Condition category
Nervous System Diseases
Date applied
08/03/2007
Date assigned
31/05/2007
Last edited
21/12/2011
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

Mrs Victoria Goodwin

ORCID ID

Contact details

Primary Care Research Group
Peninsula Medical School
Smeall Building
St Luke's Campus
Exeter
EX1 2LU
United Kingdom
+44 (0)1392 262745
victoria.goodwin@pms.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

RDA/02/06/041

Study information

Scientific title

Acronym

Acronym added as of 28/06/2007: GET uP

Study hypothesis

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?

Ethics approval

Devon and Torbay Research Ethics Committee, approved on 5 February 2007. Ref: 07/Q2102/8

Study design

Randomised, single-blind, controlled trial.

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

Parkinson's disease

Intervention

A group based strength and balance exercise progamme, led by a physiotherapist plus additional home exercises versus usual care for 10 weeks.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Falls at 10 and 30 weeks post baseline/recruitment.

Secondary outcome measures

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)

Overall trial start date

12/03/2007

Overall trial end date

30/04/2009

Reason abandoned

Eligibility

Participant inclusion criteria

People diagnosed with Parkinson's disease who report two or more falls in the past year and who are independently mobile.

Participant type

Patient

Age group

Not Specified

Gender

Both

Target number of participants

248

Participant exclusion criteria

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

Recruitment start date

12/03/2007

Recruitment end date

30/04/2009

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Primary Care Research Group
Exeter
EX1 2LU
United Kingdom

Sponsor information

Organisation

Peninsula Medical School (UK)

Sponsor details

c/o Professor John Campbell
Primary Care Research Group
Smeall Building
St Luke's Campus
Exeter
EX1 2LU
United Kingdom

Sponsor type

University/education

Website

http://www.pms.ac.uk/pms/

Funders

Funder type

Government

Funder name

Personal Award Scheme Researcher Development Award from National Institute of Health Research (UK) Ref: RDA/02/06/041

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

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

1. 2011 results in http://www.ncbi.nlm.nih.gov/pubmed/21856692

Publication citations

  1. Results

    Goodwin VA, Richards SH, Henley W, Ewings P, Taylor AH, Campbell JL, An exercise intervention to prevent falls in people with Parkinson's disease: a pragmatic randomised controlled trial., J. Neurol. Neurosurg. Psychiatr., 2011, 82, 11, 1232-1238, doi: 10.1136/jnnp-2011-300919.

Additional files

Editorial Notes