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ISRCTN
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ISRCTN21695765
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ClinicalTrials.gov identifier
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Public title
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Cost-effectiveness of a proprioceptive exercise program in institutionalised elderly with fear of falling
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Scientific title
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Cost-effectiveness of a proprioceptive exercise program in institulionalised elderly with fear of falling: randomised controlled trial
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Acronym
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N/A
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Serial number at source
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N/A
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Study hypothesis
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1. Proprioceptive exercise program will reduce fear of falling in institutionalised elderly with fear of falling
2. Proprioceptive exercise program will improve static and dynamic balance in institutionalised elderly with fear of falling
3. Proprioceptive exercise program will reduce the risk of falling in institutionalised elderly with fear of falling
4. Proprioceptive exercise program is a cost-effective addition to usual care in in institutionalised elderly with fear of falling
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Lay summary
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Ethics approval
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Biomedical Ethical Committee of the University of Extremadura approved on the 16th June 2010 (ref: 30/2010)
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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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Fear of falling
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Participants - inclusion criteria
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1. Patients with fear of falling (Falls Efficacy Scale International [FES-I] Score, 16 item questionnaire, greater than 23)
2. Institutionalised people
3. Informed consent
4. Aged 65 years and older, male and female
5. Ability to understand instructions
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Participants - exclusion criteria
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1. To have an artificial prosthesis
2. Other physical or psychological therapies different from usual care in the National Health Service and the nursing home
3. Show symptoms during the medical examination to recommend their exclusion
4. Cognitive disease
5. Any drug intake that may affect balance significantly - to avoid external influences
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Anticipated start date
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01/07/2010
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Anticipated end date
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01/10/2010
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Status of trial
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Completed |
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Patient information material
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Not available in web format, please use contact details below to request a patient information sheet
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Target number of participants
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50
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Interventions
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The participants will be randomly assigned to intervention or control group by a random table built by computer:
1. Interventional group: three-month progressive proprioceptive exercise program, applied twice a week
2. Control group: care as usual
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Primary outcome measure(s)
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Measured at baseline and three months:
1. Falls Efficacy Scale International (FES-I)
2. Balance (Fall risk and postural stability) measured by Biodex Balance
2. Muscular function (isokinetic measurements) measured by System-3 Biodex Dynamometer
3. Health related quality of life:
3.1. EuroQol EQ-5D Instrument (utility index)
3.2. 36-item Short Form Health Survey (SF-36) (utility index)
4. Fitness
5. Health system and societal costs
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Secondary outcome measure(s)
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Measured at baseline and three months:
1. Grade of satisfaction with programme
2. Weight, % fat
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Sources of funding
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University of 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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Av de la Universidad, s/n
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City/town
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Cáceres
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Zip/Postcode
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10003
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Country
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Spain
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Sponsor
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University of Extremadura (Spain)
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Address
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Av de 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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Sponsor website:
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http://www.unex.es/
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Date applied
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28/06/2010
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Last edited
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06/07/2010
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Date ISRCTN assigned
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06/07/2010
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