Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000987268
Ethics application status
Not yet submitted
Date submitted
13/11/2009
Date registered
17/11/2009
Date last updated
17/11/2009
Type of registration
Prospectively registered

Titles & IDs
Public title
The effect of intra-dialytic exercise training on pro-inflammatory cytokines, endothelial function and functional capacity in chronic kidney disease patients.
Scientific title
The effect of intra-dialytic exercise training versus usual care on functional capacity, systematic inflammation, quality of life, blood vessel function and biochemistry in patients with chronic kidney disease.
Secondary ID [1] 1137 0
None
Universal Trial Number (UTN)
U1111-1112-5020
Trial acronym
None
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic Kidney Disease 252200 0
Condition category
Condition code
Renal and Urogenital 252395 252395 0 0
Kidney disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Exercise training (cycling) for 45 minutes, 3 times per week for 3 months at about 65% maximum.
Intervention code [1] 241552 0
Rehabilitation
Comparator / control treatment
Usual Care is dialysis 3 sessions per week for approxiamtely 4 hours per session and nephrology consultations as required.
Control group
Active

Outcomes
Primary outcome [1] 253269 0
Peak Volume of oxygen (VO2) measured by incremental, maximal exercise test conducted on a cycle ergometer.
Timepoint [1] 253269 0
0, 3, 6 months following randomization
Primary outcome [2] 253270 0
Quality of life. This measurement will be made using the Kidney Disease Quality of Life (KDQOL) questionnaire.
Timepoint [2] 253270 0
0, 3, 6 months following randomization
Primary outcome [3] 253271 0
Systemic Inflammation interleukin -1(IL-1), interleukin-6 (IL-6), interleukin-10 (IL-10), tumour necrosis factor alpha (TNF-alpha) and TNF-alpha soluble receptors I and II will be measured by immunoassay.
Timepoint [3] 253271 0
0, 3, 6 months following randomization
Primary outcome [4] 253272 0
Blood vessel function by Doppler ultrasound
Timepoint [4] 253272 0
0, 3, 6 months following randomization
Secondary outcome [1] 262268 0
Nil
Timepoint [1] 262268 0
Nil

Eligibility
Key inclusion criteria
Chronic kidney disease
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Paediatric
Inability to exercise

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)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer generated random numbers
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Nil
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/01/2010
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
54
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 2216 0
4215

Funding & Sponsors
Funding source category [1] 244017 0
University
Name [1] 244017 0
Bond University
Country [1] 244017 0
Australia
Primary sponsor type
University
Name
Bond University
Address
Robina
QLD 4229
Country
Australia
Secondary sponsor category [1] 251368 0
None
Name [1] 251368 0
Address [1] 251368 0
Country [1] 251368 0
Other collaborator category [1] 957 0
Hospital
Name [1] 957 0
Gold Coast Hospital
Address [1] 957 0
108 Nerang-Southport Road, Southport
QLD 4215
Country [1] 957 0
Australia

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 258125 0
Bond University Human Research Ethics Committe
Ethics committee address [1] 258125 0
Bond University
Robina
QLD 4229
Ethics committee country [1] 258125 0
Australia
Date submitted for ethics approval [1] 258125 0
30/11/2009
Approval date [1] 258125 0
Ethics approval number [1] 258125 0
EC00357
Ethics committee name [2] 258126 0
Gold Coast District Health Service
Ethics committee address [2] 258126 0
108 Southport-Nerang Road, Southport
QLD 4215
Ethics committee country [2] 258126 0
Australia
Date submitted for ethics approval [2] 258126 0
30/11/2009
Approval date [2] 258126 0
Ethics approval number [2] 258126 0
EC00160

Summary
Brief summary
Most dialysis patients are susceptible to cardiovascular disease (CVD) because of inflammation due to the kidney disease and dialysis. Regular exercise training has been shown to reduce inflammation in healthy people and people with CVD, but as yet it is not known whether exercise can help reduce inflammation in people undertaking dialysis.
Trial website
Nil
Trial related presentations / publications
Nil
Public notes

Contacts
Principal investigator
Name 30511 0
Address 30511 0
Country 30511 0
Phone 30511 0
Fax 30511 0
Email 30511 0
Contact person for public queries
Name 13758 0
Neil Smart
Address 13758 0
Faculty Health Science and Medicine (HSM)
Bond University
Robina QLD 4229
Country 13758 0
Australia
Phone 13758 0
+61 7 55954453
Fax 13758 0
+61 7 5595 4122
Email 13758 0
nsmart@bond.edu.au
Contact person for scientific queries
Name 4686 0
Neil Smart
Address 4686 0
Faculty HSM
Bond University
Robina QLD 4229
Country 4686 0
Australia
Phone 4686 0
+ 61 7 55954453
Fax 4686 0
+61 7 55954122
Email 4686 0
nsmart@bond.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.