Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621000122853
Ethics application status
Approved
Date submitted
5/11/2020
Date registered
8/02/2021
Date last updated
23/02/2023
Date data sharing statement initially provided
8/02/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Prevalence of sarcopenia in an Australian geriatric Medical Assessment Unit (MAU)
Scientific title
Prevalence of sarcopenia in an Australian geriatric Medical Assessment Unit (MAU)
Secondary ID [1] 302711 0
None
Universal Trial Number (UTN)
U1111-1260-8478
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
sarcopenia 319625 0
Condition category
Condition code
Musculoskeletal 317566 317566 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Older adults admitted to an Australian geriatric Medical Assessment Unit (MAU) will be assessed for the presence of sarcopenia using the European Workings Group on Sarcopenia in Older People (EWGSOP) algorithm within 72 hours of admission to the MAU. This assessment will be completed once after consent is gained, there is no follow-up of participants.

Sarcopenia is a progressive and generalised syndrome of skeletal muscles that involves accelerated loss of muscle function (defined by strength, power or physical performance) and mass.
Intervention code [1] 318990 0
Not applicable
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 325611 0
Prevalence of sarcopenia in older adults admitted to an Australian geriatric Medical Assessment Unit (MAU) using the European Working Group on Sarcopenia in Older People’s (EWGSOP) algorithm.

This is a composite primary outcome, and includes:
Grip strength, which will be assessed using a Jamar dynamometer,
Muscle Mass, which will be assessed using a Impedimed Sozo Bioimpedance Spectroscopy (BIS),
Gait speed, which will be assessed using the 6m walk test..
Timepoint [1] 325611 0
Within 72 hours of admission to the MAU.
Secondary outcome [1] 388557 0
Nil
Timepoint [1] 388557 0
Nil

Eligibility
Key inclusion criteria
- Aged 65 years or older
- Admitted to the Prince of Wales Hospital geriatric MAU during the study period
- Able to provide written consent, or has a suitable representative that can provide consent on their behalf (e.g. power of attorney, family member)
Minimum age
65 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- On end of life care pathway or terminally ill
- Severe medical or psychology diagnosis that would prevent participation in the sarcopenia assessment.

Study design
Purpose
Screening
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
Sample size calculation:
The primary aim of this study is to determine the estimated prevalence of sarcopenia in an Australian geriatric MAU. Therefore, a precision-based sample size calculation has been used. An estimated prevalence of 0.38 (based on previous research) with the precision of 0.076 (95% confidence interval) was selected to determine the target sample size.

Analysis plan:
The estimated prevalence of sarcopenia will be reported as a proportion of the total study population with 95% confidence interval. Descriptive analyses and regression modelling will be used to quantitatively examine the study variables and potential associations.

Recruitment
Recruitment status
Stopped early
Data analysis
No data analysis planned
Reason for early stopping/withdrawal
Lack of funding/staff/facilities
Other reasons/comments
Other reasons
The MAU was the ward used for recruitment and the focus of this study. However, as part of the hospital's COVID-19 response MAU was disbanded. Following that a new section of the hospital was developed with no plan to reinstate MAU.
Date of first participant enrolment
Anticipated
22/02/2021
Actual
23/02/2021
Date of last participant enrolment
Anticipated
30/06/2021
Actual
19/08/2021
Date of last data collection
Anticipated
30/07/2021
Actual
31/08/2021
Sample size
Target
157
Accrual to date
Final
48
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 17959 0
Prince of Wales Hospital - Randwick
Recruitment postcode(s) [1] 31833 0
2031 - Randwick

Funding & Sponsors
Funding source category [1] 307142 0
University
Name [1] 307142 0
Macquarie University
Country [1] 307142 0
Australia
Primary sponsor type
Individual
Name
Dr Lindsey Brett
Address
Department of Health Professions
Faculty of Medicine, Health and Human Sciences
Macquarie University
Ground floor, 75 Talavera Road
Macquarie University
NSW 2109
Country
Australia
Secondary sponsor category [1] 307735 0
None
Name [1] 307735 0
N/A
Address [1] 307735 0
N/A
Country [1] 307735 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 307255 0
South Eastern Sydney Local Health District Human Research Ethics Committee
Ethics committee address [1] 307255 0
Ethics committee country [1] 307255 0
Australia
Date submitted for ethics approval [1] 307255 0
07/10/2020
Approval date [1] 307255 0
21/01/2021
Ethics approval number [1] 307255 0
2020/ETH01824

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

Contacts
Principal investigator
Name 106582 0
Dr Lindsey Brett
Address 106582 0
Department of Health Professions
Faculty of Medicine, Health and Human Sciences
Macquarie University
Ground floor, 75 Talavera Road
Macquarie University
NSW 2109
Country 106582 0
Australia
Phone 106582 0
+61 2 9850 2487
Fax 106582 0
Email 106582 0
[email protected]
Contact person for public queries
Name 106583 0
Lindsey Brett
Address 106583 0
Department of Health Professions
Faculty of Medicine, Health and Human Sciences
Macquarie University
Ground floor, 75 Talavera Road
Macquarie University
NSW 2109
Country 106583 0
Australia
Phone 106583 0
+61 2 9850 2487
Fax 106583 0
Email 106583 0
[email protected]
Contact person for scientific queries
Name 106584 0
Lindsey Brett
Address 106584 0
Department of Health Professions
Faculty of Medicine, Health and Human Sciences
Macquarie University
Ground floor, 75 Talavera Road
Macquarie University
NSW 2109
Country 106584 0
Australia
Phone 106584 0
+61 2 9850 2487
Fax 106584 0
Email 106584 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
As per the study protocol and consent form, individual participant data will not be available.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
9647Ethical approval    380881-(Uploaded-03-02-2021-08-49-14)-Study-related document.pdf



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.