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ISRCTN
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ISRCTN83162243
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ClinicalTrials.gov identifier
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Public title
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Physical activity to persons with fibromyalgia and osteoporosis
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Scientific title
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Acronym
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AFPFO/05/02
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Serial number at source
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05/02
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Study hypothesis
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1. Physical activity enhances the
health related to quality of life and physical fitness
2. Aquatic training is a cost-effective strategy in persons with fibromyalgia
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Lay summary
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Ethics approval
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Approved by the Bioethical Committee of University of Extremadura on 10/02/2002 ( ref: 05/02)
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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 American College of Rheumatism diagnosis
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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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01/04/2004
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Anticipated end date
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01/10/2004
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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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65 distributed in three groups
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Interventions
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Patients are randomised to three groups:
Group 1: Aquatic training, 3 sessions per week for 3 months - 18 patients
Group 2: Usual care - 17 patients
Group 3: Land-based training, 3 sessions per week for 3 months - 30 patients
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Primary outcome measure(s)
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Group 1 versus Group 2 = Isokinetic strength and electromyographic parameters, health related quality of life -Fibromyalgia Impact Questionnaire, EQ5D and SF-36 and its utilities to study cost-effectiveness, fitness, costs
Group 1 versus Group 3 = Health related quality of life -Fibromyalgia Impact Questionnaire, EQ5D and SF-36 and its utilities to study cost-effectiveness, fitness, costs
Group 2 versus Group 3 = Health related quality of life -Fibromyalgia Impact Questionnaire, EQ5D and SF-36 and its utilities to study cost-effectiveness, fitness, costs
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Secondary outcome measure(s)
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Group 1 versus Group 2 = Psychological aspects - State Trait Anxiety Inventory
Group 1 versus Group 3 = Psychological aspects - State Trait Anxiety Inventory
Group 2 versus Group 3 = Psychological 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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Contact name
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Prof
Narcis
Gusi
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Address
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Faculty of Sports Sciences
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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
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City/town
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Badajoz
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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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04/03/2006
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Last edited
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05/11/2009
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Date ISRCTN assigned
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20/04/2006
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