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Trial registered on ANZCTR

Registration number
Ethics application status
Date submitted
Date registered
Date last updated
Type of registration
Prospectively registered

Titles & IDs
Public title
Exercise Physiologists in Renal Dialysis
Scientific title
The effect of a lower body resistance exercise program, administered by accredited exercise physiologists, on the physical function of adults receiving 3 weekly haemodialysis
Secondary ID [1] 281556 0
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic Kidney Disease 287832 0
Condition category
Condition code
Renal and Urogenital 288179 288179 0 0
Kidney disease
Physical Medicine / Rehabilitation 288191 288191 0 0
Other physical medicine / rehabilitation

Study type
Description of intervention(s) / exposure
Resistance Exercises: Leg abduction, plantar flexion, dorsi flexion, straight-leg/bent-knee raise, knee extension and knee flexion. All resistance exercises will be done in a seated position while still receiving dialysis treatment. The exercises will be done during the first hour of dialysis treatment. When participants are able to perform two sets of 15-20 repetitions for each exercise, the resistance exercises will be made progressively harder using different colour-graded elastic bands and tubings. Participants will also be encouraged to perform each exercise (lifting phase - concentric contraction) as rapidly as possible to optimise movement speed and muscle power. The sessions will last between 30 and 60 minutes and performed 3 times a week to coincide with patients' existing dialysis treatment schedule. The stepwedged design will provide the intervention for 3, 6 or 9 months depending on the randomly allocated group. This will mean that all groups will receive at least 3 months of the intrevention.
Intervention code [1] 286072 0
Comparator / control treatment
Standard Care. The standard care comparitor will consist of no, or minimal, exercises on dialysis. Exercises are rarely performed on dialysis as standard care but if they are the exercises will be up to the participant themselves. Given that they will be performed on dialysis they will be supervised by nursing staff.
Control group

Primary outcome [1] 288378 0
Objective Physical Function: This will be measured by the 30-second sit to stand test
Timepoint [1] 288378 0
12 months
Secondary outcome [1] 300008 0
Quality of life. This will be measured at all 5 time points using the Kidney Dialysis Quality of Life Index (KDQOL).
Timepoint [1] 300008 0
12 months

Key inclusion criteria
People with end stage renal disease
Receiving haemodialysis greater than three months
Able to understand spoken English
Minimum age
18 Years
Maximum age
No limit
Both males and females
Can healthy volunteers participate?
Key exclusion criteria
Previous lower limb amputation
Hospitalised in the month prior to study commencement

Study design
Purpose of the study
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Cluster randomised controlled trial.
Unit cluster consists of one dialysis unit. A total of 15 units will be randomised into one of three groups.
Allocation will be concealed.
Central randomisation via excel spreadsheet.
Research assistant not external to the study will undertake randomisation.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation via excel spreadsheet.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?

Intervention assignment
Other design features
Stepwedged trial. In this study Group 1 (5 clinics, n=60) receive 9 months of exercise intervention, Group 2 (5 clinics, n=60) will receive 6 months and Group 3 (5 clinics, n=60) receive 3 months. Baseline data will be collected 3 months prior to the commencement of the intervention (Time 1). Group 1 will commence exercise intervention at Time 2 (3 months), Group 2 at will commence at Time 3 (6 months) and Group 3 will commence at Time 4 (9 months). Data will be collected for all participants at each time point, with the final data collected 3 months after Group 3 commences the exercise intervention (i.e., Time 5, 12 months).
Not Applicable
Type of endpoint(s)
Statistical methods / analysis

Recruitment status
Date of first participant enrolment
Date of last participant enrolment
Date of last data collection
Sample size
Accrual to date
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 286341 0
Name [1] 286341 0
Deakin University
Address [1] 286341 0
221 Burwood Rd, Burwood, Victoria, 3125
Country [1] 286341 0
Primary sponsor type
Associate Professor Paul Bennett
School of Nursing and Midwifery
221 Burwood Highway Burwood Victoria 3125
Secondary sponsor category [1] 285133 0
Name [1] 285133 0
Professor Robin Daly
Address [1] 285133 0
School of Exercise and Nutrition Sciences
Deakin University
221 Burwood Highway, Burwood Victoria 3125
Country [1] 285133 0

Ethics approval
Ethics application status
Ethics committee name [1] 288419 0
Southern Health HREC
Ethics committee address [1] 288419 0
Monash Medical Centre
Clayton Road, Clayton, Victoria, 3168
Ethics committee country [1] 288419 0
Date submitted for ethics approval [1] 288419 0
Approval date [1] 288419 0
Ethics approval number [1] 288419 0

Brief summary
This study will measure the direct impact of an exercise program on the health outcomes of people with chronic kidney disease on dialysis. The health outcomes that will be measured include: physical function, quality of life, uptake of community exercise programs, self-reported falls, and biochemical markers. This work is significant given the effects of end stage kidney disease on musculoskeletal health in this group. There is a current absence of exercise programs in haemodialysis clinics globally, leading to a decline in dialysis patients’ physical function and increased costs to health services.
Study Hypothesis: Accredited exercise physiologists providing a resistance exercise program will improve the physical function of people with chronic kidney disease receiving haemodialysis.
Trial website
Trial related presentations / publications
Bennett, PN, Fraser, S, Barnard, R. Haines, T. Ockerby, C., Street, M., Wang, W. & Daly, R. (2016) Effects of an intradialytic resistance training programme on physical function: a prospective stepped-wedge randomized controlled trial Nephrol. Dial. Transplant. 31(8) 1302-9
Public notes

Principal investigator
Name 34963 0
Prof Paul Bennett
Address 34963 0
Deakin University, 221 Burwood Hwy Burwood, 3125, VIC
Country 34963 0
Phone 34963 0
Fax 34963 0
Email 34963 0
Contact person for public queries
Name 18210 0
Prof Associate Professor Paul Bennett
Address 18210 0
School of Nursing and Midwifery
221 Burwood Highway, Burwood, Victoria, 3125
Country 18210 0
Phone 18210 0
+61 8 92517847
Fax 18210 0
Email 18210 0
Contact person for scientific queries
Name 9138 0
Prof Associate Professor Paul Bennett
Address 9138 0
School of Nursing and Midwifery
221 Burwood Highway, Burwood, Victoria, 3125
Country 9138 0
Phone 9138 0
+61 8 92517847
Fax 9138 0
Email 9138 0

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary