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Trial registered on ANZCTR
Registration number
ACTRN12618000315213p
Ethics application status
Submitted, not yet approved
Date submitted
26/02/2018
Date registered
2/03/2018
Date last updated
2/03/2018
Type of registration
Prospectively registered
Titles & IDs
Public title
Active@Home: Implementing a home exercise program for older people receiving in-home care services.
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Scientific title
Active@Home: The effect of a home exercise program on physical function for people over 65 years receiving in-home care services.
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Secondary ID [1]
294154
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None
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Universal Trial Number (UTN)
U1111-1209-8837
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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:
Sarcopenia
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Ageing
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Condition category
Condition code
Physical Medicine / Rehabilitation
305883
305883
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0
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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
An in-home exercise program delivered by the participant's personal care worker and consisting of 8 basic exercises to improve strength and physical function. The program will be supported by a resource booklet and a client app to maximise motivation. The program will run for 6 months with assessments of physical function and quality of life before starting, at 3 months and at 6 months. The 8 exercise are; chair stand, seated leg extension, standing calf raise, wall push-ups, Theraband seated row, single leg stand, tight rope walk and side-to-side step. Participants will be encouraged to complete the 8 exercises at least twice a week for the 6 months. Exercise duration is approximately 30 minutes. Administration by care workers will be one-on-one and face-to-face at scheduled care visits. Care workers will be trained and assist participants with goal setting and motivation. Care workers will provide motivation at scheduled visits. Participants will record exercise sessions in the app or on a fridge mounted diary (for non-app users). The resource booklet is designed specifically to support this study. Participants will bring their own devices, those who do not have a suitable device will use the resource booklet and fridge diary.
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Intervention code [1]
300445
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Lifestyle
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Intervention code [2]
300456
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Prevention
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Intervention code [3]
300457
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Rehabilitation
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Comparator / control treatment
No control group
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Control group
Uncontrolled
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Outcomes
Primary outcome [1]
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Change in Short Physical Performance Battery score
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Assessment method [1]
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Timepoint [1]
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Before the intervention, and at 3 months and 6 months (primary endpoint) post intervention start
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Secondary outcome [1]
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Change in Medical Outcomes Survey Short Form 36 - physical functioning scale
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Assessment method [1]
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Timepoint [1]
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Before the intervention, and at 3 months and 6 months (secondary endpoint) post intervention start
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Eligibility
Key inclusion criteria
Aged 65 years or older.
Receiving in-home care services.
Independently mobile,
Have the capacity to give signed, personal informed consent.
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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?
Yes
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Key exclusion criteria
Not independently mobile.
Unable to give informed consent.
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Study design
Purpose of the study
Prevention
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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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
Single group
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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
Paired t-tests.
Correlation.
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Recruitment
Recruitment status
Not yet recruiting
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Date of first participant enrolment
Anticipated
16/04/2018
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Actual
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
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Sample size
Target
50
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC
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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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Brisbane North PHN Aged Care Consortium
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Address [1]
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543 Lutwyche Road
PO Box 845
Lutwyche, Qld, 4030
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Country [1]
298792
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Australia
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Primary sponsor type
Government body
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Name
Brisbane North PHN Aged Care Consortium
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Address
543 Lutwyche Road
PO Box 845
Lutwyche, Qld, 4030
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Country
Australia
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Secondary sponsor category [1]
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University
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Name [1]
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The University of Queensland
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Address [1]
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Faculty of Health and Behavioural Sciences
School of Nursing, Midwifery & Social Work
Room 335A I Chamberlain Building I St Lucia Campus
The University of Queensland
Queensland 4072
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Country [1]
297976
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Australia
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Ethics approval
Ethics application status
Submitted, not yet approved
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Ethics committee name [1]
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University of Queensland
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Ethics committee address [1]
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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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05/02/2018
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Approval date [1]
299736
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Ethics approval number [1]
299736
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Summary
Brief summary
Exercise has proven health benefits for older people regardless of age, ability or disease status. However, for many older people, there are substantial barriers to regular exercise participation. These include access to facilities and age-appropriate programs and restricted transport options that prevent older people from attending both social and physical activities.The aim of this study is to evaluate a model of care which has a preventative focus and will enable long-term exercise delivery and support within existing in-home care funding. The primary aim of this study is to improve the functional capacity of participants thereby increasing their ability to engage in activities of daily living.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Dr Anthony Tuckett
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Address
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Faculty of Health and Behavioural Sciences I School of Nursing, Midwifery & Social Work
Room 335A I Chamberlain Building I St Lucia Campus
The University of Queensland
Queensland 4072
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Country
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Australia
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Phone
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+6173346 6787
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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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Dr Sharon Hetherington
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Address
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Burnie Brae
60 Kuran Street
Chermside
Queensland4032
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Country
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Australia
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Phone
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+61736242186
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Fax
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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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Dr Sharon Hetherington
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Address
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Burnie Brae
60 Kuran Street
Chermside
Queensland 4032
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Country
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Australia
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Phone
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+61736242186
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Fax
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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
No additional documents have been identified.
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