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临床试验/NCT01481688
NCT01481688Unknown4 期

Intradialytic Exercise for Enhanced Dialysis Adequacy and Solute Removal in Chronic Kidney Disease Patients: A Randomised Controlled Trial.

Bangor University2 个研究点 分布在 1 个国家目标入组 14 人开始时间: 2011年11月最近更新:
适应症

试验速览

阶段
4 期
入组人数
14
试验地点
2
主要终点
Urea clearance

研究概览

简要总结

The purpose of this study is to investigate whether intradialytic exercise increases removal of waste products from blood, in comparison to the traditional prescription of increasing dialysis duration.

详细描述

For patients with severe chronic kidney disease, regular dialysis to remove toxins and waste products from the blood is essential to maintain life. The adequacy of dialysis is quantified by the removal of these toxic solutes and is an important parameter in the assessment of the therapy.

Previous efforts to enhance urea clearance have centered around factors such as increasing dialysis dose by increasing dialysis time or carrying out more frequent dialysis sessions. However this concept is confronted with the barriers of patient compliance and cost implications. Many patients are resilient to increasing their dialysis time, presenting a major challenge for enhancing the efficacy of dialysis therapy. Therefore, alternative methods of improving dialysis adequacy, with interventions aimed at enhancing solute clearance, are highly warranted.

One such intervention could be exercising during haemodialysis (HD). 85% of the body is comprised of lean tissue, of which 73% is water. As many toxic solutes are water based, large amounts will be stored in the muscle. When sitting at rest during HD the blood flow to the muscles is four times less compared to the major organs. Additionally, the HD process causes blood vessels to constrict, further restricting blood flow to the muscle. Consequently there is insufficient blood flow to remove the toxins stored in the muscle. By exercising during dialysis, blood flow to the muscle is increased to sustain the demand for oxygen and energy, thereby allowing toxic solutes to be removed and cleared through the dialysis machine.

Therefore the aim of this study is to implement an efficient exercise intervention during dialysis and determine its effects on dialysis adequacy in comparison to the traditional prescription of increased dialysis time. In particular, the study aims to explore the acute effects of exercise during dialysis on the removal of several established uremic toxins.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Stage 5 Chronic Kidney Disease
  • Receiving maintenance haemodialysis for > 3 months

排除标准

  • Unable to give consent
  • Present with contraindications to take part in exercise
  • Haemoglobin <11 g/dL
  • Access recirculation
  • Chronic persistent hypotension with pre dialysis systolic blood pressures <100mgHg.
  • Episodic treatment induced hypotension with frequent drops in intradialytic systolic blood pressure >30mmgHg
  • Unstable medical condition
  • Currently taking medication affecting urea or creatinine generation

结局指标

主要结局

Urea clearance

时间窗: One dialysis session

The primary outcome is urea clearance which will be measured by continuously sampling waste dialysate from an entire dialysis session.

次要结局

  • Urea clearance(One dialysis session)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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