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ISRCTN
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ISRCTN50793425
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ClinicalTrials.gov identifier
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Public title
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The effect of targeted exercise on falls and function for people with Parkinson's disease (Group Exercise Trial for Parkinson's disease - GET uP study)
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Scientific title
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Acronym
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Acronym added as of 28/06/2007: GET uP
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Serial number at source
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RDA/02/06/041
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Study hypothesis
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What is the effectiveness of a targeted exercise programme on reducing falls and improving the physical function of people with Parkinson's disease who have a history of falling?
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Ethics approval
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Devon and Torbay Research Ethics Committee, approved on 5 February 2007. Ref: 07/Q2102/8
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Study design
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Randomised, single-blind, controlled trial.
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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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Parkinson's disease
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Participants - inclusion criteria
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People diagnosed with Parkinson's disease who report two or more falls in the past year and who are independently mobile.
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Participants - exclusion criteria
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1. Needs supervision or assistance from another person to mobilise indoors
2. Significant comorbidity or symptoms that would affect ability or safety to participate in group exercise
3. Inability to follow written and verbal instructions in English
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Anticipated start date
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12/03/2007
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Anticipated end date
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30/04/2009
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Status of trial
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Ongoing
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Patient information material
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Target number of participants
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248
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Interventions
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A group based strength and balance exercise progamme, led by a physiotherapist plus additional home exercises versus usual care for 10 weeks.
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Primary outcome measure(s)
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Falls at 10 and 30 weeks post baseline/recruitment.
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Secondary outcome measure(s)
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1. Balance (Berg Balance scale)
2. Mobility (Timed Up and Go test)
3. Fear of falling (Falls efficacy scale - international)
4. Physical self-perception (physical self-perception profile)
5. Habitual physical activity, assessed using the "Phone - FITT" tool ("FITT" stands for Frequency, Intensity, Time, and Type of activity)
6. Quality of life (EQ-5D)
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Sources of funding
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Personal Award Scheme Researcher Development Award from National Institute of Health Research (UK) Ref: RDA/02/06/041
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Trial website
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Publications
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Contact name
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Mrs
Victoria
Goodwin
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Address
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Primary Care Research Group
Peninsula Medical School
Smeall Building
St Luke's Campus
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City/town
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Exeter
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Zip/Postcode
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EX1 2LU
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Country
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United Kingdom
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Tel
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+44 (0)1392 262745
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Fax
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+44 (0)1392 432223
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Email
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victoria.goodwin@pms.ac.uk
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Sponsor
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Peninsula Medical School (UK)
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Address
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c/o Professor John Campbell
Primary Care Research Group
Smeall Building
St Luke's Campus
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City/town
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Exeter
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Zip/Postcode
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EX1 2LU
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Country
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United Kingdom
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Sponsor website:
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http://www.pms.ac.uk/pms/
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Date applied
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08/03/2007
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Last edited
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06/08/2007
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Date ISRCTN assigned
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31/05/2007
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