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临床试验/NCT04137068
NCT04137068Unknown不适用

Sedentary Behavior, Cardiovascular Function, and Sleep

Oregon Health and Science University2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2019年11月13日最近更新:
适应症

试验速览

阶段
不适用
入组人数
20
试验地点
2
主要终点
Endothelial Function

研究概览

简要总结

This is an interventional study that will examine how sedentary behavior (decreased physical inactivity) over time affects cardiovascular health (i.e. heart rate and blood pressure) and sleep quality/duration.

详细描述

PRIMARY OBJECTIVES:

  1. To test the hypothesis that two weeks of sedentary behavior will progressively impair vascular endothelial function.

2: To test the hypothesis that increasing sedentary behavior will decrease total sleep duration and sleep efficiency.

3: To test the hypothesis that two-weeks of sedentary behavior will progressively increase 24-h blood pressure and reduce nocturnal blood pressure dipping.

OUTLINE:

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
20 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Ages 20-80y
  • Lean and overweight (BMI 18.5-40 kg/m2)
  • No acute, chronic, or debilitating medical conditions
  • No prescription/non-prescription medications or drugs of abuse
  • Limited weight training or intense exercise (swimming, CrossFit)
  • Non-smoker
  • Average level of daily physical activity (8,000-12,499 steps/day)
  • Persons who fit all the above criteria and are suitable based on a medical history and health habits questionnaire, sleep profiling questionnaire, and electrocardiogram and clinical biochemical screening tests of blood and urine may be eligible to participate.

排除标准

  • Persons with any acute, chronic, or debilitating medical condition except pre-hypertension and/or mild to moderate sleep apnea will be excluded.
  • Persons with any symptoms of acute or active illness (e.g. fever, leukocytosis) will be excluded.
  • Persons with a history of severe psychiatric illness or psychiatric disorders will be excluded.
  • Persons with a history of regular night/or rotating shift work, or who have traveled more than three time zones during the one month prior to the study will be excluded.
  • Pregnant persons, decisionally impaired adults, and prisoners will be excluded.

结局指标

主要结局

Endothelial Function

时间窗: 3 weeks

Investigators will measure endothelial function as flow-mediated dilation at baseline, and each hour of the 3-hour sitting trials.

Oxidative stress

时间窗: 3 weeks

Oxidative stress will be measured using malondialdehyde adducts (MDA) from Ethylenediaminetetraacetic acid (EDTA) plasma.

Endothelin-1

时间窗: 3 weeks

Endothelin 1 (ET-1) will be measured from Ethylenediaminetetraacetic acid (EDTA) plasma.

Heart rate

时间窗: 3 weeks

During the weekly trials, heart rate will be measured as beats per minute while participants are in a seated position during the prolonged sitting period.

Blood pressure

时间窗: 3 weeks

During the weekly trials, blood pressure will be measured as systolic over diastolic in a seated position in the dominant arm

24-hour BP measurement

时间窗: 3 weeks

Investigators will measure 24-hour ambulatory blood pressure monitoring (AMBP, Spacelabs, Inc) at baseline and for 24-h before each in-lab visit.

Sleep duration

时间窗: 3 weeks

Sleep duration will be scored from the ActiGraph and correlated with the sleep and activity diary.

Sleep efficiency

时间窗: 3 weeks

Sleep efficiency will be scored from the ActiGraph and correlated with the sleep and activity diary.

Activity

时间窗: 3 weeks

Activity will be scored from the ActiGraph and correlated with the sleep and activity diary.

Activity Perception

时间窗: 3 weeks

Activity perception will be measured before each prolonged sitting trial using an Activity Perception questionnaire (Perception of Current Activity Questionnaire). The questionnaire has 7 questions with answers ranging from 1 to 5. The range of scores is from 7 to 35, with 7 suggesting a strong negative perception of current activity, and 35 suggesting a strong positive perception of current activity.

次要结局

未报告次要终点

研究者

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

Saurabh Thosar

Principal Investigator

Oregon Health and Science University

研究点 (2)

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