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临床试验/NCT02101060
NCT02101060
已完成
不适用

Effect of Exercise Training on Inflammation and Function in HIV Infected Veterans

VA Office of Research and Development4 个研究点 分布在 1 个国家目标入组 33 人2014年9月15日
适应症HIV
干预措施exercise

概览

阶段
不适用
干预措施
exercise
疾病 / 适应症
HIV
发起方
VA Office of Research and Development
入组人数
33
试验地点
4
主要终点
Aerobic Capacity
状态
已完成
最后更新
10天前

概览

简要总结

Research is needed to determine safe and effective exercise rehabilitation programs to prevent and improve physical disability in older adults living with HIV. This problem is of great importance to the VA. The majority of the 25 thousand HIV-infected veterans are over 50 years of age (64%). The combined effect of aging and inflammation increase the risk for physical disability in older HIV-infected veterans. This translational exercise training trial will examine the cardiac and skeletal muscle effects of combined aerobic exercise and resistance training to attenuate the functional declines of aging with HIV by reducing the deleterious consequences of chronic inflammation. Findings will guide future rehabilitation research on cardiac remodeling and inflammation of skeletal muscle. The proposed research will advance the goal to develop effective rehabilitation strategies that improve the health of older HIV-infected veterans.

详细描述

The objective of this study is to determine the effect of exercise training on the central (cardiovascular) and peripheral (muscular) impairments underlying poor physical function by comparing older HIV-infected veterans randomized to combine aerobic and resistance exercise training versus usual care. The study hypothesis is that a progressive aerobic and resistance rehabilitation program will increase aerobic capacity and muscle strength, which will be mediated by improved diastolic function, increased muscle mass, and decreased systemic inflammation. To test this hypothesis, investigators will conduct a randomized 16-week trial of progressive aerobic and resistance training versus usual care control in 40 sedentary older (50+ years) HIV-infected veterans. The study will determine the effects of exercise training on aerobic capacity and diastolic function, and their relationship to changes in biomarkers of systemic inflammation and cardiac fibrosis (AIM 1). The study will also determine the effect of exercise training on strength and muscle mass, and their relationship to changes in biomarkers of systemic inflammation (AIM 2).

注册库
clinicaltrials.gov
开始日期
2014年9月15日
结束日期
2019年10月4日
最后更新
10天前
研究类型
Interventional
研究设计
Parallel
性别
All

研究者

责任方
Sponsor

入排标准

入选标准

  • HIV-infected veterans adult 50 years of age and older under medical care for HIV
  • Antiretroviral Therapy

排除标准

  • Patients with comorbid conditions that could have a potential impact on their ability to perform exercise testing and training will be excluded according to the American College of Sports Medicine
  • Only sedentary adults will be eligible. Individuals that participate in regular structured aerobic exercise or resistance training in the prior 6-months will be excluded

研究组 & 干预措施

exercise

16-week progressive aerobic and resistance exercise training

干预措施: exercise

control

usual care controls

结局指标

主要结局

Aerobic Capacity

时间窗: at baseline and at 16 weeks (before and after the intervention phase)

VO2 peak will be used as the primary measure of aerobic capacity. Subjects will be asked to exercise to voluntary exhaustion during a treadmill test using a modified Bruce protocol. In this Outcome, a mean difference between baseline to 16 weeks is reported (value at 16 weeks minus value at baseline).

Diastolic Function

时间窗: at baseline and at 16 weeks (before and after the intervention phase)

Exercise stress two-dimensional transthoracic echocardiography with tissue Doppler imaging (stress-echo) will be used to collect data on diastolic function. Reporting on ejection fraction. In this Outcome, a mean difference between baseline to 16 weeks is reported (value at 16 weeks minus value at baseline).

次要结局

  • Biomarkers of Systemic Inflammation(at baseline and at 16 weeks (before and after the intervention phase))

研究点 (4)

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