Contact information
Type
Scientific
Primary contact
Prof Ann Ashburn
ORCID ID
Contact details
Health & Rehabilitation Research Unit
Level E
Centre Block
Mail Point 886
Southampton General Hospital
Tremona Road
Southampton
SO16 6YD
United Kingdom
+44 (0)2380 796 469
a.m.ashburn@soton.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
AP0888
Study information
Scientific title
Acronym
Study hypothesis
To evaluate the effectiveness of a personalised home programme of exercises and strategies for repeat fallers with Parkinson's disease (PD).
Ethics approval
East Dorset Local Research Ethics Committee gave approval in March 2001 (ref: 13/00/S)
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Other
Trial type
Treatment
Patient information sheet
Condition
Parkinson's disease
Intervention
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.
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measures
Rates of falling at 8 weeks and 6 months.
Secondary outcome measures
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
Overall trial start date
01/01/2004
Overall trial end date
01/01/2007
Reason abandoned
Eligibility
Participant inclusion criteria
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
Participant type
Patient
Age group
Other
Gender
Both
Target number of participants
140
Participant exclusion criteria
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
Recruitment start date
01/01/2004
Recruitment end date
01/01/2007
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Health & Rehabilitation Research Unit,
Southampton
SO16 6YD
United Kingdom
Sponsor information
Organisation
Action Medical Research (UK)
Sponsor details
Vincent House
Horsham
West Sussex
RH12 2DP
United Kingdom
Sponsor type
Charity
Website
Funders
Funder type
Charity
Funder name
Action Medical Research (UK)
Alternative name(s)
AMR
Funding Body Type
private sector organisation
Funding Body Subtype
other non-profit
Location
United Kingdom
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
2007 results in http://www.ncbi.nlm.nih.gov/pubmed/17119004
Publication citations
-
Results
Ashburn A, Fazakarley L, Ballinger C, Pickering R, McLellan LD, Fitton C, A randomised controlled trial of a home based exercise programme to reduce the risk of falling among people with Parkinson's disease., J. Neurol. Neurosurg. Psychiatr., 2007, 78, 7, 678-684, doi: 10.1136/jnnp.2006.099333.