Trial Review

The ANZCTR website is back online for trial registration and updates. We apologise for any inconvenience caused while the site was inactive.


With activity expected to increase on the ANZCTR again, there may be extended wait times while we process pending studies, with priority being given to those trials submitted in February. Thank you for your patience.


Reset your password and enable multi-factor authentication (MFA)


For ANZCTR account holders: to help ensure the cyber safety of your account, you’ll need to reset your password and set-up multi-factor authentication (MFA) as per the instructions below.


  1. Go to the Login page, click ‘reset password’ and follow the instructions.
  2. Check your email for the link to set a new password.
  3. Create a new password that meets requirements.
  4. Return to the Login page and enter your new password. A verification code will be sent to your email.
  5. Check your email for the code and enter it on the Login page. If the code is entered incorrectly, you can re-enter the correct one or request a new one.

Learn more about MFA and its importance on the Australian Signals Directorate website.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12606000028505
Ethics application status
Approved
Date submitted
19/01/2006
Date registered
20/01/2006
Date last updated
20/01/2006
Type of registration
Prospectively registered

Titles & IDs
Public title
Validation of bioelectrical impedance as a measurement of body composition in older adults participating in rehabilitation
Scientific title
Validation of bioelectrical impedance as a measurement of body composition in older adults participating in rehabilitation
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Orthopedics 989 0
Neurological 990 0
Deconditioned 991 0
Condition category
Condition code
Neurological 1065 1065 0 0
Other neurological disorders
Physical Medicine / Rehabilitation 1066 1066 0 0
Other physical medicine / rehabilitation

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Measurement of body composition using bioelectrical impedance analysis and dual energy x-ray absorptiometry.
Intervention code [1] 850 0
None
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 1427 0
Fat free mass
Timepoint [1] 1427 0
Measured within 10 days of subject recruitment
Secondary outcome [1] 2521 0
Fat mass
Timepoint [1] 2521 0
Measured within 10 days of subject recruitment.

Eligibility
Key inclusion criteria
No terminal or acute illnessNo peripheral oedema or dehydrationNo pacemaker.
Minimum age
65 Years
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
No exclusion criteria

Study design
Purpose
Screening
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/05/2006
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
120
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 1165 0
Self funded/Unfunded
Name [1] 1165 0
Country [1] 1165 0
Primary sponsor type
Individual
Name
Michelle Miller
Address
Country
Secondary sponsor category [1] 1026 0
Individual
Name [1] 1026 0
Maria Crotty
Address [1] 1026 0
Country [1] 1026 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 2483 0
Application pending with Repatriation General Hospital Ethics Committee
Ethics committee address [1] 2483 0
Ethics committee country [1] 2483 0
Australia
Date submitted for ethics approval [1] 2483 0
Approval date [1] 2483 0
Ethics approval number [1] 2483 0

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

Contacts
Principal investigator
Name 35151 0
Address 35151 0
Country 35151 0
Phone 35151 0
Fax 35151 0
Email 35151 0
Contact person for public queries
Name 10039 0
Michelle Miller
Address 10039 0
Department of Nutrition & Dietetics Flinders University G4 Flinders Medical Centre (FMC) Flats Flinders Drive Bedford Park SA 5042
Country 10039 0
Australia
Phone 10039 0
+61 8 82045328
Fax 10039 0
Email 10039 0
[email protected]
Contact person for scientific queries
Name 967 0
Michelle Miller
Address 967 0
Department of Nutrition & Dietetics Flinders University G4 Flinders Medical Centre (FMC) Flats Flinders Drive Bedford Park SA 5042
Country 967 0
Australia
Phone 967 0
+61 8 82045328
Fax 967 0
Email 967 0
[email protected]

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.