Trial Review

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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.
Scientific title
Active@Home: The effect of a home exercise program on physical function for people over 65 years receiving in-home care services.
Secondary ID [1] 294154 0
None
Universal Trial Number (UTN)
U1111-1209-8837
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Sarcopenia 306780 0
Ageing 306802 0
Condition category
Condition code
Physical Medicine / Rehabilitation 305883 305883 0 0
Other physical medicine / rehabilitation

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 300445 0
Lifestyle
Intervention code [2] 300456 0
Prevention
Intervention code [3] 300457 0
Rehabilitation
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 304925 0
Change in Short Physical Performance Battery score
Timepoint [1] 304925 0
Before the intervention, and at 3 months and 6 months (primary endpoint) post intervention start
Secondary outcome [1] 343626 0
Change in Medical Outcomes Survey Short Form 36 - physical functioning scale
Timepoint [1] 343626 0
Before the intervention, and at 3 months and 6 months (secondary endpoint) post intervention start

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.
Minimum age
65 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Not independently mobile.
Unable to give informed consent.

Study design
Purpose of the study
Prevention
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Paired t-tests.
Correlation.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
16/04/2018
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
50
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 298792 0
Government body
Name [1] 298792 0
Brisbane North PHN Aged Care Consortium
Country [1] 298792 0
Australia
Primary sponsor type
Government body
Name
Brisbane North PHN Aged Care Consortium
Address
543 Lutwyche Road
PO Box 845
Lutwyche, Qld, 4030
Country
Australia
Secondary sponsor category [1] 297976 0
University
Name [1] 297976 0
The University of Queensland
Address [1] 297976 0
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
Country [1] 297976 0
Australia

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 299736 0
University of Queensland
Ethics committee address [1] 299736 0
Ethics committee country [1] 299736 0
Australia
Date submitted for ethics approval [1] 299736 0
05/02/2018
Approval date [1] 299736 0
Ethics approval number [1] 299736 0

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

Contacts
Principal investigator
Name 81410 0
Dr Anthony Tuckett
Address 81410 0
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
Country 81410 0
Australia
Phone 81410 0
+6173346 6787
Fax 81410 0
Email 81410 0
a.tuckett@uq.edu.au
Contact person for public queries
Name 81411 0
Sharon Hetherington
Address 81411 0
Burnie Brae
60 Kuran Street
Chermside
Queensland4032
Country 81411 0
Australia
Phone 81411 0
+61736242186
Fax 81411 0
Email 81411 0
hetherington.s@burniebrae.org.au
Contact person for scientific queries
Name 81412 0
Sharon Hetherington
Address 81412 0
Burnie Brae
60 Kuran Street
Chermside
Queensland 4032
Country 81412 0
Australia
Phone 81412 0
+61736242186
Fax 81412 0
Email 81412 0
hetherington.s@burniebrae.org.au

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.