ANZCTR - Registration

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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]

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

Condition category

Condition code

Renal and Urogenital

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]

Rehabilitation

Intervention code [2]

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]

Knee extensor strength measured by three-repetition maximum bilateral knee extension

Timepoint [1]

Baseline within 7 days of commencing intervention, at 3 months, within 7 days of final exercise training session

Secondary outcome [1]

Lower limb functional strength reflective of activities of daily living using the 30-second sit-to-stand test

Timepoint [1]