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Trial registered on ANZCTR


Registration number
ACTRN12616000121460
Ethics application status
Approved
Date submitted
27/01/2016
Date registered
3/02/2016
Date last updated
25/09/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Blood Flow Restriction Exercise for Muscle Health and Physical Function in End-Stage Kidney Disease
Scientific title
Blood Flow Restriction Exercise for Muscle Health and Physical Function in End-Stage Kidney Disease
Secondary ID [1] 288419 0
None
Universal Trial Number (UTN)
U1111-1178-9379
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
End-Stage Kidney Disease 297435 0
Condition category
Condition code
Renal and Urogenital 297621 297621 0 0
Kidney disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The trial will examine 2 exercise training interventions among patients with end-stage kidney disease. Both exercise training interventions will be completed intradialytically, 3 times per week, for a period of 3 months.

Intervention 1 will examine the use of blood flow restriction to the lower limbs during cycling exercise training (50% reduction in muscle blood flow) using a pneumatic surgical tourniquet. The pneumatic surgical tourniquet includes two cuffs similar to blood pressure cuffs. It auto-regulates the pressure to which the cuffs are inflated based on settings input into the central machine, this pressure adjusts to maintain constant pressure with muscle contraction under the cuff. The cuffs are placed on the most proximal aspect of the thigh. Intervention 1 will involve 10 minutes of cycling, followed by 20 minutes of rest, and then a second 10 minute bout of cycling. The cuffs will only be inflated during the two 10 minute bouts of active cycling, and deflated during the rest. The intensity of the cycling will be based on patients' subjective rating of perceived exertion (RPE) of between 12 and 15 on Borg's 6-20 scale. Blood flow restriction exercise is known to have higher RPEs than equivalent intensity non-blood flow restriction exercise.

Intervention 2 will examine more traditional cycling, without any blood flow restriction, for 20 minutes continuously. This is more reflective of current aerobic training guidelines for end-stage kidney disease patients. The intensity of the cycling will be based on patients' subjective rating of perceived exertion of between 10 and 12 on Borg's 6-20 scale. This would mark the equivalent absolute intensity to that of intervention 1. This is the lower end of what is commonly recommended, and allows for a direct comparison of training adaptations to intervention 1.

All exercise training sessions will be supervised by study staff to ensure that protocol is adhered to, and that all prescribed training intensities are met.
Intervention code [1] 293732 0
Rehabilitation
Intervention code [2] 293733 0
Treatment: Other
Comparator / control treatment
The control group used in this study will be usual care haemodialysis, where patients will undergo their normal dialysis routine, without exercising.
Control group
Active

Outcomes
Primary outcome [1] 297163 0
Knee extensor strength measured by three-repetition maximum bilateral knee extension
Timepoint [1] 297163 0
Baseline within 7 days of commencing intervention, at 3 months, within 7 days of final exercise training session
Secondary outcome [1] 320205 0
Lower limb functional strength reflective of activities of daily living using the 30-second sit-to-stand test
Timepoint [1] 320205 0
Baseline within 7 days of commencing exercise training intervention, and at 3 months, within 7 days of completing the final exercise training session
Secondary outcome [2] 320206 0
Lower limb dynamic balance and mobility using the Timed Up-and-Go test
Timepoint [2] 320206 0
Baseline within 7 days of commencing exercise training intervention, and at 3 months, within 7 days of completing the final exercise training session
Secondary outcome [3] 320207 0
Gait speed, endurance and cardiovascular fitness using the 6-minute walk test
Timepoint [3] 320207 0
Baseline within 7 days of commencing exercise training intervention, and at 3 months, within 7 days of completing the final exercise training session
Secondary outcome [4] 320209 0
Quality of life and physical activity participation using the CHAMPS questionnaire
Timepoint [4] 320209 0
Baseline within 7 days of commencing exercise training intervention, and at 3 months, within 7 days of completing the final exercise training session
Secondary outcome [5] 320300 0
Regional body composition measured using Dual-Energy X-Ray Absorptiometry
Timepoint [5] 320300 0
Baseline within 7 days of commencing exercise training intervention, and at 3 months, within 7 days of completing the final exercise training session
Secondary outcome [6] 339070 0
Thigh musculature sizes measured using peripheral quantitative computer tomography
Timepoint [6] 339070 0
Baseline within 7 days of commencing exercise training intervention, and at 3 months, within 7 days of completing the final exercise training session
Secondary outcome [7] 352255 0
Symptom-related quality of life using the POS-S renal questionnaire
Timepoint [7] 352255 0
Baseline within 7 days of commencing exercise training intervention, and at 3 months, within 7 days of completing the final exercise training session

Eligibility
Key inclusion criteria
Stage V kidney disease (end-stage kidney disease); have been undergoing haemodialysis for more than 3 months;
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
symptomatic peripheral vascular disease; amputation, uncontrolled hypertension, inability to complete requirements of physical testing and exercise training sessions; have been hospitalized for non-dialysis reasons within 4 weeks of study commencement; completing more than 150 minutes per week of moderate to vigorous physical activity including resistance training

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)
Central randomisation by computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Block randomisation using a randomisation table created by 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)
Efficacy
Statistical methods / analysis
Expected effect sizes were originally ascertained based on previous literature utilizing similar aspects of exercise training, and the same primary outcome for knee extensor strength using G-Power 3 statistical software package. Preliminary data was used to update these predictions based on several participants completing the present study. Thus, to achieve a power of 80% at an alpha level of 0.05, 6 participants per group were required to detect a difference between the expected means for percentage strength improvement (the size of the variation in means is represented by a standard deviation of 12.26).

Based on the 3 month duration, a conservative attrition rate of 20% will be adopted, as supported by pilot data for a 12 month training study by our research group (demonstrated attrition of 20% over 12 months). Therefore a total of 21 participants will be recruited for this study.

A mixed model ANOVA for all outcomes comparing baseline to post-intervention data between groups will be used during data analysis.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 9103 0
Box Hill Hospital - Box Hill
Recruitment hospital [2] 9104 0
Peter James Centre - Forest Hill
Recruitment hospital [3] 11992 0
Epworth Eastern Hospital - Box Hill
Recruitment postcode(s) [1] 17603 0
3128 - Box Hill
Recruitment postcode(s) [2] 17604 0
3131 - Forest Hill
Recruitment postcode(s) [3] 24148 0
3128 - Box Hill

Funding & Sponsors
Funding source category [1] 292767 0
University
Name [1] 292767 0
Deakin University
Address [1] 292767 0
221 Burwood Highway, Burwood, VIC 3125
Country [1] 292767 0
Australia
Primary sponsor type
University
Name
Deakin University
Address
221 Burwood Highway, Burwood, VIC 3125
Country
Australia
Secondary sponsor category [1] 291501 0
None
Name [1] 291501 0
none
Address [1] 291501 0
none
Country [1] 291501 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 294258 0
Eastern Health Human Research Ethics Committee
Ethics committee address [1] 294258 0
Level 2
5 Arnold Street
Box Hill VIC 3128
Ethics committee country [1] 294258 0
Australia
Date submitted for ethics approval [1] 294258 0
24/02/2016
Approval date [1] 294258 0
30/06/2016
Ethics approval number [1] 294258 0
E05-2016
Ethics committee name [2] 301540 0
Epworth Healthcare Human Research Ethics Committee
Ethics committee address [2] 301540 0
Epworth Foundation trading as Epworth HealthCare
89 Bridge Rd
Richmond, Victoria, 3121
Ethics committee country [2] 301540 0
Australia
Date submitted for ethics approval [2] 301540 0
20/09/2017
Approval date [2] 301540 0
01/12/2017
Ethics approval number [2] 301540 0
EH2017-265

Summary
Brief summary
People with end stage kidney disease require renal dialysis to maintain health. These people are attached to dialysis machines for 4 hours at least 3 times per week. Both the kidney disease and the dialysis lead to an accelerated physical deterioration, resulting in decreased strength and reduced capacity to perform activities of daily living.

At present, exercise recommendations suggest moderate to high intensity exercise that incorporates both resistance training and aerobic training. To satisfy this requirement it is recommended that 30-60 minutes of exercise training be completed on both dialysis and non-dialysis days. This is very poorly adhered to by patients undergoing dialysis due to decreased exercise capacity, contraindication to high intensities of exercise training, elevated fatigue, and a preference for not doing exercise training on non-dialysis days.

Blood flow restriction (BFR) exercise training elicits significant muscle size and strength increases with low intensities. BFR with aerobic exercise training produces muscle size and strength that is not commonly achieved with non-BFR aerobic exercise training. This has previously been performed in older adult populations, and also with individuals with stable ischaemic heart disease with promising results and can easily be performed during haemodialysis.

This study aims to measure the effect of 3 months of intradialytic BFR exercise training on lower limb strength, muscle size, physical function, and quality of life.

Participants will be recruited from 4 Victorian outpatient and private dialysis units administered by Eastern Health. Participants will be randomly allocated into 3 groups (20 patients in each). The groups will perform one of: BFR aerobic exercise training (BFR AT), non-BFR aerobic exercise training (AT), or non-exercise controls. The BFR AT group will complete 2 bouts of 10 minutes cycling with BFR applied. The AT group will complete 20 minutes of continuous cycling. and the control group will undergo usual-care haemodialysis with no exercise.

It is expected that the BFR AT group will exhibit greater increases in muscle size and strength, as well as greater levels of physical function compared to the AT group following exercise training intervention. Both the BFR AT and AT group will demonstrate greater muscle size and strength than the usual care control group. This study will demonstrate that BFR is a potential alternative to the burdensome exercise recommendations that are, at present, extremely poorly adhered to, or altogether ignored by dialysis patients.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 63074 0
Mr Matthew Clakson
Address 63074 0
Deakin University
School of Exercise and Nutrition Sciences
221 Burwood Highway
Burwood, Victoria
3125
Country 63074 0
Australia
Phone 63074 0
+61 400 225 116
Fax 63074 0
Email 63074 0
mclarks@deakin.edu.au
Contact person for public queries
Name 63075 0
Mr Matthew Clakson
Address 63075 0
Deakin University
School of Exercise and Nutrition Sciences
221 Burwood Highway
Burwood, Victoria
3125
Country 63075 0
Australia
Phone 63075 0
+61 400 225 116
Fax 63075 0
Email 63075 0
mclarks@deakin.edu.au
Contact person for scientific queries
Name 63076 0
Mr Matthew Clakson
Address 63076 0
Deakin University
School of Exercise and Nutrition Sciences
221 Burwood Highway
Burwood, Victoria
3125
Country 63076 0
Australia
Phone 63076 0
+61 400 225 116
Fax 63076 0
Email 63076 0
mclarks@deakin.edu.au

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