跳至主要内容
临床试验/NCT03219749
NCT03219749已完成不适用

Examining the Effects of Exercise on Vascular Function in Obstructive Sleep Apnea

Towson University1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2017年1月15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
60
试验地点
1
主要终点
Change in flow mediated dilation of the brachial artery

研究概览

简要总结

Obstructive sleep apnea (OSA) results in vascular dysfunction, which increases the risk of cardiovascular disease. In contrast, exercise confers cardioprotection through improvements in vascular health. This proposal evaluates whether the beneficial effects of exercise on vascular function are attenuated in obese individuals suffering from untreated OSA.

详细描述

Obstructive sleep apnea (OSA) is a serious medical condition that affects an estimated 15 million US adults and is characterized by repeated episodes of upper airway obstruction, recurrent arousals and episodic oxyhemoglobin desaturations during sleep. These abnormalities contribute to subclinical alterations in vascular function that increase the risk of cardiovascular disease morbidity and mortality. In contrast, exercise decreases the risk of cardiovascular events and the promotion of physical activity continues to be at the top of our national public health agenda, as seen in the publication of the 1996 report of the US Surgeon General on physical activity and health. While the exact mechanisms for this protective benefit are not entirely clear, there is good evidence that exercise confers cardioprotection through its direct impact on vascular endothelial function. The American College of Sleep Medicine recommends exercise as a behavioral treatment option for OSA. Yet, most clinical trials upon which this recommendation is based have focused on establishing the effectiveness of lifestyle change (e.g., dietary induced weight loss and increased physical activity participation) for improving OSA severity in obese individuals, whereas less attention has been given to whether OSA moderates the effects of exercise on the cardiovascular disease substrate. The overarching hypothesis of this study is that OSA attenuates the beneficial effect of exercise on vascular function in obese individuals suffering from untreated OSA. The aims of the study are to 1) examine parameters of vascular function in obese persons with and without OSA, 2) evaluate the effects of an acute bout of exercise on brachial artery flow mediated dilation in obese persons with and without OSA, and 3) examine the effects of 6 weeks of exercise training on vascular function among those with and without OSA. These data will be immediately useful in clinical practice and inform how clinicians prescribe exercise and implement lifestyle changes to reduce cardiovascular disease risk in OSA patients.

研究设计

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

入排标准

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

入选标准

  • •BMI between 30 and 42

排除标准

  • •Apnea-hypopnea index > 60 events (confirmed with overnight sleep study)
  • •Currently participating in an exercise program as defined as a minimum of moderate exercise > 30 minute/day, > 3 times or 90 minutes per week
  • •Participating in a weight loss program and NOT weight stable for 3 months
  • •History of heart disease
  • •Uncontrolled hypertension
  • •Cigarette smoking in the last 6 months
  • •Type 1 diabetes
  • •Women who are pregnant
  • •Currently using hormonal replacement therapy
  • •Comorbid conditions including concern, peripheral arterial disease, renal disease, lung disease, thyroid diseases, osteoporosis and arthritis with chronic joint pain

研究组 & 干预措施

Exercise Intervention

Experimental

Exercise training will take place three times per week for six weeks and involve both aerobic and resistance exercise.

干预措施: exercise training (Behavioral)

结局指标

主要结局

Change in flow mediated dilation of the brachial artery

时间窗: This outcome will be assessed at baseline and at 6 weeks

Flow mediated dilation (in %) of the brachial artery will be assessed by vascular ultrasound

次要结局

  • exercise stress test(This outcome will be assessed at baseline and at 6 weeks)
  • dual energy X-ray absorptiometry(This outcome will be assessed at baseline and at 6 weeks)
  • blood draw(This outcome will be assessed at baseline and at 6 weeks)

研究者

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

Devon Dobrosielski

Assistant Professor

Towson University

研究点 (1)

Loading locations...

相似试验