusive Disease | Intermittent Claudication Fontaine Stage II PAODGermany