Probing Metabolism, Circulating Inflammatory Molecules, Extracellular Vesicles and Immune Dysregulation in Individual Immune Cells in ME/CFS
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 173
- 试验地点
- 5
- 主要终点
- Volume of oxygen consumed at peak effort
研究概览
简要总结
This study aims to collect and identify key outcome measures or disease parameters in ME/CFS that are altered during elevated symptoms relative to baseline by gathering information before and after symptom provocation using a two-day cardiopulmonary exercise test.
详细描述
The phenomenon of post-exertional malaise (PEM), in which an ME/CFS patient's symptoms are elevated following even low-level exertion, is a hallmark feature of the disease. The cause of PEM, like the cause of ME/CFS, is not understood. This study aims to utilize a two-day CPET to invoke PEM. This provides a unique opportunity to collect data on how key outcome measures or disease parameters are altered during elevated symptoms relative to baseline within each patient by gathering information before and after symptom provocation.
A total of 90 participants and 90 controls will undergo CPET testing. Participation will be split amongst three different sites (Ithaca, NY, New York, NY, and Los Angeles, CA). Subjects will be located in urban and rural areas to establish relatively diverse study populations.
This study is a component of the Cornell ME/CFS Collaborative Research Center (CRC). Blood samples taken before and after CPET will be utilized in associated projects with the Cornell ME/CFS CRC. CPET data along with the analysis of blood samples has great potential to reveal why exercise negatively affects ME/CFS patients and thus perhaps why patients are also impaired even before increasing their activity level.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Diagnosed with ME/CFS
- •Adults 18 to 70 years of age
排除标准
- •Recent history of panic attacks within the past 6 months
- •Diagnosis of schizophrenia, major depressive disorder, bipolar disorder, or an anxiety disorder such as OCD or PTSD
- •Hospitalized for a psychological condition within the last 6 months
- •Unwilling to stop taking nutritional supplements, including probiotics, two weeks before the exercise tests.
- •Unwilling to stop pain medication and stimulant medication two days before the exercise tests.
- •Smoker, or stopped smoking less than 1 year ago
- •Pregnant or breastfeeding
- •Have an orthopedic limitation that prohibits cycle exercise
- •Excessive alcohol consumption
- •Healthy Volunteers:
- •Inclusion Criteria:
- •Low-active
- •Adults 18 to 70 years of age
- •Exclusion Criteria:
- •Recent history of panic attacks within the past 6 months
- •Diagnosis of schizophrenia, major depressive disorder, bipolar disorder, or an anxiety disorder such as OCD or PTSD
- •Hospitalized for a psychological condition within the last 6 months
- •Unwilling to stop taking nutritional supplements, including probiotics, two weeks before the exercise tests.
- •Unwilling to stop pain medication and stimulant medication two days before the exercise tests.
- •Smoker, or stopped smoking less than 1 year ago
- •Pregnant or breastfeeding
- •Have an orthopedic limitation that prohibits cycle exercise
- •Excessive alcohol consumption
结局指标
主要结局
Volume of oxygen consumed at peak effort
时间窗: During intervention on day 1 and during intervention on day 2; assessed through study completion, approximately 4 years from study start date.
Volume of oxygen consumed at peak effort during CPET 1 and during CPET 2.
Volume of oxygen consumed at ventilatory/anaerobic threshold (VAT)
时间窗: During intervention on day 1 and during intervention on day 2; assessed through study completion, approximately 4 years from study start date.
VAT is a non-invasive surrogate measure for anaerobic threshold, which is indicated during incremental exercise by a non-linear increase in rate of carbon dioxide production relative to rate of oxygen consumption.
Rate of work performed at VAT
时间窗: During intervention on day 1 and during intervention on day 2; assessed through study completion, approximately 4 years from study start date.
Rate of work performed at VAT during CPET 1 and during CPET 2. Rate of work is measured in Watts.
Rate of work performed at peak effort
时间窗: During intervention on day 1 and during intervention on day 2; assessed through study completion, approximately 4 years from study start date.
Rate of work performed at peak effort during CPET 1 and during CPET 2. Rate of work is measured in Watts.
Systolic blood pressure at seated rest
时间窗: During intervention on day 1 and during intervention on day 2; assessed through study completion, approximately 4 years from study start date.
Systolic blood pressure at seated rest 1-minute before the start of CPET 1 and 1-minute before the start of CPET 2.
Systolic blood pressure at peak effort
时间窗: During intervention on day 1 and during intervention on day 2; assessed through study completion, approximately 4 years from study start date.
Systolic blood pressure at peak effort during CPET 1 and during CPET 2.
Respiratory Exchange Ratio (RER) at peak effort
时间窗: During intervention on day 1 and during intervention on day 2; assessed through study completion, approximately 4 years from study start date.
RER at peak effort during CPET 1 and during CPET 2. RER is calculated as the rate of carbon dioxide production divided by the rate of oxygen consumption, and during exercise is an indicator of participant effort.
Heart rate at peak effort
时间窗: During intervention on day 1 and during intervention on day 2; assessed through study completion, approximately 4 years from study start date.
Heart rate at peak effort during CPET 1 and during CPET 2.
Heart rate at VAT
时间窗: During intervention on day 1 and during intervention on day 2; assessed through study completion, approximately 4 years from study start date.
Heart rate at VAT during CPET 1 and during CPET 2.
次要结局
未报告次要终点