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临床试验/NCT04971408
NCT04971408已完成不适用

Passive Heating as an Accessible and Tolerable Strategy to Improve the Inflammatory Profile and Cardiometabolic Health in People With Spinal Cord Injury

VA Office of Research and Development1 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2022年7月1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
Interleukin-6

研究概览

简要总结

SCI results in higher incidence of heart disease and diabetes and heart disease is the most common cause of death. Chronic inflammation, deleterious changes in vascular structure and impaired glucose metabolism are risk factors that contribute to both heart disease and diabetes. While exercise can help reduce these risk factors, paralysis and impaired accessibility often precludes exercise in persons with SCI. New research in able-bodied persons demonstrates passive heating decreases inflammation and improves vascular function. Similar studies in persons with SCI suggest they may also have the same health benefits however these studies only investigated the impact of short term (one episode) passive heating (as opposed to repeated bouts). Repeated bouts of heat exposure will likely be required to impact chronic inflammation, but this has never been tested in persons with SCI. This study will test the impact of repeated bouts (3x/week) of passive heat stress over a longer term (8 weeks) on inflammation, metabolism and vascular function.

研究设计

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

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Stable SCI over 1 year of duration

排除标准

  • •Persons who smoke cigarettes
  • •Daily administration of anti-inflammatory medications
  • •Daily administration of vasoactive medications
  • •Pressure ulcer stage 3 or 4
  • •History of heat related illness

研究组 & 干预措施

Control

Other

Passive heat stress x1 visit then no intervention for 8 weeks. Participants continue regular exercise habits as usual.

干预措施: Control (Other)

Passive heat stress

Experimental

After arm 1, passive heat stress 3x/week x8 weeks.

干预措施: passive heat stress (Other)

结局指标

主要结局

Interleukin-6

时间窗: change from 0 weeks to 8 weeks to 16 weeks

Plasma concentration, which was determined using enzyme-linked immunosorbent assays.

次要结局

  • Maximal Cutaneous Vascular Conductance(change from 0 weeks to 8 weeks to 16 weeks)
  • Glucose Tolerance(change from 0 to 8 to 16 weeks)
  • TNF-alpha(change from 0 to 8 to 16 weeks)
  • Interleukin-1ra(change from 0 to 8 to 16 weeks)

研究者

申办方类型
Fed
责任方
Sponsor

研究点 (1)

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