PEM, a Starting Point to Investigate ME/CFS (PEM_CFS)
2026年7月14日 更新者：University Medical Center Groningen
PEM, a Starting Point to Investigate and Understand ME/CFS
Exercise is an important contributor to general health and is considered a potential remedy for chronic diseases.
This is in strong contrast with the observation that in most myalgic encephalomyelitis (ME/CFS) patients exercise aggravates their symptoms.
Recently, post-exertional malaise (PEM) is defined as the key symptom of ME/CFS.
The etiology and pathophysiological mechanisms underlying ME/CFS are still unknown and objective diagnostic criteria are not available.
Various hypotheses are postulated including disorders of several organ systems but the heterogenous presentation of symptoms in patients, and the multisystem deficits complicate reaching an all-encompassing hypothesis.
It seems therefore reasonable to focus on the key symptom, i.e., PEM.
PEM can be induced by minor cognitive or physical exertion and can be assessed with questionnaires.
Acute physical activity triggers complex cardiovascular, metabolic, and molecular responses and for ME/CFS, hence it is important to understand the relation between these acute processes and the prolonged presentation of aggravated symptoms (PEM).
We therefore want to measure metabolites, cardiovascular responses, cognitive performance, muscle force and fatigability in 50 patients and 50 controls matched on group level for sex, age, and activity.
To follow changes in these parameters we perform time-series analysis, including data obtained before, during and after task performance.
Besides understanding these interactions, it is also essential to understand how these acute and prolonged responses affect behaviour and perception.
研究概览
研究类型
观察性的
注册 (估计的)
100
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习联系方式
- 姓名：Inge Zijdewind, Dr
- 电话号码：0625647190
- 邮箱：c.a.t.zijdewind@umcg.nl
研究联系人备份
- 姓名：Leda Maffei
- 电话号码：0625647190
- 邮箱：l.b.maffei@umcg.nl
学习地点
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Groningen、荷兰、9713VB
- 招聘中
- UMC Groningen
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接触：
- Inge Zijdewind
- 邮箱：c.a.t.zijdewind@umcg.nl
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接触：
- Leda Maffei
- 电话号码：0625647190
- 邮箱：l.b.maffei@umcg.nl
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
是的
取样方法
非概率样本
研究人群
Patients with diagnosed ME/CFS according to the international consensus criteria or the canadian consensus criteria and 50 controls matched on group level for age, sex, and activity.
描述
Inclusion Criteria:
- Willing and be able to complete all study procedures
- Able to provide informed consent
Additional inclusion criteria for ME/CFS patients
- ME/CFS patients have to meet the criteria of the ICC OR CCC.
- A self-reported illness narrative of the development of persistent fatigue and post-exertional malaise according to the DSQ-2. The persistent fatigue may have an acute onset or become progressively worse over 6 months.
Exclusion Criteria:
- Use of immune-modulating drugs in the past 3 months.
- A serious medical condition that may explain symptoms similar to ME/CFS, such as cancer, coronary artery disease, uncontrolled diabetes, chronic infection (hepatitis B and C, tuberculosis, HIV), inflammatory diseases, autoimmune diseases (e.g. such as rheumatoid arthritis, lupus or polymyositis), severe COPD or other severe persistent respiratory disease, severe anemia, renal failure, Addison's or Cushing's disease or severe neurological disease (such as Parkinson's disease).
- History of head injury with loss of consciousness or amnesia lasting greater than a few seconds within last five years or lasting greater than 5 minutes at any point during their lifetime. Persons with medical record evidence of post-concussive symptoms lasting more than six months are also excluded.
- Suspected, probable, or confirmed Lyme disease
- Current or substance use disorder within last 5 years
- A mood disorder or other psychiatric diagnosis prior to a diagnosis of ME/CFS.
- Pregnant, actively seeking to become or breastfeeding in the past 12 months.
- BMI >35.
- having cognitive or communication problems which reduces the capacity to understand instructions.
- planned a change in medication during the testing period.
- Use of medication that affects the blood pressure (e.g. Beta-blockers, fludrocortisone, vasoconstrictors).
- Participation in a clinical protocol (e.g. anti-inflammatory drug intervention study) which includes an intervention that may affect the results of the current study.
- Claustrophobia
- Current (within 1 week) use of prescription or over-the-counter medications, herbal supplements, or nutraceuticals that may influence brain excitability that the potential participant is either unwilling or clinically unable to safely wean off for the duration of the period of the visits. The possibility for a potential participant to be weaned off medication will be cooperatively determined by both the clinical investigative team and personal physicians. Examples of medications that influence brain excitability include tricyclic antidepressants, hypnotic, antiepileptic, antipsychotic medication, stimulants, antihistamines, muscle relaxants, dopaminergic medications, and sleep medications.
- Use of B12 high dosage injections
- Being colorblind
Additional exclusion criteria for control subjects:
- performing high intensity or moderate intensity activities more than 30 minutes per week
- substantial fatigue as determined using MFIS fatigue questionnaire >30
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
队列和干预
团体/队列 |
干预/治疗 |
|---|---|
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ME/CFS
50 patients diagnosed with ME/CFS according to the International Consensus Criteria (ICC) and Canadian Consensus Criteria (CCC) will be included
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Investigation of the pathophysiology of PEM in ME/CFS patients and matched controls
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Control
50 sex, age and activity matched controls will be included
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Investigation of the pathophysiology of PEM in ME/CFS patients and matched controls
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Cardiovascular parameters (Heart rate and blood pressure)
大体时间：2023-2027
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Heart rate (bpm) and blood pressure (mmHg) are measured with a continuous non-invasive monitoring system (Finapres Midi).
The BP sensor is positioned around the middle finger on the second phalanx of the left hand and subjects must hold their arm at breast level.
The recorded values during T1 and T2 will be compared between tasks, as well as between groups and sessions.
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2023-2027
|
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Short maximal voluntary contraction
大体时间：2023-2027
|
Short isometric maximal voluntary contractions (MVC) of the right index finger abductor (FDI).
The maximal index finger abduction force (newton) is measured with a force transducer which is held by the participant.
The measurement is repeated 3 times per hand and the highest value is taken.
On the second and third repetition, a superimposed twitch stimulation (SIT) will be induced to assess the voluntary activation during maximal contraction.
|
2023-2027
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Submaximal voluntary contractions (20%,40%, 60% of the short MVC)
大体时间：2023-2027
|
The participant is asked to produce force at different submaximal force targets (20%, 40%, 60%).
The targets are presented on a monitor and subjects get online feedback of the target force and their produced force.
|
2023-2027
|
|
Sustained maximal voluntary contraction of the FDI
大体时间：2023-2027
|
The participant performs a maximal contraction for 2 minutes.
During the 2 minutes contraction 7 SIT stimulation are given to the subject to assess voluntary muscle activation during a fatiguing task.
|
2023-2027
|
|
Cognitive parameters (stroop task)
大体时间：2023-2027
|
This test assesses the ability to inhibit cognitive interference, which occurs when the processing of a stimulus feature affects the simultaneous processing of another attribute of the same stimulus.
Participants see a word describing a colour on a screen, the word is written in the same or different colour than the word they will read.
They are asked to press a yes or no button to indicate whether the colour of the word and the meaning of the word matches (yes) or not (no).
The number of correct answers and the reaction time will be assessed.
|
2023-2027
|
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BOLD activation
大体时间：2023-2027
|
Blood oxygenation level dependent (BOLD): changes both in oxy- and deoxyhemoglobin concentration.
Brain activation in different tasks will be compared between groups and sessions.
|
2023-2027
|
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Arterial Spin Labeling (ASL)
大体时间：2023-2027
|
Is a non-invasive fMRI technique that uses arterial water as an endogenous tracer to measure cerebral blood flow.
ASL provides reliable absolute quantification of cerebral blood flow with high spatial and temporal resolution.
Perfusion data are used to identify patients suffering from impaired autoregulation of cerebral blood flow and to obtain associations with cardiovascular responses and muscle fatigue.
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2023-2027
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Cerebral oxygenation (near infrared spectroscopy)
大体时间：2023-2027
|
Oxy- and deoxyhemoglobine concentrations are measured at the prefrontal cortex and leg muscle with a non-invasive near infrared spectroscopy device (NIRS), where small sensors are positioned on the forehead and the quadriceps muscle.
For this measurement a standardized vascular occlusion test will be performed on the quadriceps muscle to assess the local tissue oxygen consumption and the microvascular reperfusion and reactivity.
This measurement will be used as calibration to normalize per subject the oxy- and deoxyhemoglobin concentrations allowing for comparisons between subjects.
The oxygenated and deoxygenated values for the prefrontal cortex and leg muscle will be compared across tasks, groups and sessions.
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2023-2027
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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30 Chair to stand test
大体时间：2023-2027
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This test assesses functional lower extremity strength.
Subjects sit on a chair and stand up repeatedly for 30 s. Arms of the subject are crossed and held against the chest.
The number of cycles of standing up from sitting are counted.
|
2023-2027
|
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Handgrip force (kg)
大体时间：2023-2027
|
MVC of the handgrip is measured with a hydraulic hand dynamometer (JAMAR Hand Dynamometer).
The measurement is repeated 3 times.
|
2023-2027
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Activity monitor
大体时间：2023-2027
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To measure routine activities in daily life, participants will be asked to wear an activity device (Actigraph) on their dominant hip as well as a heart rate device (polar H10) around their chest. During the 7 days of wearing the devices participant will be asked to fill out an activity diary. The difference in activity level and heart rate variables will be compared across the groups. |
2023-2027
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Blood samples
大体时间：2023-2027
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The blood samples are used to analyse the short-lasting changes in metabolites before and after the performance of physical and cognitive tasks and long-lasting changes on the next day
|
2023-2027
|
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Knee extension force
大体时间：2023-2027
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Maximal voluntary force (MVC) of the knee extensors is measured with a custom-built dynamometer.
Subjects are seated in a chair with the knee and hip in 90° of flexion with their non-dominant lower leg strapped to the chair's lever arm (~ 10 cm up to lateral malleolus).
Subjects are instructed to contract their knee extensors as rapidly and forcefully as possible and to maintain force generation for 5 s.
MVC is determined as the peak force.
|
2023-2027
|
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Chalder fatigue scale
大体时间：2023-2027
|
Is a questionnaire used to measure the severity of tiredness in fatiguing illnesses.
Scores per question range from 0 to 3. The higher the score the more fatigue experienced.
|
2023-2027
|
|
SF-36
大体时间：2023-2027
|
It is a multipurpose, short-form health survey with 36 questions.
It yields an eight-scale profile of scores as well as physical and mental health summary measures.
It is useful in comparing general and specific populations and comparing the relative burden of diseases.
Higher scores indicate a better health status.
|
2023-2027
|
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DePaul Symptoms Questionnaire 2 (DSQ-2)
大体时间：2023-2027
|
DSQ-2 is a questionnaire that assesses the key symptoms of ME/CFS.
At each item, participants have to rate the frequency and severity of the symptom on a scale from 0 to 4. The higher the scores the worse the symptoms.
|
2023-2027
|
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Bell disability scale
大体时间：2023-2027
|
Bell scale is a scale that describes the levels of physical and mental activity health.
The scores range from 0 to 100, the higher the score the better the health.
|
2023-2027
|
|
Pittsburgh sleep quality index
大体时间：2023-2027
|
Is a questionnaire assessing sleep quality and disturbances.
The higher the score the worse the sleep quality.
|
2023-2027
|
|
Hospital Anxiety and Depression Scale
大体时间：2023-2027
|
Is a questionnaire to determine levels of anxiety and depression that a person is experiencing.
Higher scores reflect a stronger impact.
|
2023-2027
|
|
Composite Autonomic Symptom Score 31
大体时间：2023-2027
|
Is a questionnaire of 31 questions that assesses the autonomic nervous system symptoms.
Higher score indicates greater autonomic symptom severity.
|
2023-2027
|
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Modified Fatigue Impact Scale (MFIS)
大体时间：2023-2027
|
Is a questionnaire related to sense of fatigue.
The questionnaire consists of 21 questions providing assessment of the effect of fatigue in terms of physical, cognitive, and psychosocial function.
Higher scores reflect a higher impact of fatigue.
|
2023-2027
|
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DePaul Post-Exertional Malaise Questionnaire (DPEMQ)
大体时间：2023-2027
|
Is a questionnaire that assesses the onset, triggers and recovery of PEM.
|
2023-2027
|
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EQ-5D
大体时间：2023-2027
|
Is a questionnaire that measures an individual's health status.
It has five dimensions on mobility, usual activities, self-care, pain and discomfort and anxiety and depression.
The higher the score the higher the impact on the quality of life.
|
2023-2027
|
|
Symptom severity score (SSS-12)
大体时间：2023-2027
|
Is a questionnaire that assesses the severity of 12 main symptoms from o to 10, with 10 being the most severe.
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2023-2027
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2024年5月1日
初级完成 (估计的)
2026年10月31日
研究完成 (估计的)
2027年7月31日
研究注册日期
首次提交
2024年3月29日
首先提交符合 QC 标准的
2026年7月14日
首次发布 (实际的)
2026年7月21日
研究记录更新
最后更新发布 (实际的)
2026年7月21日
上次提交的符合 QC 标准的更新
2026年7月14日
最后验证
2026年7月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.