Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000494235
Ethics application status
Approved
Date submitted
25/05/2009
Date registered
22/06/2009
Date last updated
22/06/2009
Type of registration
Retrospectively registered

Titles & IDs
Public title
A randomised controlled study of the efficacy of a workstations group training program compared to a "one on one" program in improving the balance and mobility of a post acute inpatient group
Scientific title
A randomised controlled study of the efficacy of a workstations group training program compared to a "one on one" program in improving the balance and mobility of a post acute inpatient group
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Fraility in post acute inpatients requiring physiotherapy 4850 0
Condition category
Condition code
Physical Medicine / Rehabilitation 237197 237197 0 0
Physiotherapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Functional training and exercise rehabilitation program administered in physiotherapy workstations group sessions. Each group workstation session will consist of up to 6 individualised workstations which each patient completes for a period of 6-10 minutes before moving to the next activity. The maximum staff to patient ratio of 1:5.
Subjects attend 1hr / day, 5 days a week until time of discharge from unit
Intervention code [1] 236632 0
Rehabilitation
Comparator / control treatment
1 hour a day of physiotherapy provided on a one to one basis 5 days a week until time of discharge from the unit.
Control group
Active

Outcomes
Primary outcome [1] 238009 0
Functional mobility status as measured by the Clinical Outcomes Variable scale (COVS)
Timepoint [1] 238009 0
At admission to study, at discharge from unit and at 4 weeks post discharge
Secondary outcome [1] 242148 0
Standing balance as measured by the Functional reach test
Timepoint [1] 242148 0
At admission to study, at discharge from unit and at 4 weeks post discharge
Secondary outcome [2] 242149 0
Standing balance as measured by the Step test
Timepoint [2] 242149 0
At admission to study, at discharge from unit and at 4 weeks post discharge
Secondary outcome [3] 242150 0
Mobility status as measured by the Timed Up and Go test
Timepoint [3] 242150 0
At admission to study, at discharge from unit and at 4 weeks post discharge
Secondary outcome [4] 242151 0
Mobility status as measured by the 6 minute walk test
Timepoint [4] 242151 0
At admission to study, at discharge from unit and at 4 weeks post discharge
Secondary outcome [5] 242152 0
Quality of Life as measured by the EQ-5D health questionnaire
Timepoint [5] 242152 0
At admission to study, at discharge from unit and at 4 weeks post discharge
Secondary outcome [6] 242153 0
Patient satisfaction as measured by questionnaire adapted from Pound et al.
Timepoint [6] 242153 0
at discharge from unit and at 4 weeks post discharge

Eligibility
Key inclusion criteria
Admitted to the Extended Care Unit 1 of The Prince Charles Hospital, Brisbane, Australia
Assessed as requiring Physiotherapy intervention
Able to sit unsupported
Able to transfer independently and safely or with only 1 person assistance
able to follow 2 stage instructions
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Require 2 person assistance with transfers
Require mechanical assistance (e.g.Hoist) with transfers
Unable to stand unsupported for > 10 seconds
Unable to follow 2 stage instructions
Have disruptive or behaviourial problems that preclude inclusion in a group
Have an inffective condition that precludes inclusion in a group
Have unmanaged incontinence (bladder or bowel)

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)
Following admission to the unit where the study is undertaken, the patient's medical record is screened to determine appropriateness. Patient's are assessed by the study nurse as to whether they meet the inclusion criteria and none of the exclusioncriteria. If so they are invited to participate in the study. If patient consents to inclusion they are then randomised by person not involved in study
A large opaque envelop contains 100 slips of paper: 50 marked "circuit", 50 marked "usual". As each subject is enrolled a slip of paper is drawn out to determine allocation. The slip of paper is not replaced in the envelop.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
simple randomisation - consecutive subjects were randomised using a simple sequence.
A large opaque envelop contains 100 slips of paper: 50 marked "circuit", 50 marked "usual". As each subject is enrolled a slip of paper is drawn out. The slip of paper is not replaced in the envelop.
Stratified allocation was not employed
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/07/2006
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 5012 0
Charities/Societies/Foundations
Name [1] 5012 0
The Prince Charles Hospital Foundation
Country [1] 5012 0
Australia
Funding source category [2] 5013 0
Charities/Societies/Foundations
Name [2] 5013 0
Australian Physiotherapy Association
Country [2] 5013 0
Australia
Funding source category [3] 5014 0
Government body
Name [3] 5014 0
Allied Health Workforce Advice and Coordination Unit
Country [3] 5014 0
Australia
Primary sponsor type
Individual
Name
Mr Paul Bew
Address
Internal Medicine Services
4th Floor Administration Building
The Prince Charles Hospital
Rode Rd Chermside
Queensland
4032
Country
Australia
Secondary sponsor category [1] 4532 0
None
Name [1] 4532 0
Address [1] 4532 0
Country [1] 4532 0
Other collaborator category [1] 679 0
Individual
Name [1] 679 0
Associate Professor Nancy Low Choy
Address [1] 679 0
Physiotherapy Program Coordinator
Faculty of Health Sciences and Medicine
Bond University
Gold Coast
Queensland
4229
Country [1] 679 0
Australia
Other collaborator category [2] 680 0
Individual
Name [2] 680 0
Dr Jennifer Nitz
Address [2] 680 0
Physiotherapy Department
School of Health and Rehabilitation Sciences
Univeristy of Queensland
St Lucia,
Queensland
4067
Country [2] 680 0
Australia
Other collaborator category [3] 681 0
Individual
Name [3] 681 0
Dr Terrence Haines
Address [3] 681 0
Allied Health Research Unit
Kingston Centre, Cnr Warrigal and Kingston Rds, Cheltemham
Victoria
3192
Country [3] 681 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 7111 0
Human Research Ethics Committee
Ethics committee address [1] 7111 0
Ethics committee country [1] 7111 0
Australia
Date submitted for ethics approval [1] 7111 0
Approval date [1] 7111 0
26/04/2006
Ethics approval number [1] 7111 0
EC2424
Ethics committee name [2] 7112 0
Medical research Ethics Committee
Ethics committee address [2] 7112 0
Ethics committee country [2] 7112 0
Australia
Date submitted for ethics approval [2] 7112 0
Approval date [2] 7112 0
16/05/2007
Ethics approval number [2] 7112 0
2007000644

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

Contacts
Principal investigator
Name 29643 0
Address 29643 0
Country 29643 0
Phone 29643 0
Fax 29643 0
Email 29643 0
Contact person for public queries
Name 12890 0
Mr Paul Bew
Address 12890 0
Internal Medicine Services
The Prince Charles Hospital
Rode Rd, Chermside,
Queensland,
4032
Country 12890 0
Australia
Phone 12890 0
+61 7 3139 5897
Fax 12890 0
+61 7 3139 4923
Email 12890 0
[email protected]
Contact person for scientific queries
Name 3818 0
Mr Paul Bew
Address 3818 0
Internal Medicine Services
The Prince Charles Hospital
Rode Rd, Chermside,
Queensland
4032
Country 3818 0
Australia
Phone 3818 0
+61 7 3139 5897
Fax 3818 0
+61 7 3139 4923
Email 3818 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
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