None listed
Conditions
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.
Interventions
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
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.
Sponsors
Deakin University
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Stage V kidney disease (end-stage kidney disease); have been undergoing haemodialysis for more than 3 months;
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
Outcome results
None listed