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
试验速览
- 阶段
- 2 期
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Brachial artery flow mediated dilatation
研究概览
简要总结
The aim of this study is to evaluate whether a three month intra-dialytic exercise programme improves arterial function.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Stage 5 CKD patients (GFR <15 mL/min) receiving maintenance haemodialysis therapy
- •Male or female
- •Aged >18 years
- •Written informed consent
排除标准
- •Pregnancy
- •Unstable cardiovascular conditions
- •Recent cerebrovascular event
- •Excess inter-dialytic weight gain
- •Use of corticosteroids, anabolic therapies,
- •Co-morbid catabolic conditions
- •Serum potassium regularly >6mmol/L
- •Recent pulmonary thromboembolism
- •Psychiatric illness including anxiety, mood and untreated eating disorders
- •Infection or course of antibiotics within one month of study period.
- •Dementia or severe cognitive impairment.
研究组 & 干预措施
Progressive muscle relaxation
As well as usual care participants in the control arm will receive instruction in progressive muscle relaxation.
干预措施: Progressive Muscle relaxation (Other)
Aerobic exercise
Intervention -moderate intensity aerobic exercise.
干预措施: Intradialytic aerobic exercise (Other)
结局指标
主要结局
Brachial artery flow mediated dilatation
时间窗: Baseline and 12 week follow-up
Brachial artery diameter is measured using vascular ultrasound. A cuff similar to that used for blood pressure is then inflated around the forearm for 5 minutes. Following cuff release vascular ultrasound is used to measure arterial dilation in response to reactive hyperaemia. Relative change in diameter provides a measure of endothelial function. Images are recorded over a period of 4-5 minutes post cuff release.
次要结局
- Aortic pulse wave velocity(Baseline and three month follow-up)
- Maximal aerobic power(Baseline and three months)
- Timed up-and-go(Baseline and three month follow-up)
- Sit-to-stand 5(Baseline and 3 month follow-up)
- Non exercise questionnaire(Baseline and 3 month follow-up)
- Physical activity(Baseline and 3 month follow-up)
- Kidney Disease Quality of Life Short Form (KDQOL)(Baseline and 3 month follow-up)
- Duke Activity Status Index(Baseline and 3 months)
- Leicester Uraemic Symptom Scale (LUSS)(Baseline and 3 month follow-up)
研究者
Sean Prescott
PhD Research Student
Queen Margaret University