Neural Control and Cardiac-Vascular Function in Women With PTSD (VA Psychological Assessment)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 24
- 试验地点
- 4
- 主要终点
- Muscle Sympathetic Nerve Activity (MSNA; Data collected by IEEM)
研究概览
简要总结
The purpose of this research is 1) to investigate the role of the sympathetic nervous system and cardiac-vascular function in women with PTSD; and 2) to determine whether lifestyle modifications (exercise training and healthy eating) would be effective in reducing sympathetic activity, improving cardiovascular function, and improving psychiatric and quality of life outcomes in women with PTSD. It is hypothesized that (1) women with PTSD will have over-activation of the sympathetic nervous system and impaired cardiac-vascular function compared with women who are trauma free, and (2) lifestyle modifications can reduce sympathetic activity, improve cardiac-vascular function, and improve psychiatric symptoms and quality of life in women with PTSD.
详细描述
This is a collaborative study between the Institute for Exercise and Environmental Medicine (IEEM; Texas Health Resources/University of Texas Southwestern medical Center) and VA North Texas Healthcare System (VANTHCS). The overall study was conceptualized and initiated by Dr. Qi Fu and her research team at the IEEM. IEEM researchers will be responsible for recruitment of non-veteran women without a diagnosis of PTSD, physiological assessments, and the lifestyle modification intervention. VANTHCS researchers will be responsible for recruitment of women veterans with PTSD and psychological assessments. The procedures taking place at VANTHCS (recruitment of women Veterans with PTSD and psychological assessments) will fall under a separate study (overseen by VANTCHS IRB and RDC) and will not include the procedures and intervention that will take place at the IEEM (which will be overseen by a separate IRB). Data will be shared between the sites per data sharing agreement. This clinical trials entry reflects the VANTHCS study. Outcome measures gathered by the IEEM research team are included in this entry due to the data sharing agreement.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Be either a female veteran with a current diagnosis of PTSD (for the PTSD group) or a female non-veteran without a current diagnosis of PTSD (for the non-PTSD control group).
- •Be between the ages of 18-
- •Sedentary (exercises less than three times a week for thirty minutes or less).
排除标准
- •Any evidence of cardiopulmonary and neurological diseases by history or by physical examination.
- •Chronic kidney disease (serum creatinine > 1.5 mg/dL).
- •Peripheral vascular disease.
- •Peripheral neuropathy.
- •Current substance use disorder other than tobacco related.
- •Endurance-trained athletes due to the effects of exercise training on sympathetic neural control and cardiac-vascular function.
- •Current pregnancy.
结局指标
主要结局
Muscle Sympathetic Nerve Activity (MSNA; Data collected by IEEM)
时间窗: +PTSD vs. -PTSD baseline comparison; Changes from baseline following 12-week intervention
Muscle sympathetic nerve activity will be measured using microneurography at the peroneal nerve.
Clinician Administered Posttraumatic Stress Disorder Scale - 5 (CAPS-5; Data collected by VANTHCS)
时间窗: Changes from baseline following 12-week intervention
CAPS-5 is a 30-item structured interview that corresponds to the DSM-5 diagnosis for PTSD. The instrument is used to make a current or lifetime diagnosis of PTSD, as well as assess symptom severity. Total symptom severity scores range from 0 to 80. A higher score indicates greater symptom severity. Individual symptom severity scores range from 0 (absent) to 4 (extreme/incapacitating) and are based on symptom frequency and intensity.
次要结局
- Quality of Life Enjoyment and Satisfaction Questionnaire - Short Form (Q-LES-Q-SF; data collected by VANTHCS)(Changes from baseline through 12-week intervention)
- Endothelial function (data collected by IEEM)(+PTSD vs. -PTSD baseline comparison; Changes from baseline following 12-week intervention)
- PTSD Checklist for DSM-5 (PCL-5; Data collected by VANTHCS)(Changes from baseline through 12-week intervention)
- Physical Fitness (Data collected by IEEM)(Changes from baseline following 12-week intervention)
- Systolic and diastolic cardiac function (Data collected by IEEM)(+PTSD vs. -PTSD baseline comparison; Changes from baseline following 12-week intervention)
- 36-Item Short Form Health Survey (SF-36; Data collected by IEEM)(+PTSD vs. -PTSD baseline comparison; Changes from baseline following 12-week intervention)
- Arterial stiffness (Data collected by IEEM)(+PTSD vs. -PTSD baseline comparison; Changes from baseline following 12-week intervention)
- Quick Inventory for Depressive Symptomatology-self report (QIDS- SR16; Data collected by VANTHCS)(Changes from baseline through 12-week intervention)
- Concise Health Risk Tracking Scale - self-report module (CHRT; data collected by VANTHCS)(Changes from baseline through 12-week intervention)
研究者
Geetha Shivakumar
Principal Investigator
North Texas Veterans Healthcare System