Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618000570280
Ethics application status
Approved
Date submitted
6/04/2018
Date registered
13/04/2018
Date last updated
4/06/2019
Date data sharing statement initially provided
4/06/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
Prevalence of sarcopenia in inpatient rehabilitation.
Scientific title
Prevalence of sarcopenia in inpatient rehabilitation.
Secondary ID [1] 294495 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Sarcopenia
 307266 0
Inpatient rehabilitation 307267 0
Condition category
Condition code
Musculoskeletal 306385 306385 0 0
Other muscular and skeletal disorders
Physical Medicine / Rehabilitation 306386 306386 0 0
Other physical medicine / rehabilitation

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Patients admitted to inpatient rehabilitation will be tested for the presence of sarcopenia using the European Workings Group on Sarcopenia in Older People (EWGSOP) algorithm within one week of admission to inpatient rehabilitation
Intervention code [1] 300792 0
Not applicable
Comparator / control treatment
Not applicable
Control group
Uncontrolled

Outcomes
Primary outcome [1] 305393 0
Prevalence of sarcopenia using the European Working Group on Sarcopenia in Older People (EWGSOP) algorithm. Jamar dynamometer will be used to assess grip strength, and Body Impedance Analysis will be used to assess muscle mass
Timepoint [1] 305393 0
Within 1 week of admission to inpatient rehabilitation
Secondary outcome [1] 345469 0
We have no secondary outcome to report
Timepoint [1] 345469 0
N/A

Eligibility
Key inclusion criteria
Patients admitted to inpatient rehabilitation; patients having capacity to provide informed consent.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patient unable to undergo Body Impedance Analysis (BIA) testing.

Study design
Purpose
Screening
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
The aim of the study is to estimate the prevalence of sarcopenia in inpatient rehabilitation. This aim is of a statistical estimation nature, and no specific statistical hypothesis is being tested. As the result, the sample size is calculated based on precision, rather than statistical power considerations. The sample size of 150 patients would allow to estimate the population prevalence of 0.25 or 0.75 with the precision (maximum half width of 95% confidence interval) of 0.07; prevalence of 0.3 or 0.7 with the precision of 0.075; prevalence of 0.4 or 0.6 with the precision of 0.08; prevalence of 0.5 with the precision of 0.08.
The estimated prevalence will be reported as a proportion of patients with sarcopenia out of the total number of recruited patients with corresponding 95% confidence interval. Exploratory analysis of sarcopenia prevalence in diagnostic subgroups will be undertaken in a similar manner.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
30/11/2016
Date of last participant enrolment
Anticipated
30/07/2018
Actual
15/01/2019
Date of last data collection
Anticipated
7/08/2018
Actual
21/01/2019
Sample size
Target
150
Accrual to date
Final
203
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 10576 0
St Vincent's Hospital (Melbourne) Ltd - Fitzroy
Recruitment postcode(s) [1] 22295 0
3065 - Fitzroy

Funding & Sponsors
Funding source category [1] 299119 0
Hospital
Name [1] 299119 0
St Vincent's Hospital Melbourne
Country [1] 299119 0
Australia
Primary sponsor type
Individual
Name
Dr Irina Churilov
Address
St Vincent's Hospital Melbourne
41 Victoria Parade
Fitzroy 3065, Victoria
Country
Australia
Secondary sponsor category [1] 298378 0
University
Name [1] 298378 0
The University of Melbourne
Address [1] 298378 0
The University of Melbourne
Parkville 3010
Victoria
Country [1] 298378 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 300053 0
St Vincent's Hospital Melbourne
Ethics committee address [1] 300053 0
St Vincent's Hospital Melbourne
41 Victoria Parade
Fitzroy 3065, Victoria
Ethics committee country [1] 300053 0
Australia
Date submitted for ethics approval [1] 300053 0
19/07/2016
Approval date [1] 300053 0
18/10/2016
Ethics approval number [1] 300053 0
LLR 130/16

Summary
Brief summary
Background and justification. Inpatient rehabilitation is a hospital inpatient service that maximises patient's function prior to discharge from hospital by using an intensive daily therapy program. Sarcopenia is a medical condition characterized by low muscle mass and function, and it occurs in 5% to 50% of adults who live in the community (that is, not in hospitals, nursing homes or other institutions), depending on their age. Sarcopenia is associated with greater functional dependence and disability, which means that people who have it are more likely to need help from others or have difficulty with such basic everyday tasks as waling or taking a shower. The frequency with which sarcopenia occurs in inpatient rehabilitation is not known.
Aim. The aim of this project is to investigate the prevalence of sarcopenia (or the frequency with which it occurs) in inpatient rehabilitation.
Participant group. All cognitively intact patients who are admitted to inpatient rehabilitation unit of a tertiary referral inner metropolitan hospital will be eligible to participate in the study.
Method. The patients will be assessed for the presence of sarcopenia.
Expected outcomes. The anticipated outcome of this project is identifying the prevalence of sarcopenia in inpatient rehabilitation, both in the overall population and in diagnostic subgroups. Better understanding of this issue may lead to more appropriate clinical management of patients with sarcopenia in the setting of an inpatient rehabilitation unit.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 82402 0
Dr Irina Churilov
Address 82402 0
St Vincent's Hospital Melbourne
41 Victoria Parade
Fitzroy 3065
Victoria
Country 82402 0
Australia
Phone 82402 0
+61392312211
Fax 82402 0
Email 82402 0
[email protected]
Contact person for public queries
Name 82403 0
Irina Churilov
Address 82403 0
St Vincent's Hospital Melbourne
41 Victoria Parade
Fitzroy 3065
Victoria
Country 82403 0
Australia
Phone 82403 0
+61392312211
Fax 82403 0
Email 82403 0
[email protected]
Contact person for scientific queries
Name 82404 0
Irina Churilov
Address 82404 0
St Vincent's Hospital Melbourne
41 Victoria Parade
Fitzroy 3065
Victoria
Country 82404 0
Australia
Phone 82404 0
+61392312211
Fax 82404 0
Email 82404 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
Making this data available will present an unacceptable risk of patients being potentially identifiable due to a single centre nature of this study.


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
SourceTitleYear of PublicationDOI
EmbaseGripBMI - A fast and simple sarcopenia screening tool in post acute inpatient rehabilitation.2021https://dx.doi.org/10.1016/j.clnu.2020.06.034
N.B. These documents automatically identified may not have been verified by the study sponsor.