POTS-CFS Study: A Case-Control Study on Exertion and Orthostatic Intolerance in the Context of Pediatric ME/CFS
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Blood Pressure during Passive 10-min. standing test
研究概览
简要总结
Pilot-case-control study on exertion and orthostatic intolerance of adolescents with myalgic encephalomyelitis/ chronic fatigue syndrome (ME/CFS) compared to age-matched healthy controls (HC).
详细描述
ME/CFS is a complex disease. Symptoms include orthostatic intolerance (OI) such as postural tachycardia syndrome (PoTS). PoTS in ME/CFS can significantly impair everyday function and social participation. Yet, data in affected adolescents are rare and inconsistent.
This pilot-case-control study study aimed at characterizing OI in adolescents aged 14-17 years with ME/CFS and age-adapted HC, comparing the results with other clinical features of both such as exertion intolerance, fatigue, and health-related quality of life, and suggesting a standardized tool for diagnostics.
ME/CFS was diagnosed according to the Clinical Canadian Criteria (CCC 2003), criteria of the former Institute of Medicine (IOM 2015), the diagnostic work sheet developed by Rowe 2017, and/or the pediatric case suggested by Jason 2006. Questionnaires were used to evaluate symptoms (e.g. post-exertional malaise, fatigue, anxiety, depression), and health-related quality of life. A standardized specific interview was performed to assess the medical history of OI (HOI). Heart rate (HR) and blood pressure were evaluated every minute during a passive 10-min standing test (NASA lean test) in the morning with empty stomach and without morning medication.
Data were evaluated according to the PoTS criteria defined in 2019 at the National Institutes of Health Expert Consensus Meeting and by the International Classification of Diseases (ICD-11) (8D89.2). Frequency and type of OI, including PoTS, were examined in both groups and outcomes compared to parameters from questionnaires. Based on the results, novel standards for OI diagnostics were suggested.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 14 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Cases (ME/CFS):
- •ME/CFS diagnosed by the indicated clinical criteria
- •Healthy Controls
- •clinically healthy
- •no known underlying disease
- •no prescription medication (except contraception)
排除标准
- •Any contraindication for NASA lean test (cardiac failure, severe aortic stenosis, inability to stand)
- •pregnancy
- •breastfeeding.
结局指标
主要结局
Blood Pressure during Passive 10-min. standing test
时间窗: one time point during study from study start until study completion, approximately 1 year
blood pressure, pulse pressure (calculated by systolic and diastolic blood pressure) during Passive 10-Min. standing test (NASA lean test)
Symptoms during Passive 10-Min. standing test
时间窗: one time point during study from study start until study completion, approximately 1 year
Symptoms during Passive 10-Min. standing test (NASA lean test): Yes/No
O2-Saturation during Passive 10-Min. standing test
时间窗: one time point during study from study start until study completion, approximately 1 year
O2-Saturation during Passive 10-Min. standing test (NASA lean test)
Self-estimated level of Quality of Life: EQ-5D-5L: Visual Analog Scale
时间窗: one time point during study from study start until study completion, approximately 1 year
Visual Analog Scale (0 worst - 100 best)
Heart Rate during Passive 10-min. standing test
时间窗: one time point during study from study start until study completion, approximately 1 year
Heart rate during Passive 10-Min. standing test (NASA lean test)
Presence of Orthostatic Intolerance: Semistructured Interview
时间窗: one time point during study from study start until study completion, approximately 1 year
Semistructured Interview, History of Orthostatic Intolerance (OI): Yes/No
Number of orthostatic Symptoms: Semistructured Interview
时间窗: one time point during study from study start until study completion, approximately 1 year
Semistructured Interview, Number of Symptoms
Number of participants with a diagnosis of PoTS, Orthostatic Intolerance and related diagnoses
时间窗: one time point during study from study start until study completion, approximately 1 year
History of OI and Nasa lean test together result in an orthostatic diagnosis, Fulfilling of PoTS-Criteria at study visit is evaluated
Presence of Post-exertional malaise (DePaul Symptom Questionnaire -Post exertional Malaise: DSQ-PEM)
时间窗: one time point during study from study start until study completion, approximately 1 year
Questionnaire, Binary Outcome: Post-exertional Malaise Yes/No
Self-estimated level of Quality of Life: EQ-5D-5L: Index
时间窗: one time point during study from study start until study completion, approximately 1 year
Questionnaire: Index (0 worst - 1 best)
Presence of ME/CFS-specific Symptoms (Munich Berlin Symptom Questionnaire)
时间窗: one time point during study from study start until study completion, approximately 1 year
Questionnaire: number of relevant symptoms. Likert Scale "0-4" of severity and frequency for each symptom: A symptom is relevant with a severity and frequency of each at least "2" on the Likert Scale. Minimum: 0 relevant symptoms (best), Maximum: 60 relevant symptoms (worst).
Screening via Public Health Questionnaire-4 (PHQ-4)
时间窗: one time point during study from study start until study completion, approximately 1 year
Ultra-Short-4-item-Screening for Anxiety/Depression: Scale (0 Symptom occurs never - 3 Symptom occurs almost every day)
Malmö PoTS Score (MAPS)
时间窗: one time point during study from study start until study completion, approximately 1 year
Orthostatic Symptoms Severity, Scale (0 no symptom burden - 120 highest symptom burden)
次要结局
- Levels of serum antibodies against SARS-CoV-2(one time point during study from study start until study completion, approximately 1 year)
- Levels of serum antibodies against EBV(one time point during study from study start until study completion, approximately 1 year)
- Levels of serum autoantibodies(one time point during study from study start until study completion, approximately 1 year)