Condition category
Circulatory System
Date applied
28/02/2013
Date assigned
28/02/2013
Last edited
16/05/2016
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Some people experience a cramp-like leg pain during walking that is relieved only by rest. This is called intermittent claudication and it is a common symptom of peripheral arterial disease. Patients with intermittent claudication struggle to walk, which in turn lowers their quality of life. Medically supervised walking programmes have been shown to improve walking ability and quality of life, but more patients could potentially benefit from physical activity that is self-managed and performed in the community setting. However, little is known about the usefulness of education programmes that promote self-managed physical activity in these patients. This research project aims to develop and test a practical education programme for promoting walking activity in patients with intermittent claudication. We will collect scientific data on the programme's usefulness.

Who can participate?
Men and women aged 18-90 years with intermittent claudication.

What does the study involve?
Twenty five patients with intermittent claudication will be interviewed to inform the development of the education programme. At least 12 patients will test the programme to see if any changes are needed. Once we are satisfied with the design of the programme, we will assess the usefulness of the programme in a further 30 patients, who will be randomly assigned to receive either the education programme or usual care.

What are the possible benefits and risks of participating?
Possible benefits of the programme include an increased understanding about peripheral arterial disease. They will also receive support in developing goals and action plans for walking more often, which if adhered to, may result in improved walking capacity and quality of life. All participants will also receive a medical "check-up" from a Consultant Vascular Surgeon during the eligibility screening. Results from this research will help us plan a much larger trial across several UK institutions. During exertion, there is an increased risk of untoward cardiovascular events such as heart attack. The likelihood of this happening, however, is small. We will minimise the risk of this by only recruiting patients who do not have unstable cardiovascular conditions, by using 12-lead ECG monitoring before, during and after the test, and by ensuring that all tests are supervised by a clinician and a clinical exercise physiologist. We will make it possible for patients to see a Consultant Vascular Surgeon at any point during the trial, if they or the study team have any medical concerns.

Where is the study run from?
Sheffield Hallam University (UK)

When is the study starting and how long is it expected to run for?
March 2013 to August 2013

Who is funding the study?
Bupa Foundation

Who is the main contact?
Dr Garry Tew
g.tew@shu.ac.uk

Trial website

Contact information

Type

Scientific

Primary contact

Dr Garry Tew

ORCID ID

Contact details

Centre for Sport and Exercise Science
Sheffield Hallam University
A125 Collegiate Hall
Collegiate Crescent
Sheffield
S10 2BP
United Kingdom
-
g.tew@shu.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

NCT01776710

Protocol/serial number

13928

Study information

Scientific title

Development and piloting of a pragmatic structured education programme that promotes walking in patients with intermittent claudication

Acronym

SEDRIC

Study hypothesis

Some people experience a cramp-like leg pain during walking that is relieved only by rest. This is called intermittent claudication and it is a common symptom of peripheral arterial disease. Patients with intermittent claudication struggle to walk, which in turn lowers their quality of life. Medically supervised walking programmes have been shown to improve walking ability and quality of life, but more patients could potentially benefit from physical activity that is self-managed and performed in the community setting. However, little is known about the usefulness of education programmes that promote self-managed physical activity in these patients. This research project aims to develop and test a practical education programme for promoting walking activity in patients with intermittent claudication. We will collect scientific data on the programme's usefulness.

Twenty five patients with intermittent claudication will be interviewed to inform the development of the education programme. At least 12 patients will test the programme to see if any changes are needed. Once we are satisfied with the design of the programme, we will assess the usefulness of the programme in 18 patients. In total, 30 patient volunteers will be randomly assigned to receive either the education programme or usual care.

Possible benefits of the programme to be explored include increased daily steps/physical activity, and improved walking capacity and quality of life. Patients will be followed up until 6 weeks after being allocated to intervention or control groups. Encouraging results from this research will help us plan a much larger trial across several UK institutions.

Ethics approval

NRES Committee Yorkshire & The Humber – Sheffield, 25/01/2013, ref: 13/YH/0004

Study design

Interventional and Observational; Design type: Treatment, Qualitative

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Topic: Cardiovascular; Subtopic: Cardiovascular (all Subtopics); Disease: Cardiovascular

Intervention

Structured education programme, The structured education intervention will comprise a 3-hour education workshop delivered by two trained facilitators and a follow-up telephone call 2 weeks later. The aims of the education programme are to enhance patients' understanding of peripheral arterial disease and intermittent claudication, and to support patients in increasing their daily walking activity. Key behaviour change techniques that will be incorporated will include goal setting, action planning, barrier identification/problem.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Feasibility (recruitment, retention, compliance, acceptability) Timepoint(s): Baseline and 6 weeks

Secondary outcome measures

1. Claudication onset and maximum walking distances on 6-minute corridor walk test; Timepoint(s): Baseline and 6 weeks
2. Claudication onset and maximum walking distances on incremental treadmill walking test; Timepoint(s): Baseline and 6 weeks
3. Daily steps and physical activity; Timepoint(s): Baseline and 6 weeks
4. Health-related quality of life; Timepoint(s): Baseline and 6 weeks
5. Psychological constructs representing the key mediators of behaviour change; Timepoint(s): Baseline and 6 weeks 6. Self-reported ambulatory ability; Timepoint(s): Baseline and 6 weeks

Overall trial start date

25/04/2013

Overall trial end date

25/04/2014

Reason abandoned

Eligibility

Participant inclusion criteria

1. Men and women aged 18-90 years with intermittent claudication due to peripheral arterial disease
2. Stable disease for >3 months
3. Able to provide consent
4. Able to read and speak English to a level allowing satisfactory completion of written questionnaires and to participate in the education intervention

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

UK Sample Size: 55

Participant exclusion criteria

1. Previous endovascular/surgical interventions
2. Scheduled endovascular/surgical intervention
3. Critical limb ischaemia
4. Those whose function is uniquely impaired, e.g. wheelchair-bound patients and patients with lower-extremity amputation(s).
5. Presence of contraindications to exercise or co-morbidities that limit exercise performance to a greater extent than the intermittent claudication (e.g. severe arthritis)
6. Major surgery, myocardial infarction or stroke/TIA in the previous 6 months
7. Patients who already perform greater than 30 min of structured exercise three times weekly (self-reported)

Recruitment start date

25/04/2013

Recruitment end date

25/04/2014

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Sheffield Hallam University
Sheffield
S10 2BP
United Kingdom

Sponsor information

Organisation

Sheffield Hallam University (UK)

Sponsor details

c/o Brian Littlejohn
The Centre for Sport and Exercise Science
Faculty of Health and Wellbeing
City Campus
Howard Street
Sheffield
S1 1WB
United Kingdom

Sponsor type

University/education

Website

http://www.shu.ac.uk/

Funders

Funder type

Charity

Funder name

Bupa Foundation (UK)

Alternative name(s)

Funding Body Type

private sector organisation

Funding Body Subtype

foundation

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2015 results in: http://www.ncbi.nlm.nih.gov/pubmed/25858012

Publication citations

Additional files

Editorial Notes

16/05/2016: Publication reference added. 25/04/2013: the following changes were made to the trial record: 1. The overall trial start date was updated from 01/03/2013 to 25/04/2013. 2. The overall trial end date was updated from 31/08/2014 to 25/04/2014.