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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ANZCTR
Last refreshed on: 13 January 2020
Main ID:  ACTRN12605000101684
Date of registration: 09/08/2005
Prospective Registration: No
Primary sponsor: Kidney Health Australia
Public title: Progressive Exercise for Anabolism in Kidney Disease
Scientific title: A randomized phase III study to evaluate the effects of progressive resistance training in the treatment of muscle wasting to improve physical function and quality of life in end stage renal disease
Date of first enrolment: 01/10/2002
Target sample size: 50
Recruitment status: Active, not recruiting
URL:  https://anzctr.org.au/ACTRN12605000101684.aspx
Study type:  Interventional
Study design:  Purpose: Treatment; Allocation: Randomised controlled trial; Masking: Open (masking not used);Assignment: Crossover;Type of endpoint: Safety/efficacy;  
Phase:  Phase 1
Countries of recruitment
Australia
Contacts
Name: Maria Fiatarone Singh   
Address:  University of Sydney Cumberland Campus East Street Lidcombe NSW 2141 Australia
Telephone: +61 2 93519755
Email: m.singh@fhs.usyd.edu.au
Affiliation: 
Name: Maria Fiatarone Singh   
Address:  University of Sydney Cumberland Campus PO Box 170 Lidcombe NSW 1825 Australia
Telephone: +61 2 93519755
Email: m.singh@fhs.usyd.edu.au
Affiliation: 
Key inclusion & exclusion criteria
Inclusion criteria: Stable hemodialysis patients with no contraindications to progressive resistance training.
Exclusion criteria: No exclusion criteria

Age minimum: Not stated
Age maximum: Not stated
Gender: Both males and females
Health Condition(s) or Problem(s) studied
End stage renal disease;
End stage renal disease
Renal and Urogenital - Other renal and urogenital disorders
Musculoskeletal - Other muscular and skeletal disorders
Intervention(s)
The experimental grroup will receive progressive Resistance Training for 24 weeks in addition to usual care.
Primary Outcome(s)
Skeletal muscle cross-sectional area and attenuation[Measured at baseline, week 12 and week 24]
Secondary Outcome(s)
C-reactive protein[Measured at baseline, week 12 and week 24.]
Dialysis Adequacy (Kt/V)[Measured at baseline, week 12 and week 24.]
Geriatric Depression Scale (GDS)[Measured at baseline, week 12 and week 24.]
Static balance[Measured at baseline, week 12 and week 24.]
Haemotological markers[Measured at baseline, week 12 and week 24.]
Isometric muscular strength[Measured at baseline, week 12 and week 24.]
Mini-nutritional assessment (MNA),[Measured at baseline, week 12 and week 24.]
Protein Catabolic Rate[Measured at baseline, week 12 and week 24.]
Physical Activity Scale for the Elderly (PASE)[Measured at baseline, week 12 and week 24.]
Dietary Intake (Australian Food Frequency Questionnaire).[Measured at baseline, week 12 and week 24.]
6-minute walk[Measured at baseline, week 12 and week 24.]
Quality of Life (SF-36)[Measured at baseline, week 12 and week 24.]
Secondary ID(s)
Source(s) of Monetary Support
University of Sydney
Simbex Technologies
NHMRC
Kidney Health Australia
Secondary Sponsor(s)
University of Sydney
Ethics review
Status: Not approved
Approval date:
Contact:
RPAH
Status: Not approved
Approval date:
Contact:
SESAHS
Status: Not approved
Approval date:
Contact:
USYD
Results
Results available:
Date Posted:
Date Completed:
URL:
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