Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612001223820
Ethics application status
Approved
Date submitted
17/11/2012
Date registered
19/11/2012
Date last updated
26/07/2018
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
Nil
Universal Trial Number (UTN)
Trial acronym
ExPiReD
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

Intervention/exposure
Study type
Interventional
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
Rehabilitation
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
Active

Outcomes
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

Eligibility
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
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Previous lower limb amputation
Hospitalised in the month prior to study commencement

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)
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
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).
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/05/2013
Actual
1/05/2013
Date of last participant enrolment
Anticipated
Actual
1/01/2014
Date of last data collection
Anticipated
Actual
1/06/2014
Sample size
Target
171
Accrual to date
Final
177
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 286341 0
University
Name [1] 286341 0
Deakin University
Country [1] 286341 0
Australia
Primary sponsor type
Individual
Name
Associate Professor Paul Bennett
Address
School of Nursing and Midwifery
221 Burwood Highway Burwood Victoria 3125
Country
Australia
Secondary sponsor category [1] 285133 0
Individual
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
Australia

Ethics approval
Ethics application status
Approved
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
Australia
Date submitted for ethics approval [1] 288419 0
29/11/2012
Approval date [1] 288419 0
23/01/2013
Ethics approval number [1] 288419 0
12376B

Summary
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

Contacts
Principal investigator
Name 34963 0
Prof Paul Bennett
Address 34963 0
Deakin University, 221 Burwood Hwy Burwood, 3125, VIC
Country 34963 0
Australia
Phone 34963 0
+61438803809
Fax 34963 0
Email 34963 0
[email protected]
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
Australia
Phone 18210 0
+61 8 92517847
Fax 18210 0
Email 18210 0
[email protected]
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
Australia
Phone 9138 0
+61 8 92517847
Fax 9138 0
Email 9138 0
[email protected]

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
SourceTitleYear of PublicationDOI
EmbaseEffects of an intradialytic resistance training programme on physical function: A prospective stepped-wedge randomized controlled trial.2016https://dx.doi.org/10.1093/ndt/gfv416
N.B. These documents automatically identified may not have been verified by the study sponsor.