ANZCTR - Registration

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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]

None

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Sarcopenia

Inpatient rehabilitation

Condition category

Condition code

Musculoskeletal

Other muscular and skeletal disorders

Physical Medicine / Rehabilitation

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]

Not applicable

Comparator / control treatment

Not applicable

Control group

Uncontrolled

Outcomes

Primary outcome [1]

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]

Within 1 week of admission to inpatient rehabilitation

Secondary outcome [1]

We have no secondary outcome to report

Timepoint [1]

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?

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]

St Vincent's Hospital (Melbourne) Ltd - Fitzroy

Recruitment postcode(s) [1]

3065 - Fitzroy

Funding & Sponsors

Funding source category [1]

Hospital

Name [1]

St Vincent's Hospital Melbourne

Address [1]

St Vincent's Hospital Melbourne
41 Victoria Parade
Fitzroy 3065, Victoria

Country [1]

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]

University

Name [1]

The University of Melbourne

Address [1]

The University of Melbourne
Parkville 3010
Victoria

Country [1]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

St Vincent's Hospital Melbourne

Ethics committee address [1]

St Vincent's Hospital Melbourne
41 Victoria Parade
Fitzroy 3065, Victoria

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

19/07/2016

Approval date [1]

18/10/2016

Ethics approval number [1]

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

Dr Irina Churilov

Address

St Vincent's Hospital Melbourne
41 Victoria Parade
Fitzroy 3065
Victoria

Country

Australia

Phone

+61392312211

Fax

[email protected]

Contact person for public queries

Name

Irina Churilov

Address

St Vincent's Hospital Melbourne
41 Victoria Parade
Fitzroy 3065
Victoria

Country

Australia

Phone

+61392312211

Fax

[email protected]

Contact person for scientific queries

Name

Irina Churilov

Address

St Vincent's Hospital Melbourne
41 Victoria Parade
Fitzroy 3065
Victoria

Country

Australia

Phone

+61392312211

Fax

[email protected]

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

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

Source	Title	Year of Publication	DOI
Embase	GripBMI - A fast and simple sarcopenia screening tool in post acute inpatient rehabilitation.	2021	https://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.

Trial Review

Documents added manually

Documents added automatically