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Intermittent ClaudicationNCT01484509

Subjective and Objective Methods of Assessing Walking Limitation Due to Claudication

An observational study of Intermittent Claudication, run by Sheffield Teaching Hospitals NHS Foundation Trust at 2 sites in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 90 years
Conditions the study is for
Intermittent Claudication
How many people
37 participants
Where
2 sitesUnited Kingdom
Study dates
Jun 2011to 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 18 to 90 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Patients with intermittent claudication recruited from hospital clinics

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

2 sites in 1 country.

United Kingdom2 sites
  • Sheffield Hallam University

    Sheffield, South Yorkshire, S10 2BP

  • Sheffield Vascular Institute

    Sheffield, South Yorkshire, S5 7AU

Other trials in United Kingdom

About this study

Official title: 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.

Read the 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.

Keywords
walking impairment, claudication, treadmill, questionnaire
Medical subject headings
Intermittent Claudication

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT01484509
Study groupRoleWhat they receive
Intermittent claudicationNot described

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Treadmill maximum walking distance

    Measured: 2 weeks

  2. EACH-Q walking questionnaire score

    Measured: 2 weeks

Secondary outcomes (4)
  1. WIQ walking questionnaire score

    Measured: 2 weeks

  2. Self-reported maximum walking distance

    Measured: 2 weeks

  3. 6-minute maximum walking distance

    Measured: 2 weeks

  4. GPS-measured maximum walking distance

    Measured: 2 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Dec 2011 (estimated)
  2. Study startJun 2011
  3. Primary completionMay 2012
  4. Study completionMay 2012

Resources

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
Case only
Time perspective
Cross-sectional
Enrolment
37 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01484509
Sponsor's protocol ID
STH16036
Status last verified
Nov 2011
First submitted
24 Nov 2011
Last updated
15 May 2012
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 23384490

Questions about this trial

What is this clinical trial studying?

An observational study of Intermittent Claudication, run by Sheffield Teaching Hospitals NHS Foundation Trust at 2 sites in United Kingdom.

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 3 inclusion and 4 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: finished, as of the sponsor's last update on 15 May 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United Kingdom. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Treadmill maximum walking distance (time frame: 2 weeks). The study lists 2 primary outcomes in all. 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 NCT01484509, which also lists 1 linked publication.

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 15 May 2012.

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