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ISRCTN
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ISRCTN71091471
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ClinicalTrials.gov identifier
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Public title
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The prevalence and associations of fatigue in Systemic Lupus Erythematosus (SLE) and the effects of aerobic exercise on fatigue and sleep patterns in SLE
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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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T0519
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Study hypothesis
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To test the efficacy of a graded aerobic exercise programme in treating fatigue in systemic lupus erythematosus.
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Ethics approval
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Ethical approval was obtained from the district research ethics committee and all subjects gave valid and informed consent before entering the study.
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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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Systemic lupus erythematosus (SLE)
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Participants - inclusion criteria
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Female patients fulfilling American College of Rheumatology (ACR) classification for SLE
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Participants - exclusion criteria
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1. Evidence of active severe myositis, nephritis, neurological involvement or cardiac or pulmonary disease
2. Pregnant patients
3. Patients under 16 or over 55 years
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Anticipated start date
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01/01/2001
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Anticipated end date
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01/01/2003
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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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93
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Interventions
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Allocation using a minimisation protocol to 12 weeks of either graded exercise therapy, relaxation therapy or no intervention
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Primary outcome measure(s)
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Self-rated clinical global impression change score, measured at baseline and three months.
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Secondary outcome measure(s)
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1. Assessments of symptoms, measured at baseline and three months
2. Functional capacity, measured at baseline and three months
3. Fitness, measured at baseline and three months
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Sources of funding
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Arthritis Research Campaign (UK)
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Trial website
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Publications
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Results in http://www.ncbi.nlm.nih.gov/sites/entrez?cmd=retrieve&db=pubmed&list_uids=12730519
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Contact name
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Dr
David
D'Cruz
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Address
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The Lupus Research Unit
The Rayne Institute
St Thomas' Hospital
Lambeth Palace Road
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City/town
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London
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Zip/Postcode
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SE1 7EH
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Country
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United Kingdom
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Sponsor
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Arthritis Research Campaign (ARC) (UK)
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Address
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Copeman House
St Mary's Court
St Mary's Gate
Chesterfield
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City/town
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Derbyshire
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Zip/Postcode
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S41 7TD
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Country
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United Kingdom
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Email
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info@arc.org.uk
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Sponsor website:
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http://www.arc.org.uk
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Date applied
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18/07/2002
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Last edited
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13/03/2008
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Date ISRCTN assigned
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18/07/2002
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