Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623001227684
Ethics application status
Approved
Date submitted
7/07/2023
Date registered
28/11/2023
Date last updated
28/11/2023
Date data sharing statement initially provided
28/11/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Validating the use of ultrasound for the measurement of muscle mass
Scientific title
Validity of ultrasound imaging versus magnetic resonance imaging for measuring anterior thigh and bicep muscles and subcutaneous fat in healthy adults
Secondary ID [1] 310072 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Malnutrition 330615 0
Condition category
Condition code
Diet and Nutrition 327450 327450 0 0
Other diet and nutrition disorders

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
The participants will be asked to wear or bring shorts and a t shirt and will be expected to be in the clinical research area for 2 hours in total, on one occasion. Participants will be landmarked at the right mid-bicep, right and left mid-thigh and 2/3 thigh. Researchers will use the Phillips Lumify Ultrasound portable ultrasound machine with the B-mode L12-4 linear array transducer. The MRI and US measurements will be taken on the same occasion. Trained staff at the Centre for Advanced MRI will conduct the take the MRI measurements. Three images will be taken at each site. The US images will be taken by research dietitians who have undergone training. There is only one ultrasound method.
Intervention code [1] 326477 0
Diagnosis / Prognosis
Comparator / control treatment
The participants will be required to be on site for a total of two hours on one occasion. MRI scans will be performed using a 3T Vida-Fit scanner (MAGNETOM, Siemens Healthineers; Erlangen, Germany) with a dedicated body coil. The participants will lie in a supine position with the right arm and both thighs in a neutral position. The landmarked positions and image processing will mimic the ultrasound protocol. Landmarks will be marked by placing a vitamin E capsule at the scan site. Trained staff at the Centre for Advanced MRI will conduct the take the MRI measurements. Three images will be taken at each site.
Control group
Active

Outcomes
Primary outcome [1] 335311 0
The primary outcome is the average muscle thickness across the following sites as a composite score. Participants will be landmarked at the right mid-bicep, right and left mid-thigh and 2/3 thigh. Philips Lumify (Philips Ultrasound, Bothall, WA) handheld portable B-mode L12-4 linear array transducer will be used to measure thickness of the bicep brachii of the arm and the rectus femoris of both legs at two points (1/2 way and 2/3 point).
Timepoint [1] 335311 0
During once off assessment
Secondary outcome [1] 423866 0
Participants will be landmarked at the right mid-bicep, right and left mid-thigh and 2/3 thigh as a composite score. Philips Lumify (Philips Ultrasound, Bothall, WA) handheld portable B-mode L12-4 linear array transducer will be used to measure cross sectional of the rectus femoris of both legs at the 2/3 point.
Timepoint [1] 423866 0
During once off assessment
Secondary outcome [2] 423868 0
Validity of the ultrasound muscle thickness using MRI muscle thickness
Timepoint [2] 423868 0
During once off assessment

Eligibility
Key inclusion criteria
Adults, healthy
Minimum age
20 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Diseases and conditions affecting muscles (structure or function), musculoskeletal injuries of the lower limb and pathologies including fractures, surgical procedures, cancer, or neurological disorders, and any issue that is a contraindication for MRI will also be excluded. Examples include cardiac implant, history of welding injury, cochlear or hearing implant, prosthetic limb, magnetic dental implant.

Study design
Purpose
Screening
Duration
Cross-sectional
Selection
Convenience sample
Timing
Prospective
Statistical methods / analysis
Test–retest and inter-rater reliability of ultrasound body composition measures will be assessed with intraclass correlation coefficient. Agreement between the ultrasound method and MRI measures will be assessed using Bland–Altman analysis and limits of agreement.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/01/2024
Actual
Date of last participant enrolment
Anticipated
29/02/2024
Actual
Date of last data collection
Anticipated
29/02/2024
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment outside Australia
Country [1] 25625 0
New Zealand
State/province [1] 25625 0

Funding & Sponsors
Funding source category [1] 314239 0
University
Name [1] 314239 0
The University of Auckland
Country [1] 314239 0
New Zealand
Primary sponsor type
University
Name
The University of Auckland
Address
Faculty of Medical and Health Science85 Park RoadGrafton, AucklandNew Zealand, 1145
Country
New Zealand
Secondary sponsor category [1] 316171 0
None
Name [1] 316171 0
Address [1] 316171 0
Country [1] 316171 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 313357 0
Auckland Health Research Ethics Committee
Ethics committee address [1] 313357 0
Ethics committee country [1] 313357 0
New Zealand
Date submitted for ethics approval [1] 313357 0
Approval date [1] 313357 0
04/07/2023
Ethics approval number [1] 313357 0

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

Contacts
Principal investigator
Name 127866 0
A/Prof Andrea Braakhuis
Address 127866 0
The University of Auckland Faculty of Medical and Health Science85 Park RoadGrafton, Auckland, 1145
Country 127866 0
New Zealand
Phone 127866 0
+61 9 223502926
Fax 127866 0
Email 127866 0
[email protected]
Contact person for public queries
Name 127867 0
Andrea Braakhuis
Address 127867 0
The University of Auckland Faculty of Medical and Health Science85 Park RoadGrafton, Auckland, 1145
Country 127867 0
New Zealand
Phone 127867 0
+61 9 223502926
Fax 127867 0
Email 127867 0
[email protected]
Contact person for scientific queries
Name 127868 0
Andrea Braakhuis
Address 127868 0
The University of Auckland Faculty of Medical and Health Science85 Park RoadGrafton, Auckland, 1145
Country 127868 0
New Zealand
Phone 127868 0
+61 9 223502926
Fax 127868 0
Email 127868 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Deidentified muscle thickness and cross sectional area
When will data be available (start and end dates)?
The data will be available on request for three years
Available to whom?
The PI will make the data available to individual research groups upon request
Available for what types of analyses?
For meta-analysis or standardisation of practice at other sites
How or where can data be obtained?
The data can be obtained upon request from the PI contactable via email [email protected]


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
19633Study protocol    Attached 386202-(Uploaded-19-07-2023-13-28-22)-Study-related document.docx



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.