NL-OMON56099招募中不适用
Skeletal muscle structure and function in relation to post-exertional malaise in patients with PASC and ME/CFS - STOP PASC-ME/CFS
Amsterdam UMC0 个研究点目标入组 82 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 82
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18 至 64（—）
入选标准
- •In order to be eligible to participate in this study, a subject with PASC must
- •meet all of the following criteria:
- •* Non-hospitalized individuals with prior confirmed diagnosis of severe acute
- •respiratory coronavirus 2 (SARS-CoV-2) infection by reverse
- •transcription-polymerase chain reaction testing or serology (wantai) testing
- •* Individuals with diagnosed PASC by a post-covid physician
- •* >3 months of symptoms
- •* Post exertional malaise, according to the DSQ-PEM questionnaire or 1:1
- •interview with post-covid physician
- •* No symptoms present before confirmed diagnosis of severe acute respiratory
- •coronavirus 2
- •* Aged between 18-65 years
- •In order to be eligible to participate in this study, a subject with ME/CFS
- •must meet all of the following criteria:
- •* Fulfill the Canadian Consensus Criteria (CCC)
- •* Post exertional malaise, according to the DSQ-PEM questionnaire or 1:1
- •interview with post-covid physician
- •* >3 months of symptoms
- •* ME/CFS diagnosis <10 years ago
- •* Aged between 18-65 years
- •* Confirmed diagnosis of severe acute respiratory coronavirus2 (SARS-CoV-2)
- •infection by reverse transcription-polymerase chain reaction testing or
- •serology (wantai) testing
- •For the healthy controls:
- •* Aged between 18-65 years
- •* Confirmed diagnosis of severe acute respiratory coronavirus2 (SARS-CoV-2)
- •infection by reverse transcription-polymerase chain reaction testing or
- •serology (wantai) testing without admission
排除标准
- •A potential subject who meets any of the following criteria will be excluded
- •from participation in this study:
- •* History of asthma, stroke, chronic obstructive pulmonary disease, congestive
- •heart failure, heart surgery, or congenital heart diseases
- •* Severe illness (e.g., cancer, CHD, uncontrolled diabetes)
- •* Current treatment with drugs known to interfere with metabolism e.g. systemic
- •corticosteroids, statins, SGLT2 inhibitors, GLP1 receptor agonists or immune
- •modulatory drugs in the last three months.
- •* Severe psychiatric or mood disorders
- •* Are current smokers or have been a regular smoker within the last 12 months
- •* Insulin pump therapy
- •* Symptomatic autonomic or distal neuropathy
- •* BMI >35 due to adiposity, since this is known to cause difficulties in
- •obtaining muscle biopsies.
- •* Pregnancy
- •* Recent acute myocardial infarction (<6 months)
- •* Uncontrolled arrhythmia/severe conduction disorder (atrial fibrillation or
- •second/third degree AV block) causing hemodynamic compromise
- •* Implantable pacemaker or other cardiac device with complete ventricular
- •* Uncontrolled heart failure with hemodynamic compromise
- •* Uncontrolled hypertension (Systolic Blood Pressure >150 mmHg and Diastolic
- •Blood Pressure > 100 mmHg on repeated measurements)
- •* Active infection, anaemia, severe renal dysfunction (estimated Glomerular
- •filtration rate <30 ml/min/1,73m2) likely to significantly impact on exercise
- •performance
- •* > 6 alcohol units per day or >14 alcohol units per week
- •* Use of anticoagulants or anti platelet therapy
研究者
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