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Acute Physiological Response to Exercise in End Stage Renal Disease (PRECISE)

2020年2月19日 更新者:Mr Scott McGuire、Coventry University
Chronic kidney disease (CKD) affects between 5-10% of the world's population, equating to ~740 million people worldwide. End stage renal disease (ESRD) is the result of a progressive loss of kidney function where the patient requires dialysis to replace the typical functions of the kidney. The quality of life of these individuals can be poor as a result of various complications associated with CKD (e.g. heart disease, diabetes, muscle wastage, decreased fitness). In an attempt to combat reduced physical fitness, many studies have applied long term exercise programmes. However, the body's response to exercise in people with CKD is not well understood and a set of guidelines that informs safe and effective exercise prescription is lacking.

研究概览

地位

完全的

条件

详细说明

Chronic kidney disease (CKD) affects between 5-10% of the world's population, equating to ~740 million people worldwide. End stage renal disease (ESRD) is the result of a progressive loss of kidney function where the patient requires dialysis to replace the typical functions of the kidney. The quality of life (QOL) of these individuals is severely impaired as a result of various complications associated with CKD (e.g. heart disease, diabetes, muscle wastage, decreased fitness). In an attempt to combat this decrease in physical fitness, many studies have applied long term exercise interventions. However, the acute response to exercise in this population is not entirely understood and a comprehensive set of guidelines that informs safe and effective exercise prescription is lacking.

The use of exercise as a therapeutic intervention in ESRD has grown in popularity, and evidence provided by numerous long term studies indicates cardiopulmonary, metabolic and inflammatory system adaptations. Despite these positive findings, the specific mechanisms through which exercise benefits these patients have not yet been fully established. In addition, the extent to which 'normal' physiology is acutely altered by dialysis treatment, and the effect that aerobic exercise may have on this, is unknown.

In patients with ESRD, this study aims to characterise the acute physiological response to exercise under different conditions. In doing so, the study aims to inform the development of guidelines for safe and effective intra-dialytic exercise training.

研究类型

观察性的

注册 (实际的)

40

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

    • Warwickshire
      • Coventry、Warwickshire、英国、CV1 3LN
        • UHCW

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 及以上 (成人、年长者)

接受健康志愿者

是的

有资格学习的性别

全部

取样方法

非概率样本

研究人群

Participants with end stage renal disease:

Patients will be recruited from the University Hospitals Coventry & Warwickshire hemodialysis unit identified by the research team and renal medical professionals.

Healthy participants:

Healthy participants will be recruited from Coventry University database of previous research participants. This group will comprise of 20 participants, age and weight matched to the patients with ESRD.

描述

Participants with end stage renal disease

Inclusion criteria

  • On hemodialysis for at least 3 months.
  • 4 hours of dialysis 3 times per week.
  • Urea reduction rate of at least 65% during the three months before enrolment.
  • Age 18 years or older.
  • Able to complete the CPEX and CLE test.

Exclusion criteria

  • Clinically significant valvular insufficiency.
  • Clinically significant dysrhythmia.
  • Uncontrolled intra-dialytic blood pressure (systolic > 180, diastolic >95).
  • Excessive fluid accumulation between dialysis sessions (>3 liters).
  • Hemoglobin unstable (below 9.0 g/dL).
  • Ischemic cardiac event (<1 month).
  • Unable to exercise.
  • Morbidly obese (BMI > 40).
  • Clinically significant and still active inflammatory or malignant process.
  • Planned kidney transplant during the duration of study.

Healthy participants

Inclusion criteria

  • Age 18 years or older.
  • Able to complete the CPEX and CLE test.

Exclusion criteria

  • Significantly limiting disease or comorbidity which would prevent full participation in exercise testing or illicit an abnormal cardiorespiratory response to exercise.
  • Chronic kidney disease.

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

队列和干预

团体/队列
Participants with end stage renal disease

Cardiopulmonary exercise test

Cardiopulmonary exercise testing will be conducted on an electronically braked cycle ergometer using a ramped protocol with participants being required to pedal until exhaustion.

Constant load exercise test

Constant load exercise will be performed for 30 min on an electronically braked cycle ergometer whilst seated in a dialysis chair. Blood sampling and echocardiogram will be measured throughout.

Healthy participants

Cardiopulmonary exercise test

Cardiopulmonary exercise testing will be conducted on an electronically braked cycle ergometer using a ramped protocol with participants being required to pedal until exhaustion.

Constant load exercise test

Constant load exercise will be performed for 30 min on an electronically braked cycle ergometer whilst seated in a dialysis chair. Blood sampling and echocardiogram will be measured throughout.

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Gas analysis
大体时间:2 months
Measurement of O2/CO2 kinetics.
2 months

次要结果测量

结果测量
措施说明
大体时间
Echocardiogram
大体时间:2 months
Measurement of regional wall motion abnormalities.
2 months
Echocardiogram
大体时间:2 months
Measurement of ejection fraction.
2 months
Echocardiogram
大体时间:2 months
Measurement of cardiac output.
2 months
Blood samples
大体时间:2 months
Investigation of cardiac, inflammatory and hormonal response to exercise.
2 months
Non invasive cardiac output measurement (NICOM)
大体时间:2 months
Measurement of cardiac output during exercise,
2 months

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 研究主任:Dr Elizabeth Elizabeth、Coventry University
  • 首席研究员:Prof Derek Renshaw、Coventry University
  • 首席研究员:Prof Alfonso Jimenez、Coventry University
  • 首席研究员:Prof Nithya Krishnan、Coventry University

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2017年6月13日

初级完成 (实际的)

2019年1月31日

研究完成 (实际的)

2019年9月23日

研究注册日期

首次提交

2017年2月18日

首先提交符合 QC 标准的

2017年2月21日

首次发布 (实际的)

2017年2月27日

研究记录更新

最后更新发布 (实际的)

2020年2月20日

上次提交的符合 QC 标准的更新

2020年2月19日

最后验证

2020年2月1日

更多信息

与本研究相关的术语

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

不

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

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