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ISRCTN
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ISRCTN90757358
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ClinicalTrials.gov identifier
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Public title
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Mild to moderate claudication: the cost-effectiveness of supervised exercise programmes in patient management.
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Scientific title
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Acronym
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EXACT
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Serial number at source
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HTA 99/22/08
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Study hypothesis
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The main objectives of the study are as follows:
1. To compare outcomes for the following treatment strategies for patients with mild to moderate claudication:
1.1. Angioplasty (i.e. status quo treatment)
1.2. Supervised exercise programme
1.3. Exercise and lifestyle advice only (control)
2. To measure the cost of each strategy, including treatment and subsequent health care costs, over 3 years
3. To compare costs and short-term to medium-term (6 months - 3 year) outcomes in different patient groups
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Ethics approval
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Not provided at time of registration
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Study design
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Randomised controlled trial
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Countries of recruitment
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United Kingdom
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Disease/condition/study domain
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Cardiovascular diseases: peripheral arterial disease
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Participants - inclusion criteria
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Patients with claudication
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Participants - exclusion criteria
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Not provided at time of registration
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Anticipated start date
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01/09/2001
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Anticipated end date
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31/05/2005
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Status of trial
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Stopped
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Patient information material
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Target number of participants
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Not provided at time of registration
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Interventions
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1. Angioplasty (i.e. status quo treatment)
2. Supervised exercise programme.
3. Exercise and lifestyle advice only (control)
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Primary outcome measure(s)
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Not provided at time of registration
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Secondary outcome measure(s)
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Not provided at time of registration
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Sources of funding
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NIHR Health Technology Assessment Programme - HTA (UK)
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Trial website
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Publications
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2006 results in http://www.ncbi.nlm.nih.gov/pubmed/16414385
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Contact name
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Dr
Brian
McCloskey
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Address
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Department of Psychology
Health & Social Care
University College Worcester
Henwick Grove
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City/town
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Worcester
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Zip/Postcode
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WR2 6AJ
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Country
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United Kingdom
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Tel
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+44 (0)1905 760023
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Fax
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+44 (0)1905 28672
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Email
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brian.mccloskey@worc.ac.uk
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Sponsor
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Department of Health (UK)
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Address
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Quarry House
Quarry Hill
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City/town
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Leeds
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Zip/Postcode
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LS2 7UE
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Country
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United Kingdom
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Email
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Sheila.Greener@doh.gsi.gov.uk
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Sponsor website:
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http://www.dh.gov.uk/en/index.htm
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Date applied
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25/04/2003
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Last edited
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31/12/2008
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Date ISRCTN assigned
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25/04/2003
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