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ISRCTN
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ISRCTN76235671
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ClinicalTrials.gov identifier
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Public title
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Vibratory exercise to prevent falls and osteoporosis in older women in primary care
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Scientific title
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Acronym
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EVCOM/15/04
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Serial number at source
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15/04
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Study hypothesis
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1. Vibratory exercise reduces bone loss more than walk-based exercise
2. Vibratory exercise maintains the fitness (balance, lower limbs strength etc.) more than walk-based exercise
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Lay summary
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Ethics approval
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Bioethical Committee of the University of Extremadura on 15/09/2004, reference number 15/04
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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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Prevention of falls and osteoporosis in postmenopausal women
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Participants - inclusion criteria
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Women older than 60 years old
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Participants - exclusion criteria
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1. Contraindications to physical exercise
2. Disease or drugs treatment that could influence measures such as bone metabolism or strength
3. Other physical or psychological therapies
4. Cognitive disease
5. Nutritional deficit in vitamin D or calcium
6. Smoking or alcohol consumption
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Anticipated start date
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01/11/2004
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Anticipated end date
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01/07/2005
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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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36
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Interventions
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1. Intervention group: eight months of vibratory exercise
2. Control group: eight months of walk-based exercise
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Primary outcome measure(s)
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1. Bone mass density (dual energy x-ray absorptiometry [DEXA] technique)
2. Fitness (balance, isokinetic strength, vertical jump, walking speed, stairs climbing)
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Secondary outcome measure(s)
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Health-related quality of life (EQ-5D, short-form-36 questionnaire [SF-36])
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Sources of funding
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Health Department of Junta de Extremadura: Sociosanitary Research (SCSS0466) - Spain
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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/17137514
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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
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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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18/06/2006
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Last edited
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28/10/2008
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Date ISRCTN assigned
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14/07/2006
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