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临床试验/NCT05924919
NCT05924919已完成不适用

The Effects of Passive Heat Therapy in Patients With Chronic Kidney Disease

Virginia Commonwealth University1 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2023年9月18日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
10
试验地点
1
主要终点
Renal Safety of Heat Therapy

研究概览

简要总结

The objective of this proposal is to investigate the acute effects of whole-body passive heat therapy using far-infrared technology on vascular function, exercise capacity, and renal function in CKD patients. The central hypothesis is that an acute bout of whole-body passive heat therapy will be well-tolerated and lead to acute improvements in large blood vessel (macrovascular) function, small blood vessel (microvascular) function, and exercise capacity without significantly altering markers of acute kidney injury.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Other
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

  • •for participants with CKD:
  • •Age > 18 years old
  • •Stage 2-4 CKD

排除标准

  • •for participants with CKD:
  • •Unstable medical conditions characterized by frequent or unpredictable biological, chemical, or psychological changes
  • •Uncontrolled hypertension
  • •Current fluid restrictions
  • •End stage kidney disease or currently on dialysis treatment
  • •Body weight < 40kg
  • •Exhibits any contraindications to exercise as per ACSM guidelines
  • •Regular tobacco and/or nicotine use
  • •History of heat-related illness
  • •Participates in regular exercise and/or sauna use
  • •Current hormone replacement therapy
  • •Pacemaker or electro-medical implant
  • •Persons with or at risk of intestinal disorders including gastroporesis
  • •History of diverticula
  • •Persons who have undergone surgical procedures in the GI tract
  • •Swallowing disorders
  • •Chron's disease
  • •Current pregnancy
  • •Inability to provide informed consent

研究组 & 干预措施

Experimental Arm: Whole-body Passive Heat Therapy (HT)

Experimental

Heat therapy will be administered using an infrared sauna. The intervention duration will last 25 minutes at a temperature of 60°C.

干预措施: Whole-body Passive Heat Therapy (HT) (Procedure)

Experimental Arm: Whole-body Passive Heat Therapy (HT)

Experimental

Heat therapy will be administered using an infrared sauna. The intervention duration will last 25 minutes at a temperature of 60°C.

干预措施: Thermoneutral Control (CON) (Procedure)

结局指标

主要结局

Renal Safety of Heat Therapy

时间窗: Change from baseline to 90 minutes after intervention

Change in urinary NGAL

Tolerability of Heat Therapy as Assessed using Validated Questionnaires of Thermal Perception

时间窗: During 25 minute intervention

Self reported perception of heat using the the Thermal Sensation Scale.

次要结局

  • Conduit artery endothelial function(90 minutes after intervention)
  • Lower Limb Microvascular Function(90 minutes after intervention)
  • Exercise Capacity(90 minutes after intervention)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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