Trial Review

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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
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
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
End stage renal disease 182 0
Condition category
Condition code
Renal and Urogenital 206 206 0 0
Other renal and urogenital disorders
Musculoskeletal 207 207 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The experimental grroup will receive progressive Resistance Training for 24 weeks in addition to usual care.
Intervention code [1] 103 0
Treatment: Other
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.
Control group
Active

Outcomes
Primary outcome [1] 246 0
Skeletal muscle cross-sectional area and attenuation
Timepoint [1] 246 0
Measured at baseline, week 12 and week 24
Secondary outcome [1] 553 0
6-minute walk
Timepoint [1] 553 0
Measured at baseline, week 12 and week 24.
Secondary outcome [2] 554 0
Isometric muscular strength
Timepoint [2] 554 0
Measured at baseline, week 12 and week 24.
Secondary outcome [3] 555 0
Static balance
Timepoint [3] 555 0
Measured at baseline, week 12 and week 24.
Secondary outcome [4] 556 0
Geriatric Depression Scale (GDS)
Timepoint [4] 556 0
Measured at baseline, week 12 and week 24.
Secondary outcome [5] 557 0
Quality of Life (SF-36)
Timepoint [5] 557 0
Measured at baseline, week 12 and week 24.
Secondary outcome [6] 558 0
Physical Activity Scale for the Elderly (PASE)
Timepoint [6] 558 0
Measured at baseline, week 12 and week 24.
Secondary outcome [7] 559 0
Haemotological markers
Timepoint [7] 559 0
Measured at baseline, week 12 and week 24.
Secondary outcome [8] 560 0
C-reactive protein
Timepoint [8] 560 0
Measured at baseline, week 12 and week 24.
Secondary outcome [9] 561 0
Dialysis Adequacy (Kt/V)
Timepoint [9] 561 0
Measured at baseline, week 12 and week 24.
Secondary outcome [10] 562 0
Mini-nutritional assessment (MNA),
Timepoint [10] 562 0
Measured at baseline, week 12 and week 24.
Secondary outcome [11] 563 0
Protein Catabolic Rate
Timepoint [11] 563 0
Measured at baseline, week 12 and week 24.
Secondary outcome [12] 564 0
Dietary Intake (Australian Food Frequency Questionnaire).
Timepoint [12] 564 0
Measured at baseline, week 12 and week 24.

Eligibility
Key inclusion criteria
Stable hemodialysis patients with no contraindications to progressive resistance training.
Minimum age
Not stated
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
No exclusion criteria

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
concealed opaque envelope. Assignment following baseline testing.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
computer-generated randomization list
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
RCT
Phase
Phase 1
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
1/10/2002
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
50
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 260 0
Government body
Name [1] 260 0
NHMRC
Country [1] 260 0
Australia
Funding source category [2] 261 0
University
Name [2] 261 0
University of Sydney
Country [2] 261 0
Australia
Funding source category [3] 262 0
Commercial sector/Industry
Name [3] 262 0
Simbex Technologies
Country [3] 262 0
Australia
Funding source category [4] 263 0
Charities/Societies/Foundations
Name [4] 263 0
Kidney Health Australia
Country [4] 263 0
Australia
Primary sponsor type
Charities/Societies/Foundations
Name
Kidney Health Australia
Address
Country
Australia
Secondary sponsor category [1] 199 0
University
Name [1] 199 0
University of Sydney
Address [1] 199 0
Country [1] 199 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 1088 0
SESAHS
Ethics committee address [1] 1088 0
Ethics committee country [1] 1088 0
Australia
Date submitted for ethics approval [1] 1088 0
Approval date [1] 1088 0
Ethics approval number [1] 1088 0
Ethics committee name [2] 1089 0
RPAH
Ethics committee address [2] 1089 0
Ethics committee country [2] 1089 0
Australia
Date submitted for ethics approval [2] 1089 0
Approval date [2] 1089 0
Ethics approval number [2] 1089 0
Ethics committee name [3] 1090 0
USYD
Ethics committee address [3] 1090 0
Ethics committee country [3] 1090 0
Australia
Date submitted for ethics approval [3] 1090 0
Approval date [3] 1090 0
Ethics approval number [3] 1090 0

Summary
Brief summary
This is an RCT to determine the effects of progressive resistance training during hemodialysis in patients with end-stage renal disease
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 36383 0
Address 36383 0
Country 36383 0
Phone 36383 0
Fax 36383 0
Email 36383 0
Contact person for public queries
Name 9292 0
Maria Fiatarone Singh
Address 9292 0
University of Sydney
Cumberland Campus
PO Box 170
Lidcombe NSW 1825
Country 9292 0
Australia
Phone 9292 0
+61 2 93519755
Fax 9292 0
+61 2 93519204
Email 9292 0
m.singh@fhs.usyd.edu.au
Contact person for scientific queries
Name 220 0
Maria Fiatarone Singh
Address 220 0
University of Sydney
Cumberland Campus
East Street
Lidcombe NSW 2141
Country 220 0
Australia
Phone 220 0
+61 2 93519755
Fax 220 0
+61 2 93519204
Email 220 0
m.singh@fhs.usyd.edu.au

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.