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| [ Print-friendly version ] |
| SEDRIC – Structured EDucation for Rehabilitation in Intermittent Claudication |
| ISRCTN | ISRCTN06733130 |
| DOI | 10.1186/ISRCTN06733130 |
| ClinicalTrials.gov identifier | NCT01776710 |
| EudraCT number | |
| Public title | SEDRIC – Structured EDucation for Rehabilitation in Intermittent Claudication |
| Scientific title | Development and piloting of a pragmatic structured education programme that promotes walking in patients with intermittent claudication |
| Acronym | SEDRIC |
| Serial number at source | 13928 |
| 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. More details can be found at: http://public.ukcrn.org.uk/Search/StudyDetail.aspx?StudyID=13928 |
| Lay 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 When is the study starting and how long is it expected to run for? The study is starting in March 2013 and is expected to end in August 2013. Who is funding the study? Bupa Foundation Who is the main contact? Dr Garry Tew g.tew@shu.ac.uk |
| Ethics approval | NRES Committee Yorkshire & The Humber – Sheffield, 25/01/2013, ref: 13/YH/0004 |
| Study design | Interventional and Observational; Design type: Treatment, Qualitative |
| Countries of recruitment | United Kingdom |
| Disease/condition/study domain | Topic: Cardiovascular; Subtopic: Cardiovascular (all Subtopics); Disease: Cardiovascular |
| Participants - 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 |
| Participants - 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) |
| Anticipated start date | 01/03/2013 |
| Anticipated end date | 31/08/2013 |
| Status of trial | Ongoing |
| Patient information material | Not available in web format, please use the contact details below to request a patient information sheet |
| Target number of participants | UK Sample Size: 55 |
| Interventions | 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. |
| Primary outcome measure(s) | Feasibility (recruitment, retention, compliance, acceptability) Timepoint(s): Baseline and 6 weeks |
| Secondary outcome measure(s) |
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 |
| Sources of funding | Bupa Foundation (UK) |
| Trial website | |
| Publications | |
| Contact name | Dr Garry Tew |
| Address |
Centre for Sport and Exercise Science
Sheffield Hallam University A125 Collegiate Hall Collegiate Crescent |
| City/town | Sheffield |
| Zip/Postcode | S10 2BP |
| Country | United Kingdom |
| g.tew@shu.ac.uk | |
| Sponsor | Sheffield Hallam University (UK) |
| Address |
c/o Brian Littlejohn
The Centre for Sport and Exercise Science Faculty of Health and Wellbeing City Campus Howard Street |
| City/town | Sheffield |
| Zip/Postcode | S1 1WB |
| Country | United Kingdom |
| Sponsor website: | http://www.shu.ac.uk/ |
| Date applied | 28/02/2013 |
| Last edited | 01/03/2013 |
| Date ISRCTN assigned | 28/02/2013 |
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