Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Trial Review
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
Download to PDF
Trial registered on ANZCTR
Registration number
ACTRN12605000101684
Ethics application status
Approved
Date submitted
2/08/2005
Date registered
9/08/2005
Date last updated
16/09/2013
Type of registration
Retrospectively registered
Titles & IDs
Public title
Progressive Exercise for Anabolism in Kidney Disease
Query!
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
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
End stage renal disease
182
0
Query!
Condition category
Condition code
Renal and Urogenital
206
206
0
0
Query!
Other renal and urogenital disorders
Query!
Musculoskeletal
207
207
0
0
Query!
Other muscular and skeletal disorders
Query!
Intervention/exposure
Study type
Interventional
Query!
Description of intervention(s) / exposure
The experimental grroup will receive progressive Resistance Training for 24 weeks in addition to usual care.
Query!
Intervention code [1]
103
0
Treatment: Other
Query!
Comparator / control treatment
Control group will be wait-listed for 12 weeks receiving usual care only prior to receiving progressive resistance training + usual care for 12 weeks.
Query!
Control group
Active
Query!
Outcomes
Primary outcome [1]
246
0
Skeletal muscle cross-sectional area and attenuation
Query!
Assessment method [1]
246
0
Query!
Timepoint [1]
246
0
Measured at baseline, week 12 and week 24
Query!
Secondary outcome [1]
553
0
6-minute walk
Query!
Assessment method [1]
553
0
Query!
Timepoint [1]
553
0
Measured at baseline, week 12 and week 24.
Query!
Secondary outcome [2]
554
0
Isometric muscular strength
Query!
Assessment method [2]
554
0
Query!
Timepoint [2]
554
0
Measured at baseline, week 12 and week 24.
Query!
Secondary outcome [3]
555
0
Static balance
Query!
Assessment method [3]
555
0
Query!
Timepoint [3]
555
0
Measured at baseline, week 12 and week 24.
Query!
Secondary outcome [4]
556
0
Geriatric Depression Scale (GDS)
Query!
Assessment method [4]
556
0
Query!
Timepoint [4]
556
0
Measured at baseline, week 12 and week 24.
Query!
Secondary outcome [5]
557
0
Quality of Life (SF-36)
Query!
Assessment method [5]
557
0
Query!
Timepoint [5]
557
0
Measured at baseline, week 12 and week 24.
Query!
Secondary outcome [6]
558
0
Physical Activity Scale for the Elderly (PASE)
Query!
Assessment method [6]
558
0
Query!
Timepoint [6]
558
0
Measured at baseline, week 12 and week 24.
Query!
Secondary outcome [7]
559
0
Haemotological markers
Query!
Assessment method [7]
559
0
Query!
Timepoint [7]
559
0
Measured at baseline, week 12 and week 24.
Query!
Secondary outcome [8]
560
0
C-reactive protein
Query!
Assessment method [8]
560
0
Query!
Timepoint [8]
560
0
Measured at baseline, week 12 and week 24.
Query!
Secondary outcome [9]
561
0
Dialysis Adequacy (Kt/V)
Query!
Assessment method [9]
561
0
Query!
Timepoint [9]
561
0
Measured at baseline, week 12 and week 24.
Query!
Secondary outcome [10]
562
0
Mini-nutritional assessment (MNA),
Query!
Assessment method [10]
562
0
Query!
Timepoint [10]
562
0
Measured at baseline, week 12 and week 24.
Query!
Secondary outcome [11]
563
0
Protein Catabolic Rate
Query!
Assessment method [11]
563
0
Query!
Timepoint [11]
563
0
Measured at baseline, week 12 and week 24.
Query!
Secondary outcome [12]
564
0
Dietary Intake (Australian Food Frequency Questionnaire).
Query!
Assessment method [12]
564
0
Query!
Timepoint [12]
564
0
Measured at baseline, week 12 and week 24.
Query!
Eligibility
Key inclusion criteria
Stable hemodialysis patients with no contraindications to progressive resistance training.
Query!
Minimum age
Not stated
Query!
Query!
Maximum age
Not stated
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
Key exclusion criteria
No exclusion criteria
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
Randomised controlled trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
concealed opaque envelope. Assignment following baseline testing.
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
computer-generated randomization list
Query!
Masking / blinding
Open (masking not used)
Query!
Who is / are masked / blinded?
Query!
Query!
Query!
Query!
Intervention assignment
Crossover
Query!
Other design features
RCT
Query!
Phase
Phase 1
Query!
Type of endpoint/s
Safety/efficacy
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Active, not recruiting
Query!
Date of first participant enrolment
Anticipated
1/10/2002
Query!
Actual
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
Query!
Actual
Query!
Sample size
Target
50
Query!
Accrual to date
Query!
Final
Query!
Recruitment in Australia
Recruitment state(s)
Query!
Funding & Sponsors
Funding source category [1]
260
0
Government body
Query!
Name [1]
260
0
NHMRC
Query!
Address [1]
260
0
Query!
Country [1]
260
0
Australia
Query!
Funding source category [2]
261
0
University
Query!
Name [2]
261
0
University of Sydney
Query!
Address [2]
261
0
Query!
Country [2]
261
0
Australia
Query!
Funding source category [3]
262
0
Commercial sector/Industry
Query!
Name [3]
262
0
Simbex Technologies
Query!
Address [3]
262
0
Query!
Country [3]
262
0
Australia
Query!
Funding source category [4]
263
0
Charities/Societies/Foundations
Query!
Name [4]
263
0
Kidney Health Australia
Query!
Address [4]
263
0
Query!
Country [4]
263
0
Australia
Query!
Primary sponsor type
Charities/Societies/Foundations
Query!
Name
Kidney Health Australia
Query!
Address
Query!
Country
Australia
Query!
Secondary sponsor category [1]
199
0
University
Query!
Name [1]
199
0
University of Sydney
Query!
Address [1]
199
0
Query!
Country [1]
199
0
Australia
Query!
Ethics approval
Ethics application status
Approved
Query!
Ethics committee name [1]
1088
0
SESAHS
Query!
Ethics committee address [1]
1088
0
Query!
Ethics committee country [1]
1088
0
Australia
Query!
Date submitted for ethics approval [1]
1088
0
Query!
Approval date [1]
1088
0
Query!
Ethics approval number [1]
1088
0
Query!
Ethics committee name [2]
1089
0
RPAH
Query!
Ethics committee address [2]
1089
0
Query!
Ethics committee country [2]
1089
0
Australia
Query!
Date submitted for ethics approval [2]
1089
0
Query!
Approval date [2]
1089
0
Query!
Ethics approval number [2]
1089
0
Query!
Ethics committee name [3]
1090
0
USYD
Query!
Ethics committee address [3]
1090
0
Query!
Ethics committee country [3]
1090
0
Australia
Query!
Date submitted for ethics approval [3]
1090
0
Query!
Approval date [3]
1090
0
Query!
Ethics approval number [3]
1090
0
Query!
Summary
Brief summary
This is an RCT to determine the effects of progressive resistance training during hemodialysis in patients with end-stage renal disease
Query!
Trial website
Query!
Trial related presentations / publications
Query!
Public notes
Query!
Contacts
Principal investigator
Name
36383
0
Query!
Address
36383
0
Query!
Country
36383
0
Query!
Phone
36383
0
Query!
Fax
36383
0
Query!
Email
36383
0
Query!
Contact person for public queries
Name
9292
0
Maria Fiatarone Singh
Query!
Address
9292
0
University of Sydney
Cumberland Campus
PO Box 170
Lidcombe NSW 1825
Query!
Country
9292
0
Australia
Query!
Phone
9292
0
+61 2 93519755
Query!
Fax
9292
0
+61 2 93519204
Query!
Email
9292
0
[email protected]
Query!
Contact person for scientific queries
Name
220
0
Maria Fiatarone Singh
Query!
Address
220
0
University of Sydney
Cumberland Campus
East Street
Lidcombe NSW 2141
Query!
Country
220
0
Australia
Query!
Phone
220
0
+61 2 93519755
Query!
Fax
220
0
+61 2 93519204
Query!
Email
220
0
[email protected]
Query!
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.
Download to PDF