Subjective and Objective Methods of Assessing Walking Limitation Due to Claudication

NCT01484509 | Completed DMC

• 1 other identifier: STH16036
• Study Type: observational
• Target: 37
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Intermittent Claudication

Keywords

walking impairment; claudication; treadmill; questionnaire

Outcome Measures

Primary Outcomes (2)

• Treadmill maximum walking distance

  2 weeks

• EACH-Q walking questionnaire score

  2 weeks

Secondary Outcomes (4)

• WIQ walking questionnaire score

  2 weeks

• Self-reported maximum walking distance

  2 weeks

• 6-minute maximum walking distance

  2 weeks

• GPS-measured maximum walking distance

  2 weeks

Study Arms (1)

Intermittent claudication

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with intermittent claudication recruited from hospital clinics

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sheffield Teaching Hospitals NHS Foundation Trust: lead
• Sheffield Hallam University: collaborator
• University Hospital, Angers: collaborator
• Imperial College London: collaborator

Study Sites (2)

Sheffield Hallam University

Sheffield, South Yorkshire, S10 2BP, United Kingdom

Location

Sheffield Vascular Institute

Sheffield, South Yorkshire, S5 7AU, United Kingdom

Location

Related Publications (1)

• Tew G, Copeland R, Le Faucheur A, Gernigon M, Nawaz S, Abraham P. Feasibility and validity of self-reported walking capacity in patients with intermittent claudication. J Vasc Surg. 2013 May;57(5):1227-34. doi: 10.1016/j.jvs.2012.02.073. Epub 2013 Feb 4.

  PMID: 23384490 DERIVED

MeSH Terms

Conditions

Intermittent Claudication

Condition Hierarchy (Ancestors)

Peripheral Arterial Disease; Peripheral Vascular Diseases; Vascular Diseases; Cardiovascular Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 24, 2011
• First Posted: December 2, 2011
• Study Start: June 1, 2011
• Primary Completion: May 1, 2012
• Study Completion: May 1, 2012
• Last Updated: May 15, 2012

Record last verified: 2011-11

Locations

GB (2)