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ISRCTN
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ISRCTN93377248
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ClinicalTrials.gov identifier
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Public title
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The effect of vibration therapy on bowel stimulation in elderly patients with dementia - a pilot study
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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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N0081063466
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Study hypothesis
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To examine the claim that vibration, when used regularly over a period of months can help to restore normal bowel function to persons needing medical intervention for severe constipation.
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Ethics approval
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Not provided at time of registration
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Study design
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Randomised controlled cross-over pilot study
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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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Digestive System: Constipation
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Participants - inclusion criteria
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Long-stay elderly patients (at least 20) on selected ward/nursing home areas who have moderate to severe dementia and who have constipation requiring regular laxative therapy.
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Participants - exclusion criteria
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1. Failure to give consent
2. Withdrawn if therapy too distressing
3. Withdrawn if too ill to continue
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Anticipated start date
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01/02/2000
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Anticipated end date
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14/12/2005
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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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20
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Interventions
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Randomised controlled cross-over trial over twelve months. Vibration therapy will be administered via vibration pads and the effects assessed for each participant for six months with the intervention in place, and six months when it is not offered. Vibration therapy will involve patients using the pads 3 times a week for 40 minute sessions.
Group 1: Vibration for 6 months then no intervention
Group 2: No intervention, then vibration for 6 months.
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Primary outcome measure(s)
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1. Frequency of bowel movement
2. Enema/laxative use for participants
3. Recording of adverse effects
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Secondary outcome measure(s)
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Not provided at time of registration
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Sources of funding
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Leicestershire Partnership NHS Trust
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Trial website
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Publications
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Contact name
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Mrs
Lesley
Haig
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Address
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Elderly Directorate
Leicestershire Partnership NHS Trust
Towers Hospital
Gipsy Lane
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City/town
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Leicester
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Zip/Postcode
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LE5 0TD
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Country
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United Kingdom
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Sponsor
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Record Provided by the NHSTCT Register - 2007 Update - Department of Health
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Address
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The Department of Health, Richmond House, 79 Whitehall
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City/town
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London
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Zip/Postcode
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SW1A 2NL
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Country
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United Kingdom
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Tel
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+44 (0)20 7307 2622
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Fax
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+44
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Email
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dhmail@doh.gsi.org.uk
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Sponsor website:
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http://www.dh.gov.uk/Home/fs/en
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Date applied
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28/09/2007
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Last edited
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06/11/2007
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Date ISRCTN assigned
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28/09/2007
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