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临床试验/NCT04321603
NCT04321603撤回不适用

Altering Mechanisms of Frailty in Persons Living With HIV Aged 50 to 65

University of Maryland, Baltimore0 个研究点开始时间: 2020年5月30日最近更新:
适应症

试验速览

阶段
不适用
状态
撤回
主要终点
Mitochondrial Respiration PBMC and platelets

研究概览

简要总结

People living with HIV are living longer as their disease is controlled with antiretroviral medications. Yet they are experiencing frailty more often and more than ten years earlier than those without HIV. In elderly persons without HIV, frailty is associated with decreased muscle strength and chronic inflammation. Less is known about what is driving early frailty in HIV or effective prevention measures for aging adults with HIV.

It may be that having HIV infection impairs energy production by mitochondria within the cells and contributes to the muscle weakness and inflammation accompanying frailty in people living with HIV . This study will examine the impact of six weeks of moderately paced walking on energy production in the cells, inflammation markers and frailty scores in people living with well-controlled HIV who are aged 50 to 65.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Prevention
盲法
None

入排标准

年龄范围
50 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adults aged 50 to 65
  • Documentation of HIV infection from Medical Provider
  • Currently receiving antiretrovirals
  • HIV viral load less than 50 iu/mL for at least six months
  • CD4 count at least 350 cell/mm3 for the last six months
  • Willing and able to walk at least 30 minutes 3 times weekly within 30 minutes of UMB
  • Speaks English

排除标准

  • Current smokers
  • Weight less than 110 pounds
  • Subjects taking long-term corticosteroids equivalent to 10mg/day or more, or immunomodulators
  • Subjects with conditions known to affect inflammatory or mitochondrial function other than HIV, such as rheumatoid arthritis, gout, heart failure, chronic obstructive pulmonary disease, chronic kidney disease, diabetes, Parkinson's disease, Alzheimer's disease, active hepatitis, sleep apnea or autoimmune diseases.
  • Current drug or alcohol use or dependence or unstable mental health conditions that, in the opinion of the investigator, would interfere with adherence to study requirements

结局指标

主要结局

Mitochondrial Respiration PBMC and platelets

时间窗: Day 0, Week 6, Week 12 with intervention between weeks 6 and 12

Change in mitochondrial respiratory capacity after a six-week walking intervention

次要结局

  • Inflammation IL-1β(Day 0, Week 6, Week 12 with intervention between weeks 6 and 12 months)
  • Inflammation IL-6(Day 0, Week 6, Week 12 with intervention between weeks 6 and 12)
  • Inflammation IL-10(Day 0, Week 6, Week 12 with intervention between weeks 6 and 12)
  • Inflammation TNF-α(Day 0, Week 6, Week 12 with intervention between weeks 6 and 12)
  • Inflammation hsCRP(Day 0, Week 6, Week 12 with intervention between weeks 6 and 12)

研究者

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

Jennifer Klinedinst

Associate Professor

University of Maryland, Baltimore

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