Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12608000427370
Ethics application status
Approved
Date submitted
11/06/2008
Date registered
26/08/2008
Date last updated
17/03/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
Mobility in older adults receiving hospital based rehabilitation: A pilot study
Scientific title
Reducing length of stay and improving mobility by increasing physical activity in older adults receiving hospital based rehabilitation: A pilot study.
Secondary ID [1] 252320 0
none
Universal Trial Number (UTN)
Trial acronym
ROAM
Linked study record

Health condition
Health condition(s) or problem(s) studied:
sub-acute care 3096 0
Condition category
Condition code
Physical Medicine / Rehabilitation 3255 3255 0 0
Physiotherapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Subjects in the intervention group will receive 'enhanced physical activity'. This will involve daily individual sessions provided by a physiotherapist or physiotherapy assistant. Subjects will perform exercises that are appropriate to their functional level, with an emphasis on mobility tasks. The duration of the session will vary, depending on the patient's tolerance, but will range from 5 to 60 minutes. These sessions will be in addition to any other therapy subjects are already receiving, and will be provided from enrolment until discharge from sub-acute care.
Intervention code [1] 2837 0
Rehabilitation
Comparator / control treatment
usual care, which may include physiotherapy, occupational therapy, speech pathology, nursing, medical care and other allied health services as required.
Control group
Active

Outcomes
Primary outcome [1] 4140 0
Elderly Mobility Scale
Timepoint [1] 4140 0
admission and discharge from sub acute care
Primary outcome [2] 4141 0
Length of stay
Timepoint [2] 4141 0
discharge from sub acute care
Secondary outcome [1] 6980 0
Timed up and go
Timepoint [1] 6980 0
admission and discharge from sub acute care
Secondary outcome [2] 6981 0
Barthel index, which is a global measure of functional independence
Timepoint [2] 6981 0
admission and discharge from sub acute care, 3 months post discharge
Secondary outcome [3] 6982 0
Australian Quality of Life (AQol), which measures quality of life
Timepoint [3] 6982 0
Admission, Discharge and 3 months post discharge
Secondary outcome [4] 6983 0
discharge destination
Timepoint [4] 6983 0
discharge
Secondary outcome [5] 6984 0
de Morton Mobility Index (DEMMI), which measures mobility.
Timepoint [5] 6984 0
admission and discharge

Eligibility
Key inclusion criteria
older adults admitted to a specialist aged care facility, with 'improve gait/ or mobility' as a goal of admission
Minimum age
60 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
enrolled in other intervention trials.
Primary reason for admission is to await residential care
Identified on admission as not requiring physiotherapy.
There are medical restrictions preventing mobilisation.

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)
computer generated allocation schedule held by a third party.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Blocked, stratified randomisation. Participants will be stratified based on functional level into one of two groups; either 'nonambulant' (unable to walk, or requires assistance of 2 people) or 'ambulant' (requires assistance of one person or independent with walking). Computer generated allocation will be used to randomly assign participants.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
20/08/2008
Actual
4/09/2008
Date of last participant enrolment
Anticipated
Actual
27/11/2008
Date of last data collection
Anticipated
Actual
Sample size
Target
40
Accrual to date
Final
47
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 3345 0
Hospital
Name [1] 3345 0
Austin Health Medical Research Foundation
Country [1] 3345 0
Australia
Funding source category [2] 3644 0
Other
Name [2] 3644 0
Gait Centre for Clincial Research Excellence
Country [2] 3644 0
Australia
Primary sponsor type
Individual
Name
Dr Catherine Said
Address
Physiotherapy Department
Austin Health
300 Waterdale Rd
Heidelberg West, 3081
VIC
Country
Australia
Secondary sponsor category [1] 2990 0
None
Name [1] 2990 0
Address [1] 2990 0
Country [1] 2990 0
Other collaborator category [1] 275 0
Individual
Name [1] 275 0
Dr Michael Woodward
Address [1] 275 0
Aged Care
Austin Health
300 Waterdale Rd
Heidelberg West, 3081
VIC
Country [1] 275 0
Australia
Other collaborator category [2] 276 0
Individual
Name [2] 276 0
Professor Meg Morris
Address [2] 276 0
School of Physiotherapy

University of Melbourne
1st Floor
200 Berkeley Street
Carlton 3010
VIC
Country [2] 276 0
Australia
Other collaborator category [3] 306 0
Individual
Name [3] 306 0
Associate Professor Julie Bernhardt
Address [3] 306 0
National Stroke Research Institite
300 Waterdale Rd
Heidelberg West, 3081
VIC
Country [3] 306 0
Australia
Other collaborator category [4] 307 0
Individual
Name [4] 307 0
Dr Toby Cumming
Address [4] 307 0
National Stroke Research Institite
300 Waterdale Rd
Heidelberg West, 3081
VIC
Country [4] 307 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 5370 0
Austin Health Non Drug Study Review Committee
Ethics committee address [1] 5370 0
Ethics committee country [1] 5370 0
Australia
Date submitted for ethics approval [1] 5370 0
08/04/2008
Approval date [1] 5370 0
23/06/2008
Ethics approval number [1] 5370 0
03223

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

Contacts
Principal investigator
Name 28558 0
Dr Catherine Said
Address 28558 0
Austin Health
Studley Rd
Heidelberg, 3081
Country 28558 0
Australia
Phone 28558 0
61 3 94963697
Fax 28558 0
Email 28558 0
[email protected]
Contact person for public queries
Name 11715 0
Dr Catherine Said
Address 11715 0
Physiotherapy Department
Austin Health
300 Waterdale Rd
Heidelberg West 3081
VIC
Country 11715 0
Australia
Phone 11715 0
03 9496 2892
Fax 11715 0
Email 11715 0
[email protected]
Contact person for scientific queries
Name 2643 0
Dr Catherine Said
Address 2643 0
Physiotherapy Department
Austin Health
300 Waterdale Rd
Heidelberg West 3081
VIC
Country 2643 0
Australia
Phone 2643 0
03 9496 2892
Fax 2643 0
Email 2643 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.