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.
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
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.
- Conditions
- Intermittent 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 group | Role | What they receive |
|---|---|---|
| Intermittent claudication | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treadmill maximum walking distance
Measured: 2 weeks
EACH-Q walking questionnaire score
Measured: 2 weeks
Secondary outcomes (4)
WIQ walking questionnaire score
Measured: 2 weeks
Self-reported maximum walking distance
Measured: 2 weeks
6-minute maximum walking distance
Measured: 2 weeks
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.
- First posted2 Dec 2011 (estimated)
- Study startJun 2011
- Primary completionMay 2012
- Study completionMay 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Intermittent ClaudicationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Sheffield Teaching Hospitals NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- Sheffield Hallam University, University Hospital, Angers, Imperial College London
- Responsible party
- Sponsor
- Investigators
- Garry A Tew, PhD, Principal investigator, Sheffield Hallam UniversityPierre Abraham, MD, PhD, Principal investigator, University Hospital of Angers, FranceShah Nawaz, MD, Principal investigator, Sheffield Teaching Hospitals NHS Foundation Trust
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
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01484509
- Acronym / sponsor ID
- STH16036
- Conditions
- Intermittent Claudication
- Keywords
- walking impairment, claudication, treadmill, questionnaire
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- Sheffield Teaching Hospitals NHS Foundation TrustUniversity, hospital or other
- Collaborators
- Sheffield Hallam University, University Hospital, Angers, Imperial College London
- Study start
- Jun 2011
- Primary completion
- May 2012 (actual)
- Study completion
- May 2012 (actual)
- First posted
- 2 Dec 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intermittent claudication | – | – |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with intermittent claudication recruited from hospital clinics
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Treadmill maximum walking distance
Time frame: 2 weeks
EACH-Q walking questionnaire score
Time frame: 2 weeks
4 secondary outcomes
WIQ walking questionnaire score
Time frame: 2 weeks
Self-reported maximum walking distance
Time frame: 2 weeks
6-minute maximum walking distance
Time frame: 2 weeks
GPS-measured maximum walking distance
Time frame: 2 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2012.
- Derived from this study: PubMed 23384490Tew 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.
Related trials for Intermittent Claudication
Not yet recruiting
Daily Stretching to Improve Walking in Older Patients With Peripheral Artery Disease: The STRETCH PAD Study
Peripheral Artery Disease (PAD), Intermittent Claudication
Recruiting
EVERO Drug-coated Balloon (DCB) Randomized Trial
Peripheral Vascular Disease, Peripheral Arterial Disease
Recruiting
Personalised Multicomponent Exercise Programme in Peripheral Arterial Disease
Peripheral Arterial Disease, Intermittent Claudication
Active, not recruitingPhase 4
Ramipril Treatment of Claudication: Oxidative Damage and Muscle Fibrosis
Peripheral Arterial Disease
RecruitingPhase 3
Improving Mobility After Revascularization in Peripheral Artery Disease
Peripheral Artery Disease, Intermittent Claudication
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Garry A Tew, PhD principal investigator
Sheffield Hallam University
Pierre Abraham, MD, PhD principal investigator
University Hospital of Angers, France
Shah Nawaz, MD principal investigator
Sheffield Teaching Hospitals NHS Foundation Trust
2 sites in 1 country: see every site and its status.
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.