Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611000788976
Ethics application status
Yes
Date submitted
27/07/2011
Date registered
27/07/2011
Date last updated
Type of registration
Prospectively registered

Titles & IDs
Public title
Physical Activity for Older Home Care Clients Receiving a Restorative Care Program
Scientific title
A randomised controlled trial to test the effectiveness of two physical activity programs for older people receiving a restorative care program
Secondary ID [1] 252398 0
Nil
Universal Trial Number (UTN)
U1111-1116-4526
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Functional-mobility for older home care clients 257910 0
Condition category
Condition code
Physical Medicine / Rehabilitation 258076 258076 0 0
Other physical medicine / rehabilitation

Intervention/exposure
Study type
Interventional
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).
Intervention code [1] 256964 0
Prevention
Intervention code [2] 256965 0
Rehabilitation
Intervention code [3] 256966 0
Lifestyle
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.
Control group
Active

Outcomes
Primary outcome [1] 258936 0
Functional mobility using timed up and go
Timepoint [1] 258936 0
at baseline, 8 weeks and 6 months after intervention commencement
Secondary outcome [1] 265107 0
Balance using the tandem walk and functional reach tests
Timepoint [1] 265107 0
at baseline, 8 weeks and 6 months after intervention commencement
Secondary outcome [2] 279351 0
Sit to stand test to determine lower body strength
Timepoint [2] 279351 0
at baseline, 8 weeks and 6 months after intervention commencement
Secondary outcome [3] 279352 0
Falls efficacy scale to test balance confidence
Timepoint [3] 279352 0
at baseline, 8 weeks and 6 months after intervention commencement
Secondary outcome [4] 279353 0
Activities balance confidence scale to determine balance confidence for more challenging activities
Timepoint [4] 279353 0
at baseline, 8 weeks and 6 months after intervention commencement
Secondary outcome [5] 279354 0
Vitality plus scale to test psychological well-being
Timepoint [5] 279354 0
at baseline, 8 weeks and 6 months after intervention commencement
Secondary outcome [6] 279355 0
Late life function and disability scale to test function and disability levels of participants
Timepoint [6] 279355 0
at baseline, 8 weeks and 6 months after intervention commencement
Secondary outcome [7] 299637 0
Timed up and Go to tests mobility
Timepoint [7] 299637 0
at baseline, 8 weeks and 6 months after intervention

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.
Minimum age
65 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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.

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)
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
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
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
10/08/2011
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
150
Accrual to date
Final
Recruitment outside Australia
Country [1] 259949 0
State/province [1] 259949 0

Funding & Sponsors
Funding source category [1] 257416 0
Government funding body e.g. Australian Research Council
Name [1] 257416 0
Healthway
Country [1] 257416 0
Australia
Primary sponsor type
Individual
Name
Elissa Burton
Address
Centre for Research on Ageing
Curtin University
GPO Box U1987
Perth WA Australia 6845
Country
Australia
Secondary sponsor category [1] 256649 0
Individual
Name [1] 256649 0
Professor Gill Lewin
Address [1] 256649 0
Centre for Research on Ageing
Curtin University
GPO Box U1987
Perth WA Australia 6845
Country [1] 256649 0
Australia

Ethics approval
Ethics application status
Yes
Ethics committee name [1] 259441 0
Silver Chain Human Research Ethics Committee
Ethics committee address [1] 259441 0
6 Sundercombe Street
Osborne Park WA 6017
Ethics committee country [1] 259441 0
Australia
Date submitted for ethics approval [1] 259441 0
Approval date [1] 259441 0
26/10/2010
Ethics approval number [1] 259441 0
EC App 065
Ethics committee name [2] 269495 0
Curtin University Human Research Ethics Committee
Ethics committee address [2] 269495 0
GPO Box U1987
Perth WA 6845
Ethics committee country [2] 269495 0
Australia
Date submitted for ethics approval [2] 269495 0
Approval date [2] 269495 0
16/11/2010
Ethics approval number [2] 269495 0
HR 145/2010

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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Contact person for public queries
Contact person for scientific queries

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.