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ISRCTN
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ISRCTN63503875
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ClinicalTrials.gov identifier
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Public title
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Randomised controlled trial of a home-based exercise programme to reduce fall frequency among people with Parkinson's disease (PD)
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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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AP0888
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Study hypothesis
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To evaluate the effectiveness of a personalised home programme of exercises and strategies for repeat fallers with Parkinson's disease (PD).
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Lay summary
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Ethics approval
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East Dorset Local Research Ethics Committee gave approval in March 2001 (ref: 13/00/S)
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Study design
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Randomised 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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1. Diagnosed with PD living in the community
2. Independently mobile
3. Have experienced two or more falls in the previous 12 months
4. Have passed a screen test for confusion
5. Aged 44 - 91 years, both sexes
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Participants - exclusion criteria
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1. Did not meet inclusion criteria
2. Unable to participate in assessments because of pain and acute medical condition
3. In receipt of, or soon to receive, treatment
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Anticipated start date
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01/01/2004
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Anticipated end date
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01/01/2007
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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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140
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Interventions
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Intervention:
A home-based exercise programme, supervised by a physiotherapist. Appropriate exercises will be chosen from a menu of:
1. Balance training exercises in sitting and standing
2. Stretches
3. A programme of walking and moderate intensity strengthening exercises for hip, knee and ankle
4. Control:
Usual care.
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Primary outcome measure(s)
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Rates of falling at 8 weeks and 6 months.
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Secondary outcome measure(s)
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1. Repeat fallen, nearly fallen or experienced injurious falls
2. Functional Reach
3. The Berg Balance Test
4. PD Self-assessment Scale
5. The Euro Quality of Life scale
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Sources of funding
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Action Medical Research (UK)
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Trial website
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Publications
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2007 results in http://www.ncbi.nlm.nih.gov/pubmed/17119004
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Contact name
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Prof
Ann
Ashburn
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Address
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Health & Rehabilitation Research Unit,
Level E, Centre Block, Mail Point 886,
Southampton General Hospital,
Tremona Road
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City/town
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Southampton
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Zip/Postcode
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SO16 6YD
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Country
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United Kingdom
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Tel
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+44 (0)2380 796 469
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Email
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a.m.ashburn@soton.ac.uk
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Sponsor
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Action Medical Research (UK)
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Address
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Vincent House
Horsham
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City/town
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West Sussex
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Zip/Postcode
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RH12 2DP
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Country
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United Kingdom
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Sponsor website:
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http://www.action.org.uk/
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Date applied
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08/12/2003
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Last edited
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21/01/2009
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Date ISRCTN assigned
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05/01/2004
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