Using Advanced Imaging to Determine the Benefits of Exercise on Cardiovascular Risk in PTSD
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Heart rate
研究概览
简要总结
The purpose of this study is to use a non-invasive imaging technique called positron emission tomography/magnetic resonance imaging (PET/MRI) to investigate the effects of exercise on brain activity and arterial (blood vessel) inflammation in people with PTSD symptoms and evidence of or elevated risk for artery disease.
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
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-65 years
- •Trauma exposure
- •PTSD symptoms
- •Subclinical atherosclerotic CVD (e.g., coronary, cerebrovascular, or peripheral arterial plaque or calcifications on imaging), clinical atherosclerotic CVD (e.g., myocardial infarction or revascularization), or increased risk for atherosclerotic CVD (i.e., >2 of hypertension, diabetes mellitus, hyperlipidemia, and active smoking)
- •Ability to understand and sign informed consent
排除标准
- •History of stroke, brain surgery, or seizure
- •Use of certain CVD medications (e.g., beta-blockers, high-intensity statins [e.g., rosuvastatin 20/40 mg and atorvastatin 40/80 mg], PCSK-9 inhibitors)
- •Psychiatric or cardiovascular medication change within 4 weeks (i.e., stable regimen is allowed)
- •Unstable blood pressure or cardiac arrhythmia
- •Currently in a supervised or graduated exercise program
- •Neurological or systemic inflammatory disease/current systemic anti-inflammatory therapy
- •Moderate/severe alcohol/substance use disorder
- •Current mania/psychosis
- •Weight >300 lbs.
- •Claustrophobia
- •Pregnancy
- •Metal implants
- •Uncontrolled hyperglycemia (HgbA1c>7.5%)
- •Subjects who have had significant radiation exposure as part of research (>2 nuclear tests, computed tomography images, or fluoroscopic procedures) during the preceding 12-months
结局指标
主要结局
Heart rate
时间窗: Pre-treatment; Post-treatment (12-16 weeks after pre-treatment visit)
10-minute resting heart rate will be measured in beats per minute and collected from electrocardiogram (ECG)
Blood pressure
时间窗: Pre-treatment; Post-treatment (12-16 weeks after pre-treatment visit)
Systolic and diastolic blood pressure
Heart rate variability
时间窗: Pre-treatment; Post-treatment (12-16 weeks after pre-treatment visit)
10-minute resting heart rate variability will be measured using heart rate R-peak interval times collected from electrocardiogram (ECG)
Arterial inflammation
时间窗: Pre-treatment; Post-treatment (12-16 weeks after pre-treatment visit)
Aortic and carotid arterial inflammation will be based on uptake of 18F-fluorodeoxyglucose during positron emission tomography in these sites
Bone marrow inflammation
时间窗: Pre-treatment; Post-treatment (12-16 weeks after pre-treatment visit)
Bone marrow inflammation will be based on uptake of 18F-fluorodeoxyglucose during positron emission tomography
次要结局
未报告次要终点
研究者
Antonia V. Seligowski, PhD
Assistant Professor
Massachusetts General Hospital