Cardiovascular Analysis of Post-exertional Malaise
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 106
- 试验地点
- 2
- 主要终点
- CPET testing
研究概览
简要总结
The purpose of this study is to examine cardiopulmonary function in Chronic Fatigue Syndrome (CFS) patients and determine how it relates to the common symptom of Post-exertional malaise (PEM). Subjects will complete a maximal exercise test on 2 subsequent days. Total blood volume will be measured prior to each exercise test, and patient with hypovolemia on day 1, will be randomized to either a saline or sham infusion prior to the 2nd exercise test. A total of 80 CFS patients will be enrolled.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 25 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Ages 25 to 60
- •Meet the 2015 IOM case definition for ME/CFS
排除标准
- •Patients with a medical cause for their fatigue
- •Patients taking medications that would dampen cardiac response to exercise
- •Patients with psychotic illness, bipolar disorder, or current major depressive disorder
- •Patients with a history of anorexia or bulimia within 5 years of intake
- •Patients with a history of alcohol or drug abuse within 2 years of intake
结局指标
主要结局
CPET testing
时间窗: 2 days
To assess VO2VT and peak VO2
Total Blood Volume
时间窗: 2 days
To measure Total Blood Volume (TBV) before each exercise test
Hypovolemia
时间窗: 1 day
Patients with reduced Total Blood Volume on day #1 CPET will be randomized in a 1:1 fashion to either a one hour infusion of a liter of isotonic saline prior to day #2 CPET or a sham infusion
次要结局
未报告次要终点
研究者
Benjamin Natelson
Professor, Neurology
Icahn School of Medicine at Mount Sinai