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ISRCTN
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ISRCTN53367487
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ClinicalTrials.gov identifier
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Public title
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Effects of an eight-month aquatic exercise programme in women with fibromyalgia
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Scientific title
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Acronym
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AF8PF/18/02
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Serial number at source
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18/02
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Study hypothesis
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1. Aquatic exercise improves the health-related quality of life and physical fitness
2. Aquatic training is a cost-effective strategy in persons with fibromyalgia
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Ethics approval
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Bioethical Committee of the University of Extremadura on 11/07/2002, reference number 18/02
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Study design
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Randomised controlled trial
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Countries of recruitment
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Spain
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Disease/condition/study domain
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Fibromyalgia
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Participants - inclusion criteria
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Women who suffer fibromyalgia according to diagnosis by the American College of Rheumatism
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Participants - exclusion criteria
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1. Contraindications to physical exercise
2. Other physical or psychological therapies
3. Cognitive disease
4. Drugs affecting the measures
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Anticipated start date
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01/10/2004
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Anticipated end date
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01/06/2005
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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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33 distributed in two groups
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Interventions
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Aquatic training, three sessions per week for eight months
In the eight-month fibromyalgia trial, there were two groups:
1. Control group: usual care (primary care based on antidepressants) without adding any physical or psychological therapy
2. Intervention group: we added three one-hour aquatic training sessions including:
a. 4x12 knee flexo extension using body weight as charge
b. 4x12 upper limb movements against the water drag using a pull-boy
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Primary outcome measure(s)
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1. Pain as measured by the visual analogue scale (VAS)
2. EuroQol 5-D
3. Short-form-36 questionnaire (SF-36) scores
4. Utility and costs
Isokinetic strength and electromyographic parameters
Fibromyalgia Impact Questionnaire
Fitness
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Secondary outcome measure(s)
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Phychological aspects: state trait anxiety inventory
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Sources of funding
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Health Department of Junta de Extremadura (Spain)
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Trial website
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Publications
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1. 2008 results in http://www.ncbi.nlm.nih.gov/pubmed/18294367
2. 2009 results in http://www.ncbi.nlm.nih.gov/pubmed/19605373
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Contact name
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Prof
Narcis
Gusi
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Address
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Faculty of Sports Sciences
Avda Universidad s/n
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City/town
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Caceres
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Zip/Postcode
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10071
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Country
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Spain
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Tel
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+34 (0)92 725 74 60
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Fax
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+34 (0)92 725 74 61
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Email
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ngusi@unex.es
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Sponsor
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University of Extremadura (Spain)
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Address
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Avda Elvas s/n
Badajoz
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City/town
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Caceres
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Zip/Postcode
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06071
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Country
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Spain
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Tel
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+34 (0)92 428 93 05
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Fax
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+34 (0)92 427 29 83
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Email
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vicein@unex.es
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Sponsor website:
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http://www.unex.es
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Date applied
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18/06/2006
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Last edited
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20/07/2009
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Date ISRCTN assigned
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14/07/2006
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