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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
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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.
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Secondary ID [1]
279700
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Nil
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Universal Trial Number (UTN)
U1111-1127-0079
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Sarcopenia / sarcopaenia
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Chronic kidney disease
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Condition category
Condition code
Renal and Urogenital
285723
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0
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Kidney disease
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Musculoskeletal
285724
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0
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Other muscular and skeletal disorders
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Intervention/exposure
Study type
Observational
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Patient registry
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Target follow-up duration
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Target follow-up type
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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.
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Intervention code [1]
283993
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Not applicable
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Comparator / control treatment
Comparison of mortality rates in moderately and severely sarcopenic patients vs non-sarcopenic patients.
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Control group
Active
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Outcomes
Primary outcome [1]
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Morbidity and all cause mortality as assessed by data linkage to medical records
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Assessment method [1]
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Timepoint [1]
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9, 12 and 18 months after baseline data collection
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Secondary outcome [1]
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Morbidity and all cause mortality as assessed by data linkage to medical records
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Assessment method [1]
295444
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Timepoint [1]
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3 months after baseline clinical data collection
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Secondary outcome [2]
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Morbidity and all cause mortality as assessed by data linkage to medical records
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Assessment method [2]
295445
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Timepoint [2]
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6 months after baseline clinical data collection
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Eligibility
Key inclusion criteria
Dialysis patients
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Minimum age
60
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
Cardiac pacemaker or implanted defibrillator
Limb amputation
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Study design
Purpose
Screening
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Duration
Longitudinal
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Selection
Defined population
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Timing
Prospective
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Statistical methods / analysis
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Recruitment
Recruitment status
Active, not recruiting
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Date of first participant enrolment
Anticipated
21/12/2011
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Actual
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
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Sample size
Target
75
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
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Recruitment postcode(s) [1]
4851
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2145
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Recruitment postcode(s) [2]
4852
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2148
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Recruitment postcode(s) [3]
4853
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2750
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Funding & Sponsors
Funding source category [1]
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Hospital
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Name [1]
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Westmead Hospital
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Address [1]
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PO Box 533, Wentworthville, NSW, 2145
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Country [1]
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Australia
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Primary sponsor type
Individual
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Name
Associate Professor Grahame Elder
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Address
Department of Renal Medicine, Westmead Hospital
PO Box 533, Wentworthville, NSW, 2145
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Country
Australia
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Secondary sponsor category [1]
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Individual
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Name [1]
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Avalon Moonen
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Address [1]
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203/209 Albion St, Surry Hills, New South Wales
Univeristy of Notre Dame School of Medicine Sydney
16 Oxford St Darlinghurst, NSW, 2010
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Country [1]
283403
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Australia
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Other collaborator category [1]
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Individual
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Name [1]
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Sjorjiana Green
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Address [1]
260428
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University of Notre Dame School of Medicine Sydney
16 Oxford St Darlinghurst, NSW 2010
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Country [1]
260428
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Australia
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
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Sydney West Area Health Service Human Research Ethics Committee
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Ethics committee address [1]
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Westmead Hospital
PO Box 533, Wentworthville, NSW, 2145
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Ethics committee country [1]
286458
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Date submitted for ethics approval [1]
286458
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Approval date [1]
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17/11/2011
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Ethics approval number [1]
286458
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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.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
33611
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Address
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Associate Professor Grahame Elder
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Address
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Department of Renal Medicine, Westmead Hospital
PO Box 533, Wentworthville, NSW, 2145
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Country
16858
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Australia
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Phone
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+612 98456962
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Name
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Avalon Moonen
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Address
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203/209 Albion St, Surry Hills, NSW, 2010
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Country
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Australia
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Phone
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+61 (0)439997819
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Fax
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Email
7786
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[email protected]
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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
Source
Title
Year of Publication
DOI
Embase
Chronic kidney disease-related sarcopenia as a prognostic indicator in elderly haemodialysis patients.
2023
https://dx.doi.org/10.1186/s12882-023-03175-5
N.B. These documents automatically identified may not have been verified by the study sponsor.
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