Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000242224
Ethics application status
Approved
Date submitted
20/02/2009
Date registered
11/05/2009
Date last updated
5/07/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
Does the addition of Functional Incidental Training to standard Physiotherapy treatment affect function, depression and quality of life for bed based Transition Care Program clients in regional Victoria
Scientific title
Does the addition of Functional Incidental Training to standard Physiotherapy treatment affect destination, function, depression and quality of life for bed based Transition Care Program clients in regional Victoria
Secondary ID [1] 280149 0
New secondary ID. Please modify.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Medically stable, over 65 year olds who accept a bed based Transition Care Program place 4365 0
Older people who have completed an acute or subacute episode in hospital and are assessed as being able to benefit from short term additional therapy and support to maximise their functional return and prevent premature admission to residential care. 4637 0
Condition category
Condition code
Physical Medicine / Rehabilitation 4610 4610 0 0
Physiotherapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Functional Incidental Training (FIT) which is defined as ‘Care processes that are designed to increase activity and functional ability with emphasis placed on the repetition of exercises that are specific to the functional skills involved with toileting and other activities of daily living’. For this study FIT will be instituted to be undertaken four times daily from Monday to Friday and on weekends if possible. The FIT exercise component will be designed to fit the individual abilities of the participant. For the standard physiotherapy plus FIT group this will mean weekly physiotherapy treatments, an additional visit from a physiotherapy assistant, encouragement to exercise from the Activity workers and residence staff and a written list of individualised exercises on the wall in their room. The intervention will take place while the participant is occupying a Transition Care Program bed which averages approximately six weeks but may be up to 18 weeks.
Intervention code [1] 4097 0
Rehabilitation
Comparator / control treatment
Standard physiotherapy will be tailored to the person but may include a standing balance exercise class weekly, a chair based exercise class weekly, endurance walking, a chair based or standing exercise program, hydrotherapy or a gym program. Standard physiotherapy takes place while the participant is occupying a Transition Care Program bed which averages approximately six weeks but may be up to 18 weeks.
Control group
Active

Outcomes
Primary outcome [1] 5483 0
Destination following discharge from Transiton Care Program. Each person will be reassessed at discharge, three and six months at which time their residence will be noted on the assessment sheet.
Timepoint [1] 5483 0
Participants were assessed at admission to the Transition Care Program, at discharge, three and six months.
Secondary outcome [1] 9238 0
Function as measured by the deMorton Mobility Index (DEMMI), Five times sit to stand and Berg Balance Scale
Timepoint [1] 9238 0
Measured at admission, discharge, three and six months
Secondary outcome [2] 9239 0
Depression as measured on the Geriatric Depression Scale
Timepoint [2] 9239 0
Measured at admission, discharge, three and six months.
Secondary outcome [3] 9240 0
Quality of life as measured by the EuroQol (EQ5D)
Timepoint [3] 9240 0
Measured at admission, discharge, three months and six months.

Eligibility
Key inclusion criteria
Accepted into a bed based Transition Care Program place (this means that the person has completed their episode of care, are medically stable, would be assessed by the Aged Care Assessment Team for at least a low level of permanent residential care and able to benefit from additional services and a period to assess their long term opportunities)
Resident in the Bendigo area
Consent to be part of the study
Minimum age
65 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Not on Transition Care Program
On Transition Care Program but in a community place
Not resident in Bendigo
Does not consent

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
The Transition Care Program assessor will give the potential participant information regarding the project. If they agree to talk to the researcher a referral will be made. The researcher will then contact the potential participant and explain the project. If they agree to take part a consent form will then be signed. The demographic and outcome measures will then take place prior to randomisation. Allocation will be concealed as central randomisation will take place by computer.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The excel randomisation feature will be used to randomise to the standard physiotherapy or standard physiotherapy plus FIT groups.
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/04/2009
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
50
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 1521 0
3552

Funding & Sponsors
Funding source category [1] 4545 0
Self funded/Unfunded
Name [1] 4545 0
Carol Parker
Country [1] 4545 0
Australia
Primary sponsor type
University
Name
La Trobe University
Address
Edwards Road
Bendigo VIC 3552
Country
Australia
Secondary sponsor category [1] 4101 0
None
Name [1] 4101 0
Address [1] 4101 0
Country [1] 4101 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 6870 0
Bendigo Health Human Research Ethics Committee
Ethics committee address [1] 6870 0
Ethics committee country [1] 6870 0
Australia
Date submitted for ethics approval [1] 6870 0
Approval date [1] 6870 0
02/04/2009
Ethics approval number [1] 6870 0
002/2009

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

Contacts
Principal investigator
Name 29312 0
Address 29312 0
Country 29312 0
Phone 29312 0
Fax 29312 0
Email 29312 0
Contact person for public queries
Name 12559 0
Carol Parker
Address 12559 0
Collaborative Health, Education and Research Centre
Bendigo Health
PO Box 126
Bendigo VIC 3552
Country 12559 0
Australia
Phone 12559 0
+61 3 5454 6413
Fax 12559 0
Email 12559 0
[email protected]
Contact person for scientific queries
Name 3487 0
Helen McBurney
Address 3487 0
School of Physiotherapy
Level 5, East Wing
Anne Caudle Centre
PO Box 126
Bendigo VIC 3552
Country 3487 0
Australia
Phone 3487 0
+61 3 5454 7021
Fax 3487 0
Email 3487 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.