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Trial registered on ANZCTR
Registration number
ACTRN12611000788976
Ethics application status
Approved
Date submitted
27/07/2011
Date registered
27/07/2011
Date last updated
24/02/2014
Type of registration
Prospectively registered
Titles & IDs
Public title
Physical Activity for Older Home Care Clients Receiving a Restorative Care Program
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Scientific title
A randomised controlled trial to test the effectiveness of two physical activity programs for older people receiving a restorative care program
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Secondary ID [1]
252398
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Nil known
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Universal Trial Number (UTN)
U1111-1116-4526
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Functional-mobility for older home care clients
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Condition category
Condition code
Physical Medicine / Rehabilitation
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Other physical medicine / rehabilitation
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
LiFE is the Lifestyle and Functional Exercise Program. The LiFE physical activity program integrates physical activity into daily tasks and routines. LiFE will be delivered by the Care Managers as part of the restorative care service in the clients home (visits are generally every 10 days to two weeks, for a total period of 8 weeks). All Care Managers are allied health specialists (OT, physio, RN) and have been trained to deliver the LiFE program. Clients will receive a manual outlining the activities (eg one leg stand for balance, sit to stand out of a chair for strength) and the Care Managers will give a number of these activities to the clients at each visit (dependent on the illness/injury stage for the client, the expertise of the Care Manager will be required to determine this). Clients will be asked to incorporate these activities into their daily routines, for example to pick something up off the floor by bending their knees and squatting rather than bending at the waist, reach up for a cup to maintain calf and ankle strength rather than placing it within easy access. The LiFE philosophy is to embed these activities into daily living and therefore not require the client to complete a set number of reps, sets or volume per week, unlike most activity programs. It is this variation that is being tested in comparison to the "current" exercise program which outlines set, reps and times per week of a number of exercises provided to the client on a doublesided piece of paper. The restorative care service is delivered for a period of 8 weeks meaning most clients will receive four sessions with their Care Manager. Each session with the Care Manager runs between 1-2 hours, dependent on the progress of the client and how much explanation is required across all components of the restorative care program (not only the physical activity component).
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Intervention code [1]
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Prevention
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Intervention code [2]
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Rehabilitation
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Intervention code [3]
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Lifestyle
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Comparator / control treatment
The "current" physical activity program prescribed to the restorative care clients is a series of exercises (Level 1 and Level 2) provided to the client on a double sided piece of paper with number of reps, sets and times per week documented next to each diagram of the exercise. The Care Managers have delivered this activity program for a number of years and generally the reps are 5 reps, 3 sets, 3 times per week. The same number of visits described above will occur as the physical activity component of the restorative care service is one of many components and it is expected that Care Managers see their clients every 10 days to 2 weeks to monitor their progress and increase elements of the components as the client improves from their injury or illness in returning to independent living. No weights or additional equipment is required for either physical activity program.
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Control group
Active
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Outcomes
Primary outcome [1]
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Functional mobility using a composite variable made up Timed up and go, chair sit to stand, functional reach and tandem walk and calculated using weightings
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Assessment method [1]
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Timepoint [1]
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at baseline, 8 weeks and 6 months after intervention commencement
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Secondary outcome [1]
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Balance using the tandem walk and functional reach tests
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Assessment method [1]
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Timepoint [1]
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at baseline, 8 weeks and 6 months after intervention commencement
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Secondary outcome [2]
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Sit to stand test to determine lower body strength
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Assessment method [2]
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Timepoint [2]
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at baseline, 8 weeks and 6 months after intervention commencement
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Secondary outcome [3]
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Falls efficacy scale to test balance confidence
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Assessment method [3]
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Timepoint [3]
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at baseline, 8 weeks and 6 months after intervention commencement
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Secondary outcome [4]
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Activities balance confidence scale to determine balance confidence for more challenging activities
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Assessment method [4]
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Timepoint [4]
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at baseline, 8 weeks and 6 months after intervention commencement
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Secondary outcome [5]
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Vitality plus scale to test psychological well-being
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Assessment method [5]
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Timepoint [5]
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at baseline, 8 weeks and 6 months after intervention commencement
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Secondary outcome [6]
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Late life function and disability scale to test function and disability levels of participants
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Assessment method [6]
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Timepoint [6]
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at baseline, 8 weeks and 6 months after intervention commencement
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Secondary outcome [7]
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Timed up and Go to tests mobility
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Assessment method [7]
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Timepoint [7]
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at baseline, 8 weeks and 6 months after intervention
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Eligibility
Key inclusion criteria
Individuals receiving one of Silver Chain’s restorative programs (HIP or PEP), living independently, aged 65 and over, are English speaking and do not have a diagnosis of dementia or other neuro-degenerative disease.
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Minimum age
65
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
Does not speak English, diagnosis of late-stage dementia, 64 years and under, and not living independently, not in a Silver Chain restorative program (HIP or PEP), not deemed appropriate for a physical activity program.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
A Restorative Care Manager conducts an assessment on a client, if they are assessed as needing a physical activity program as part of their restorative care service they will be contacted by a Research Assistant, the project explained to them, on approval sign consent forms, and then randomise the participant to the current or LiFE physical activity programs by opening a sealed opaque envelope with the intervention type enclosed.
Allocation is concealed by a sealed opaque envelope
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation by using a randomisation table created by computer software
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
Efficacy
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Date of first participant enrolment
Anticipated
10/08/2011
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Actual
19/08/2011
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Date of last participant enrolment
Anticipated
17/05/2012
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Actual
17/05/2012
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Date of last data collection
Anticipated
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Actual
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Sample size
Target
150
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
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Funding & Sponsors
Funding source category [1]
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Government body
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Name [1]
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Healthway
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Address [1]
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Healthway
Ground Floor
24 Outram Street
West Perth WA 6005
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Country [1]
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Australia
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Primary sponsor type
Individual
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Name
Elissa Burton
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Address
Centre for Research on Ageing
Curtin University
GPO Box U1987
Perth WA Australia 6845
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Country
Australia
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Secondary sponsor category [1]
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Individual
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Name [1]
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Professor Gill Lewin
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Address [1]
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Centre for Research on Ageing
Curtin University
GPO Box U1987
Perth WA Australia 6845
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Country [1]
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Australia
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
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Silver Chain Human Research Ethics Committee
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Ethics committee address [1]
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6 Sundercombe Street Osborne Park WA 6017
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Ethics committee country [1]
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Australia
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Date submitted for ethics approval [1]
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Approval date [1]
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26/10/2010
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Ethics approval number [1]
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EC App 065
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Ethics committee name [2]
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Curtin University Human Research Ethics Committee
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Ethics committee address [2]
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GPO Box U1987 Perth WA 6845
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Ethics committee country [2]
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Australia
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Date submitted for ethics approval [2]
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Approval date [2]
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16/11/2010
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Ethics approval number [2]
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HR 145/2010
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Summary
Brief summary
To compare the effectiveness of different physical activity strategies in increasing home care clients’ levels of physical activity in the short and long term; and explore their contribution to the achievement of functional independence.
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Trial website
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Trial related presentations / publications
Burton, E., Lewin, G., Clemson, L., & Boldy, D. 2014. Long term benefits of a lifestyle exercise program for older people receiving a restorative home care service: A pragmatic randomized controlled trial. Healthy Aging & Clinical Care in the Elderly: 6 1–9 doi:10.4137/HACCE.S13445. Burton, E., Lewin, G., Clemson, L., & Boldy, D. 2013. Effectiveness of a lifestyle exercise program for older people receiving a restorative home care service: A pragmatic randomized controlled trial. Clinical Interventions in Aging, 8: 1591-1601. DOI: http://dx.doi.org/10.2147/CIA.S44614. Burton, E., Lewin, G., Clemson, L., & Boldy, D. 2013. Effectiveness of a lifestyle exercise program for older people receiving a restorative home care service: study protocol for a pragmatic randomised controlled trial. BMC Health Services Research, 13:419. DOI:10.1186/1472-6963-13-419. Burton, E., Lewin, G., Clemson, L. & Boldy, D. Effectiveness Of A Lifestyle Exercise Program For Older Restorative Home Care Clients, for 2013 Gerontological Society of America Annual Scientific Meeting, 20-24th November 2013, New Orleans, United States of American, Poster Presentation. Burton, E., Lewin, G., Clemson, L. & Boldy, D. Improving function of older people receiving a restorative care service, for 45th Australian Association of Gerontology National Conference, 20-23 November 2012, Brisbane Australia, Oral Presentation. Burton, E., Lewin, G., Clemson, L. & Boldy, D. Improving function of older people receiving a restorative care service, for 2012 Curtin Health Innovation Research Institute Conference, 8-9th November 2012, Perth Australia, Oral Presentation. Burton, E., Lewin, G., Clemson, L. & Boldy, D. Physical activity programs for older people receiving a restorative home care service, which is more effective? For the 4th International Congress on Physical Activity and Public Health "Active futures – Evidence informing change”, October 31-November 3, 2012, Sydney, Australia, Poster Presentation.
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Public notes
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Contacts
Principal investigator
Name
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Miss Elissa Burton
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Address
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School of Physiotherapy
Curtin University
GPO Box U1987
Bentley WA 6845
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Country
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Australia
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Phone
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61 08 9266 3681
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Fax
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Email
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[email protected]
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Contact person for public queries
Name
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Elissa Burton
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Address
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School of Physiotherapy
Curtin University
GPO Box U1987
Bentley WA 6845
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Country
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Australia
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Phone
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61 8 9266 6381
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Fax
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61 8 9266 2508
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Email
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[email protected]
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Contact person for scientific queries
Name
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Elissa Burton
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Address
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School of Physiotherapy
Curtin University
GPO Box U1987
Bentley WA 6845
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Country
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Australia
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Phone
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61 8 9266 3681
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Fax
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61 8 9266 2508
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Email
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[email protected]
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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
Source
Title
Year of Publication
DOI
Dimensions AI
Effectiveness of a lifestyle exercise program for older people receiving a restorative home care service: a pragmatic randomized controlled trial
2013
https://doi.org/10.2147/cia.s44614
Dimensions AI
Effectiveness of a lifestyle exercise program for older people receiving a restorative home care service: study protocol for a pragmatic randomised controlled trial
2013
https://doi.org/10.1186/1472-6963-13-419
N.B. These documents automatically identified may not have been verified by the study sponsor.
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