Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12608000247370
Ethics application status
Approved
Date submitted
9/05/2008
Date registered
14/05/2008
Date last updated
3/07/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
Effects of Exercise Training on Arterial Stiffness in Haemodialysis Patients
Scientific title
Effects of aerobic exercise training on arterial stiffness in end-stage renal disease patients on maintenance haemodialysis
Universal Trial Number (UTN)
Trial acronym
PEDAL Study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
End-stage renal disease 3127 0
Arterial stiffness 3128 0
Physical function 3129 0
Self-reported health 3130 0
Condition category
Condition code
Cardiovascular 3290 3290 0 0
Coronary heart disease
Renal and Urogenital 3291 3291 0 0
Kidney disease
Musculoskeletal 3292 3292 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
6 months Intradialytic exercise training (3 times per week for up to 45mins) on leg-cycle Monark Rehab Trainer 881 at Borg's (6-20) rating of perceived exertion scale of 12-13.
6months outside-dialysis walking program (3 times per week for up to 45 minutes) at Borg's (6-20) rating of perceived exertion scale of 12-13.
Intervention code [1] 2872 0
Lifestyle
Comparator / control treatment
The control is 6 months usual care of haemodialysis treatment with no exercise training
Control group
Active

Outcomes
Primary outcome [1] 4179 0
Arterial stiffness measured by augmentation and pulsewave velocity
Timepoint [1] 4179 0
Baseline, 3- and 6- months after commencement of intervention
Secondary outcome [1] 7064 0
Self-reported health and physical activity levels using the SF-36 survey and Active Australia Questionnaire respectively
Timepoint [1] 7064 0
Baseline, 3- and 6 months after commencement of intervention
Secondary outcome [2] 7065 0
Physical function as measured by 6-minute walk test, hand grip strength, and timed-get up and go test
Timepoint [2] 7065 0
Baseline, 3- and 6- months after commencement of intervention

Eligibility
Key inclusion criteria
Currently on maintenance haemodialysis treatment
Minimum age
18 Years
Maximum age
85 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Individuals with known unstable angina, or lower limb(s) amputation, or already participate in high amounts of physical activity

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Participants from renal units are approached to participate in the study. A full informed consent process of four weeks was performed before subjects give written consent to participate in the study. The person consenting the patient is not aware of the group the patient will be allocated to. The allocation is performed off-site by a third party using a randomly generated sequence created by a computer software.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomly generated sequence created by a computer software
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/05/2006
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
45
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 837 0
7250
Recruitment postcode(s) [2] 838 0
7000
Recruitment postcode(s) [3] 839 0
7000

Funding & Sponsors
Funding source category [1] 3367 0
Hospital
Name [1] 3367 0
Renal Research Tasmania
Country [1] 3367 0
Australia
Primary sponsor type
Hospital
Name
Launceston General Hospital
Address
Charles St Launceston Tasmania 7250
Country
Australia
Secondary sponsor category [1] 3014 0
University
Name [1] 3014 0
University of Tasmania
Address [1] 3014 0
School of Human Life Sciences,
Newham Tasmania
Country [1] 3014 0
Australia
Other collaborator category [1] 281 0
University
Name [1] 281 0
University of Queensland
Address [1] 281 0
School of Human Movement Studies St. Lucia Queensland
Country [1] 281 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 5392 0
Human Research Ethics Committee (Tasmania) Network
Ethics committee address [1] 5392 0
Private Bag 01 Hobart Tasmania 7001
Ethics committee country [1] 5392 0
Australia
Date submitted for ethics approval [1] 5392 0
Approval date [1] 5392 0
17/12/2004
Ethics approval number [1] 5392 0
H 8124

Summary
Brief summary
Trial website
Trial related presentations / publications
ACSM (New Orleans, Apr 2007) - Poster
Comparison of supervised exercise training and non-supervised exercise training on
arterial stiffness, physical function and self-reported quality of life.
ACSMS (Adelaide, 13-16 Oct 2007) - Podium
Comparison of supervised exercise training and non-supervised exercise training on
arterial stiffness, physical function and self-reported quality of life.
APCESS (Hiroshima, 6-8 Dec 2007) - Poster
Comparison of supervised exercise training and non-supervised exercise training on
arterial stiffness, physical function and self-reported quality of life.
Medical Research Week (Launceston General Hospital, Sep 2006) - Oral
The Effects of Exercise Training on Arterial Stiffness, Physical Function and Quality
of Life in Haemodialysis Patients: The PEDAL Study.
AAESS Conference (Mar 2008)-oral
Effects of Exercise Training on Arterial Stiffness, Physical Function and Self-reported Health in Haemodialysis Patients
Public notes

Contacts
Principal investigator
Name 28578 0
Address 28578 0
Country 28578 0
Phone 28578 0
Fax 28578 0
Email 28578 0
Contact person for public queries
Name 11735 0
Prof Rob Fassett
Address 11735 0
Launceston General Hospital
Charles Street
Launceston
Tasmania 7250
Country 11735 0
Australia
Phone 11735 0
03 6348 7111
Fax 11735 0
03 6348 7090
Email 11735 0
rob.fassett@dhhs.tas.gov.au
Contact person for scientific queries
Name 2663 0
Assoc Prof Jeff Coombes
Address 2663 0
University of Queensland
School of Human Movement Studies
St Lucia
Queensland
Country 2663 0
Australia
Phone 2663 0
07 3365 6767
Fax 2663 0
07 3365 6877
Email 2663 0
jcoomes@hms.uq.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.