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ISRCTN
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ISRCTN76180797
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ClinicalTrials.gov identifier
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Public title
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A comparison of upper-limb and lower-limb exercise training in patients with intermittent claudication (IC)
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Scientific title
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Acronym
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N/A
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Serial number at source
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PG/2000042
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Study hypothesis
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Upper-limb aerobic exercise training will be as effective as lower-limb aerobic exercise training for evoking symptomatic improvements in patients with symptomatic peripheral arterial disease (PAD).
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Lay summary
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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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Peripheral arterial disease.
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Participants - inclusion criteria
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Patients with stable intermittent claudication were recruited from the Sheffield Vascular Institute at the Northern General Hospital, Sheffield, UK. The clinical diagnosis of PAD was established using the patient’s history and a physical examination, and was confirmed by the Doppler assessment of ankle-brachial pressure index (ABPI), a non-invasive reliable measure of lower-extremity hemodynamics, in accordance with current UK medical practice.
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Participants - exclusion criteria
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Patients experiencing symptoms of IC for less than 12 months, or reporting a significant change in walking ability within this time period were considered to have unstable disease and were, as a consequence, excluded. Patients were also excluded if they exhibited features of critical ischemia, had undergone a re-vascularization procedure within the previous 12 months, or if initial assessment established that they suffered from severe arthritis (i.e. if they were unable to walk unaided or perform either upper- or lower limb cranking exercise due to joint pain), severe lumbar spine disease or unstable cardiorespiratory conditions (i.e. unstable blood pressure, recent electrocardiographic changes or acute myocardial infarction, unstable angina, third-degree heart block, acute congestive heart failure and severe respiratory conditions).
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Anticipated start date
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01/10/2000
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Anticipated end date
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31/12/2005
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Status of trial
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Completed |
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Patient information material
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Target number of participants
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104
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Interventions
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Upper- versus lower-limb aerobic exercise training. Supervised training sessions were held twice weekly for 6 weeks with arm cranking or leg cranking.
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Primary outcome measure(s)
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Walking performance (claudication distance and maximum walking distance).
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Secondary outcome measure(s)
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1. Upper- and lower-limb aerobic exercise capacity
2. Disease-specific and generic quality of life measures
3. Blood markers of cardiovascular disease risk
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Sources of funding
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British Heart Foundation (UK) - (Grant number: PG/2000042)
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Trial website
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Publications
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1. 2005 results in http://www.ncbi.nlm.nih.gov/pubmed/16376202
2. 2006 results in http://www.ncbi.nlm.nih.gov/pubmed/16095931
3. 2008 results in http://www.ncbi.nlm.nih.gov/pubmed/18226561
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Contact name
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Dr
John
Saxton
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Address
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Centre for Sport and Exercise Science
Sheffield Hallam University
Collegiate Crescent Campus
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City/town
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Sheffield
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Zip/Postcode
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S10 2BP
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Country
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United Kingdom
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Tel
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+44 (0)114 225 4414
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Fax
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+44 (0)114 225 4341
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Email
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j.m.saxton@shu.ac.uk
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Sponsor
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Sheffield Hallam University (UK)
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Address
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City Campus
Howard Street
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City/town
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Sheffield
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Zip/Postcode
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S1 1WB
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Country
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United Kingdom
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Tel
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+44 (0)114 225 5555
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Email
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liaison@shu.ac.uk
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Sponsor website:
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http://www.shu.ac.uk
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Date applied
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24/08/2005
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Last edited
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28/07/2010
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Date ISRCTN assigned
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25/10/2005
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