Acute Effects of Intradialytic Exercise on Cardiovascular Function in Hemodialysis Patients (ACE-HD)
研究概览
详细说明
Patients with kidney failure requiring hemodialysis (HD) treatment die at excessively high rates, despite advances in HD techniques and pharmacological therapies. This indicates additional therapeutic strategies are needed. Intradialytic exercise (IDEX, exercise during HD treatment) represents a low-cost, easy to administer treatment strategy that could potentially improve cardiovascular function, physical function and quality of life. However, nephrologists rarely counsel their patients to increase their physical activity levels or to exercise during HD treatment, in part due to a lack of understanding of IDEX knowledge.
Providing more robust evidence for the safety and effectiveness of IDEX, as well as evaluating the impact of exercising early vs late in the treatment, could help improve adoption of exercise training as a standard practice in HD clinics.
Therefore, investigators plan to examine the impact of IDEX and its timing during treatment (1st vs 3rd hour) on blood pressure and adverse symptoms in HD patients. The proposed study also includes various cardiovascular measures to allow deeper mechanistic understanding of cardiovascular physiology with IDEX. Such understanding will significantly advance the field and lead to improved therapeutic approaches, including exercise training, which may help mediate the deleterious effects of renal failure.
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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Illinois
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Urbana、Illinois、美国、61801
- University of Illinois at Urbana-Champaign
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Receiving hemodialysis treatment three times per week, on hemodialysis for greater than three months, receive medical clearance from a Nephrologists
Exclusion Criteria:
- Patients with established contraindications to exercise including lower-limb amputation, advanced chronic obstructive pulmonary disease and decompensated chronic heart failure.
学习计划
研究是如何设计的？
设计细节
- 主要用途：支持治疗
- 分配：随机化
- 介入模型：交叉作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：Standard Hemodialysis
Participants will be monitored during their normal hemodialysis treatment with no intervention administered
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Participants will receive a standard hemodialysis treatment during the study period
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实验性的：Hemodialysis with Exercise (1-st hr)
Participants will be monitored during a normal dialysis treatment in which they cycle at mild to moderate intensity for 30 minutes during 1-st hour into treatment
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Participants will receive a standard hemodialysis treatment during the study period
Participants will be asked to cycle at mild to moderate intensity for 30 minutes during either 1-st hour of 3-rd hour into treatment
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实验性的：Hemodialysis with Exercise (3-rd hr)
Participants will be monitored during a normal dialysis treatment in which they cycle at mild to moderate intensity for 30 minutes during 3-rd hour into treatment
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Participants will receive a standard hemodialysis treatment during the study period
Participants will be asked to cycle at mild to moderate intensity for 30 minutes during either 1-st hour of 3-rd hour into treatment
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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 |
|---|---|---|
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Serial change in brachial blood pressure (mmHg) from start to end of a dialysis treatment
大体时间：Every 15 minutes throughout each dialysis treatment (approximately 4 hours)
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Systolic and diastolic blood pressure will be measured using an automated blood pressure cuff attached to the clinic dialysis machine
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Every 15 minutes throughout each dialysis treatment (approximately 4 hours)
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Changes in cardiac output (mL/min) measured by thoracic impedance technique
大体时间：Continous throughout a dialysis treatment (approximately 4 hours)
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Cardiac output will be estimated continuously using thoracic impedance with electrodes placed around the chest.
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Continous throughout a dialysis treatment (approximately 4 hours)
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Changes in total peripheral resistance estimated by peripheral blood pressure via a finger plethysmography and cardiac output via thoracic impedance (Task Force Monitor)
大体时间：Continuous throughout each dialysis treatment (approximately 4 hours) for three dialysis sessions that are separated by a week
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A finger cuff will be placed around the non-dialyzing finger and will measure the change in peripheral blood pressure from successive beats continuously.
Total peripheral resistance will be estimated using measured cardiac output and peripheral blood pressure.
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Continuous throughout each dialysis treatment (approximately 4 hours) for three dialysis sessions that are separated by a week
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Hypotensive event assessment measured by a symptom questionnaire
大体时间：Throughout and up to 5 hours after completion of a dialysis treatment
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The presence of hypotensive-relating intradialytic symptoms including nausea, dizziness and cramping will be recorded.
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Throughout and up to 5 hours after completion of a dialysis treatment
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合作者和调查者
调查人员
- 首席研究员：Kenneth Wilund, PhD、University of Illinois at Urbana-Champaign
出版物和有用的链接
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
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)？
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.
Hemodialysis treatment的临床试验
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Zealand University HospitalUniversity of Copenhagen; Steno Diabetes Center Copenhagen; Holbaek Sygehus招聘中
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Universitaire Ziekenhuizen KU LeuvenLaboratoires Thea招聘中