Submission date
08/03/2007
Registration date
31/05/2007
Last edited
21/12/2011
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Nervous System Diseases
Retrospectively registered
? Protocol not yet added
? SAP not yet added
Results added
? Raw data not yet added
Study completed

Plain English Summary

Not provided at time of registration

Study website

Contact information

Type

Scientific

Contact name

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/CTIS number

IRAS 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(s)

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

Study setting(s)

Not specified

Study 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

Primary outcome measure

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 study start date

12/03/2007

Overall study end date

30/04/2009

Reason abandoned (if study stopped)

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(s)

Patient

Age group

Not Specified

Sex

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

England, United Kingdom

Study 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
England
United Kingdom

Sponsor type

University/education

Website

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

ROR

https://ror.org/04dtfyh05

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

Individual participant data (IPD) sharing plan

IPD sharing plan summary

Not provided at time of registration

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 01/11/2011 Yes No

Additional files

Editorial Notes