Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612000048886
Ethics application status
Approved
Date submitted
10/01/2012
Date registered
10/01/2012
Date last updated
11/05/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
Sarcopenia (loss of muscle mass and function) and physical performance as predictors of clinical outcome in patients on dialysis
Scientific title
A prospective longitudinal study investigating the effect of sarcopenia and physical performance on 9, 12 and 18 month morbidity and mortality in dialysis patients aged over 60 years.
Secondary ID [1] 279700 0
Nil
Universal Trial Number (UTN)
U1111-1127-0079
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Sarcopenia / sarcopaenia 285532 0
Chronic kidney disease 285533 0
Condition category
Condition code
Renal and Urogenital 285723 285723 0 0
Kidney disease
Musculoskeletal 285724 285724 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Measurement of: - biochemical parameters by serum assay of albumin, haematocrit, urea, cholesterol, CRP, transferrin, TNF-alpha - muscle mass using a Fresenius bioimpedance spectrometer - muscle strength using Jamar hand dynamometer for grip strength and isometric muscle strength dynamometer for leg extension - functional muscle capacity using repeated chair stands, timed up-and-go, and 6 minute walk test - subjective nutritional status assessment using the validated "Subjective Global Analysis" questionnaire.
Testing is performed during a single 45 minute assessment session at baseline, biochemical results are accessed from medical records, and TNF-alpha will be assayed from serum samples.
Intervention code [1] 283993 0
Not applicable
Comparator / control treatment
Comparison of mortality rates in moderately and severely sarcopenic patients vs non-sarcopenic patients.
Control group
Active

Outcomes
Primary outcome [1] 286244 0
Morbidity and all cause mortality as assessed by data linkage to medical records
Timepoint [1] 286244 0
9, 12 and 18 months after baseline data collection
Secondary outcome [1] 295444 0
Morbidity and all cause mortality as assessed by data linkage to medical records
Timepoint [1] 295444 0
3 months after baseline clinical data collection
Secondary outcome [2] 295445 0
Morbidity and all cause mortality as assessed by data linkage to medical records
Timepoint [2] 295445 0
6 months after baseline clinical data collection

Eligibility
Key inclusion criteria
Dialysis patients
Minimum age
60 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Cardiac pacemaker or implanted defibrillator
Limb amputation

Study design
Purpose
Screening
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
21/12/2011
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
75
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 4851 0
2145
Recruitment postcode(s) [2] 4852 0
2148
Recruitment postcode(s) [3] 4853 0
2750

Funding & Sponsors
Funding source category [1] 284477 0
Hospital
Name [1] 284477 0
Westmead Hospital
Country [1] 284477 0
Australia
Primary sponsor type
Individual
Name
Associate Professor Grahame Elder
Address
Department of Renal Medicine, Westmead Hospital
PO Box 533, Wentworthville, NSW, 2145
Country
Australia
Secondary sponsor category [1] 283403 0
Individual
Name [1] 283403 0
Avalon Moonen
Address [1] 283403 0
203/209 Albion St, Surry Hills, New South Wales

Univeristy of Notre Dame School of Medicine Sydney
16 Oxford St Darlinghurst, NSW, 2010
Country [1] 283403 0
Australia
Other collaborator category [1] 260428 0
Individual
Name [1] 260428 0
Sjorjiana Green
Address [1] 260428 0
University of Notre Dame School of Medicine Sydney
16 Oxford St Darlinghurst, NSW 2010
Country [1] 260428 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 286458 0
Sydney West Area Health Service Human Research Ethics Committee
Ethics committee address [1] 286458 0
Westmead Hospital
PO Box 533, Wentworthville, NSW, 2145
Ethics committee country [1] 286458 0
Date submitted for ethics approval [1] 286458 0
Approval date [1] 286458 0
17/11/2011
Ethics approval number [1] 286458 0

Summary
Brief summary
A research study into how muscle bulk, strength and physical performance predict clinical outcomes in patients on dialysis.
If the hypothesis proves to be correct, then these simple tests could be used when people are on dialysis or considering commencing dialysis. The results could highlight patients at increased risk of suffering medical complications during dialysis treatments.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 33611 0
Address 33611 0
Country 33611 0
Phone 33611 0
Fax 33611 0
Email 33611 0
Contact person for public queries
Name 16858 0
Associate Professor Grahame Elder
Address 16858 0
Department of Renal Medicine, Westmead Hospital
PO Box 533, Wentworthville, NSW, 2145
Country 16858 0
Australia
Phone 16858 0
+612 98456962
Fax 16858 0
Email 16858 0
g.elder@garvan.unsw.edu.au
Contact person for scientific queries
Name 7786 0
Avalon Moonen
Address 7786 0
203/209 Albion St, Surry Hills, NSW, 2010
Country 7786 0
Australia
Phone 7786 0
+61 (0)439997819
Fax 7786 0
Email 7786 0
avalon.m@hotmail.com

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
SourceTitleYear of PublicationDOI
EmbaseChronic kidney disease-related sarcopenia as a prognostic indicator in elderly haemodialysis patients.2023https://dx.doi.org/10.1186/s12882-023-03175-5
N.B. These documents automatically identified may not have been verified by the study sponsor.