Condition category
Nervous System Diseases
Date applied
08/12/2003
Date assigned
05/01/2004
Last edited
21/01/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

http://www.action.org.uk/

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

  1. 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.

Additional files

Editorial Notes