Randomised controlled trial of a home-based exercise programme to reduce fall frequency among people with Parkinson's disease (PD)

ISRCTN	ISRCTN63503875
DOI	https://doi.org/10.1186/ISRCTN63503875
Secondary identifying numbers	AP0888

Submission date: 08/12/2003
Registration date: 05/01/2004
Last edited: 21/01/2009

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Nervous System Diseases

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Ann Ashburn
Scientific

Health & Rehabilitation Research Unit
Level E, Centre Block, Mail Point 886
Southampton General Hospital
Tremona Road
Southampton
SO16 6YD
United Kingdom

Phone	+44 (0)2380 796 469
Email	a.m.ashburn@soton.ac.uk

Study information

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Other
Study type	Treatment
Scientific title
Study objectives	To evaluate the effectiveness of a personalised home programme of exercises and strategies for repeat fallers with Parkinson's disease (PD).
Ethics approval(s)	East Dorset Local Research Ethics Committee gave approval in March 2001 (ref: 13/00/S)
Health condition(s) or problem(s) studied	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
Primary outcome measure	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 study start date	01/01/2004
Completion date	01/01/2007

Eligibility

Participant type(s)	Patient
Age group	Other
Sex	Both
Target number of participants	140
Key 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
Key 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
Date of first enrolment	01/01/2004
Date of final enrolment	01/01/2007

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

Health & Rehabilitation Research Unit,

Southampton
SO16 6YD
United Kingdom

Sponsor information

Action Medical Research (UK)
Charity

Vincent House
Horsham
West Sussex
RH12 2DP
United Kingdom

Website	http://www.action.org.uk/
"ROR"	https://ror.org/01wcqa315

Funders

Funder type

Charity

Action Medical Research (UK)
Private sector organisation / Trusts, charities, foundations (both public and private)

Alternative name(s): actionmedres, action medical research for children, AMR
Location: United Kingdom

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/07/2007		Yes	No