Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12608000352303
Ethics application status
Approved
Date submitted
17/06/2008
Date registered
24/07/2008
Date last updated
24/08/2009
Type of registration
Prospectively registered

Titles & IDs
Public title
Reliability of the "timed up and go" (TUG) test conducted in the home environment in the frail aged
Scientific title
Reliability of the "timed up and go" (TUG) test conducted in the home environment in the frail aged
Secondary ID [1] 597 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
The Timed Up and Go (TUG) test is a clinically recognised test for quantifying functional mobility. It is quick, easy to perform and reliable in a clinic setting. Rehabilitation in the Home (RITH) physiotherapists utilise the TUG test to assess and reassess clients in their home environment. However, there is no data on the reliability of TUG in the home environment. In addition, due to the nature of home based therapy, it is often difficult to utilise the recommended seat height for the test. This study aims to investigate the reliability of the TUG in the home environment, compared to the outpatient setting and to determine the reliability of the TUG when a non-standard chair is utilised for the testing. 3272 0
Functional mobility in frail aged 3331 0
Condition category
Condition code
Physical Medicine / Rehabilitation 3486 3486 0 0
Physiotherapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The TUG test is to be investigated for reliability for use in the home environment within the frail aged population. The intervention part will be the performance of the TUG in the participant's home environment. This will occur within 24 hours of the control testing (see below). The testing procedure involves a standard chair (height 44-47cm with arms) positioned with a marker placed 3 meters away on the floor. The patient is tested wearing their usual footwear and walking aid and no physical assistance is given. The patient starts sitting in the chair and is instructed to stand up and walk to the mark, turn around and walk back to sit in the chair. On “Go” the patient is timed to complete the task. At each setting, a practice test will occur prior to the actual test. A rest will occur between the practice and actual tests of approximately 3 minutes. Following the second test, a third TUG will be conducted using a non-standard chair. The total testing time including rests will be 10 minutes. The testing will occur once only, on the day following the control treatment. All subjects will act as their own controls and be tested in both the clinical setting and the home setting.
Intervention code [1] 3010 0
Rehabilitation
Comparator / control treatment
The control group will be the TUG test performed in the clinical outpatient setting prior to the test be performed in the clients home. The testing procedure involves a standard chair (height 44-47cm with arms) positioned with a marker placed 3 meters away on the floor. The patient is tested wearing their usual footwear and walking aid and no physical assistance is given. The patient starts sitting in the chair and is instructed to stand up and walk to the mark, turn around and walk back to sit in the chair. On “Go” the patient is timed to complete the task. A practice test will occur prior to the actual test. A rest will occur between the practice and actual tests of approximately 3 minutes. The total testing time including rests will be 10 minutes. The TUG will be undertaken on one day only.
Control group
Active

Outcomes
Primary outcome [1] 4329 0
Correlation of TUG score between outpatient setting and home setting using a standardised chair
Timepoint [1] 4329 0
Within 48 hours of clinic assessment
Secondary outcome [1] 7411 0
Correlation of TUG score between outpatient setting and home setting using a non-standardised chair
Timepoint [1] 7411 0
Within 48 hours of clinic assessment

Eligibility
Key inclusion criteria
Patients attending Moss st clinic for rehabilitation.
Residing in Fremantle Hospital catchment area.
Clients must be able to perform the TUG test in the clinical setting without assistance from the therapist.
Client will be screened for home visiting risks as per the South Metropolitan Area Health Service Rehabilitation in the Home policies and procedures.
signed consent to allow the therapist to visit their home
Minimum age
65 Years
Maximum age
100 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Clients requiring assistance to mobilise from a therapist.
Clients residing in high or low level residential car facilities.
Clients with a known Mini-Mental State Exam of less than 24
Clients who are screened as a home visiting risk as per South Metropolitan Area Health Service (SMAHS) Rehabilitation in the Home (RITH) policies and procedures.

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
4/08/2008
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 921 0
6160
Recruitment postcode(s) [2] 922 0
6158
Recruitment postcode(s) [3] 923 0
6157
Recruitment postcode(s) [4] 924 0
6156
Recruitment postcode(s) [5] 925 0
6162
Recruitment postcode(s) [6] 926 0
6163
Recruitment postcode(s) [7] 927 0
6164
Recruitment postcode(s) [8] 928 0
6150
Recruitment postcode(s) [9] 929 0
6153
Recruitment postcode(s) [10] 930 0
6154

Funding & Sponsors
Funding source category [1] 3490 0
Hospital
Name [1] 3490 0
Fremantle hospital and Health Service (FHHS)
Country [1] 3490 0
Australia
Primary sponsor type
Hospital
Name
Fremantle Hospital and Health Service (FHHS)
Address
PO Box 480
Fremantle
WA
6160
Country
Australia
Secondary sponsor category [1] 3133 0
None
Name [1] 3133 0
Address [1] 3133 0
Country [1] 3133 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 5521 0
Human Research Ethics Committee
South Metropolitan Area Health Service
Ethics committee address [1] 5521 0
Ethics committee country [1] 5521 0
Australia
Date submitted for ethics approval [1] 5521 0
15/07/2008
Approval date [1] 5521 0
23/07/2008
Ethics approval number [1] 5521 0
08/262

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 28673 0
Address 28673 0
Country 28673 0
Phone 28673 0
Fax 28673 0
Email 28673 0
Contact person for public queries
Name 11830 0
Sarah Morriss
Address 11830 0
c/o RITH FHHS
Fremantle hospital
PO Box 480
Fremantle WA 6959
Country 11830 0
Australia
Phone 11830 0
08 9431 3898
Fax 11830 0
Email 11830 0
[email protected]
Contact person for scientific queries
Name 2758 0
Sarah Morriss
Address 2758 0
c/o RITH FHHS
Fremantle Hospital
PO Box 480
Fremantle WA 6959
Country 2758 0
Australia
Phone 2758 0
08 9431 3898
Fax 2758 0
Email 2758 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.