Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12606000158561
Ethics application status
Not yet submitted
Date submitted
3/05/2006
Date registered
4/05/2006
Date last updated
4/05/2006
Type of registration
Prospectively registered

Titles & IDs
Public title
Impact of regular exercise during haemodialysis on arterial stiffness
Scientific title
Improvement of arterial compliance with regular exercise during haemodialysis
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cardiovascular disease and arterial stiffness in haemodialysis patients 1131 0
Condition category
Condition code
Cardiovascular 1209 1209 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The implementation of regular exercise during haemodialysis sessions. Regular exercise will be in the form of pedal bicycle ergometry, one hour on dialysis, 3 times weekly for 3 months. Cross-over will occur at 3 months with a one week wash-out period in between the exercise and no exercise arms.
Intervention code [1] 1015 0
Lifestyle
Comparator / control treatment
No exercise
Control group
Active

Outcomes
Primary outcome [1] 1640 0
Improvement in arterial compliance
Timepoint [1] 1640 0
After 3 months of exercise
Secondary outcome [1] 2937 0
Changes in serum parameters of anaemia and mineral metabolism.
Timepoint [1] 2937 0
After 3 months of exercise.

Eligibility
Key inclusion criteria
Adult conventional haemodialysis patients (3-5hrs, 3x weekly).
Minimum age
18 Years
Maximum age
85 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Active respiratory disease or ischaemic heart disease, unable to execise with a pedal bicycle ergometer, unable to give infomed consent.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/06/2006
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 1322 0
Hospital
Name [1] 1322 0
Department of Nephrology, Monash Medical Centre
Country [1] 1322 0
Australia
Primary sponsor type
Individual
Name
Dr Nigel Toussaint, Department of Nephrology, Monash Medical Centre
Address
Country
Australia
Secondary sponsor category [1] 1167 0
None
Name [1] 1167 0
Nil
Address [1] 1167 0
Country [1] 1167 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 2648 0
Southern Health Ethics Committee-Monash Medical Centre
Ethics committee address [1] 2648 0
Clayton, Victoria
Ethics committee country [1] 2648 0
Australia
Date submitted for ethics approval [1] 2648 0
Approval date [1] 2648 0
Ethics approval number [1] 2648 0

Summary
Brief summary
Assessing the impact of exercise (one hour, 3 times weekly on dialysis) using a bicycle ergometer for 3 months, on arterial stiffness (and therefore cardiovascular health) in patients on haemodialysis. Using pulse wave velocity (non invasive applanation tonometry) to measure the changes in degree of arterial siffness
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 35821 0
Address 35821 0
Country 35821 0
Phone 35821 0
Fax 35821 0
Email 35821 0
Contact person for public queries
Name 10204 0
Dr Nigel Toussaint
Address 10204 0
Department of Nephrology
Monash Medical Centre
246 Clayton Rd
Clayton VIC 3168
Country 10204 0
Australia
Phone 10204 0
+61 3 95943533
Fax 10204 0
Email 10204 0
nigel.toussaint@med.monash.edu.au
Contact person for scientific queries
Name 1132 0
Dr Nigel Toussaint
Address 1132 0
Department of Nephrology
Monash Medical Centre
246 Clayton Rd
Clayton VIC 3168
Country 1132 0
Australia
Phone 1132 0
+61 3 95943533
Fax 1132 0
Email 1132 0
nigel.toussaint@med.monash.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.