NCT01591876

Exercise and Vascular Function in Haemodialysis Patients

The Effect of an Intra-dialytic Aerobic Exercise Intervention on Vascular Function in People Undergoing Maintenance Haemodialysis Therapy for Chronic Kidney Disease Stage 5. An Exploratory Study

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Queen Margaret University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The aim of this study is to evaluate whether a three month intra-dialytic exercise programme improves arterial function.

Detailed description

Life expectancies in haemodialysis patients are significantly shorter than the general population due to higher cardiovascular disease risk. This is mediated by higher prevalence of cardiovascular risk factors associated with chronic kidney disease and the haemodialysis procedure. Consequently ageing of the arterial system is accelerated in this condition leading to higher prevalence of arterial plaques and increased arterial stiffness. Higher physical activity and fitness are associated with lower cardiovascular disease and all-cause mortality in haemodialysis patients and the general population. Moreover, physical inactivity is associated with increased arterial stiffness and plaques which narrow heart arteries. Worryingly the haemodialysis population is on average highly inactive with low fitness. Current research demonstrates that exercise which improves fitness improves arterial health. Increased bloodflow during exercise stimulates the release of nitric oxide causing arteries to dilate. Regular exercise is believed to lead to beneficial remodelling of arteries and lower arterial stiffness. Exercise is reported to improve arterial function across a range of conditions. However published research regarding the possible benefits of long term aerobic exercise on arterial health in this population is conflicting. Limitations in study design, moderately high participant dropout rates and low statistical power hamper a definitive conclusion. Importantly a gold standard measure of arterial function has not been used in previously published studies. There is ample evidence that exercise programmes in people on dialysis improve fitness, physical function, and quality of life. It is also clear that a state of higher physical activity and fitness is associated with better arterial function in the general population. It would be advantageous for reasons of health counselling to determine whether the process of improving physical fitness and activity levels may also improve arterial health in haemodialysis patients.

Conditions

• Chronic Kidney Disease Stage 5

Interventions

Type	Name	Description
OTHER	Intradialytic aerobic exercise	Participants in the intervention group will undertake moderate intensity aerobic exercise. Exercise modality will be recumbent cycling during the first two hours of haemodialysis sessions. Exercise prescription is set using a graded exercise test and anchored to a perceived level of exertion using the BORG scale. Training stimulus is maintained by the participant by increasing the cycling resistance when perceived exertion drops by one point at the current resistance level. Adherence and training volume is recorded during the intervention period.
OTHER	Progressive Muscle relaxation	This is a sequence of stretching and relaxation of the major muscle groups of the body. Participants are initially given detailed information regarding the technique and then provided with a recorded version which they listen to for 30-40 minutes during dialysis sessions. Participants in this group are offered the exercise programme at the end of three months.

Timeline

• Start date: 2012-11-01
• Primary completion: 2013-07-01
• Completion: 2014-02-01
• First posted: 2012-05-04
• Last updated: 2013-03-01

Locations

1 site across 1 country: United Kingdom