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临床试验/NCT04922762
NCT04922762招募中不适用

Examining the Impact of Exercise Training on Vascular Dysfunction in Individuals With Mental Health Disorders - Study 2

Virginia Commonwealth University2 个研究点 分布在 1 个国家目标入组 360 人开始时间: 2021年12月6日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
360
试验地点
2
主要终点
Leg Vascular Function (Passive Leg Movement Test)

研究概览

简要总结

The purpose of this research study is to examine the effect of various forms of exercise training on blood vessel function in healthy individuals as well as individuals with mental health disorders (posttraumatic stress disorder (PTSD) and/or generalized anxiety disorder (GAD)).

详细描述

Study #2 is made up of five sessions done on five separate days and the entire study can be completed in as little as 14 weeks. All testing sessions will take place at the Exercise Physiology Research Laboratory. Volunteers will be asked to participate in one initial testing session (Visit 1) lasting < 1 hour that will help make them more familiar with the study equipment and procedures, determine body measures (height, weight, body fat), determine the maximum strength of their forearm and calf, and require one blood draw. The following two testing sessions (Visits 2 and 3) with each session lasting between 2-3 hours that will involve multiple tests designed to determine the health of their blood vessels. For Visit #2 they will be randomly given either antioxidant pills or placebo pills to determine the effect of oxidants on blood vessel health. For Visit #3, they will be given whatever set of pills (antioxidant or placebo) that they did not receive during Visit #2. also include two additional testing days (Visits 5 and 6) that are identical to Visits #2 and #3, two visits to test endurance or strength prior to and after the exercise training (Visit 4 and 7), and ten weeks of exercise training (done 3-5 days per week). The exercise training will include one of three treadmill running programs that differ by exercise intensity and/or exercise frequency.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Basic Science
盲法
None

入排标准

年龄范围
18 Years 至 35 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • apparently healthy and free of overt cardiovascular, pulmonary, or metabolic disease
  • for PTSD group, a score of ≥ 33 on PCL-5 checklist
  • for GAD group, a score of ≥ 10 on the GAD-7 self-report scale and < 33 on the PCL-5 checklist
  • for Healthy Control group, a score of ≤ 10 on the GAD-7 self-report scale and < 33 on the PCL-5 checklist

排除标准

  • taking medications that could influence cardiovascular function
  • current smokers who have recently quit smoking
  • illicit drug use or excessive alcohol consumption
  • pregnant women
  • significant calorie restriction or vitamin/mineral deficiencies
  • limited English proficiency

结局指标

主要结局

Leg Vascular Function (Passive Leg Movement Test)

时间窗: Baseline to the end of the final visit, about 14 weeks

Change in Leg Blood Flow Values from Baseline

Arm Vascular Function at Rest (Flow Mediated Dilation Test)

时间窗: Baseline to the end of the final visit, about 14 weeks

Change in Brachial Artery Dilation from Baseline Values

Arm Vascular Function in Response to Exercise (Handgrip Exercise Test)

时间窗: Baseline to the end of the final visit, about 14 weeks

Change in Brachial Artery Dilation from Baseline Values

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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