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临床试验/NCT02753868
NCT02753868已完成不适用

Acute Effects of Intradialytic Exercise on Cardiovascular Function in Hemodialysis Patients

University of Illinois at Urbana-Champaign2 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2016年2月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
12
试验地点
2
主要终点
Serial change in brachial blood pressure (mmHg) from start to end of a dialysis treatment

研究概览

简要总结

The purpose of this study is to examine the effect of cycling at mild to moderate intensity during hemodialysis treatment on cardiovascular function in a crossover design.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Receiving hemodialysis treatment three times per week, on hemodialysis for greater than three months, receive medical clearance from a Nephrologists

排除标准

  • Patients with established contraindications to exercise including lower-limb amputation, advanced chronic obstructive pulmonary disease and decompensated chronic heart failure.

结局指标

主要结局

Serial change in brachial blood pressure (mmHg) from start to end of a dialysis treatment

时间窗: Every 15 minutes throughout each dialysis treatment (approximately 4 hours)

Systolic and diastolic blood pressure will be measured using an automated blood pressure cuff attached to the clinic dialysis machine

Changes in cardiac output (mL/min) measured by thoracic impedance technique

时间窗: Continous throughout a dialysis treatment (approximately 4 hours)

Cardiac output will be estimated continuously using thoracic impedance with electrodes placed around the chest.

次要结局

  • Hypotensive event assessment measured by a symptom questionnaire(Throughout and up to 5 hours after completion of a dialysis treatment)
  • Changes in total peripheral resistance estimated by peripheral blood pressure via a finger plethysmography and cardiac output via thoracic impedance (Task Force Monitor)(Continuous throughout each dialysis treatment (approximately 4 hours) for three dialysis sessions that are separated by a week)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Kenneth Wilund

Associate Professor

University of Illinois at Urbana-Champaign

研究点 (2)

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