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.
調査の概要
研究の種類
観察的
入学 (推定)
100
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究連絡先
- 名前：Inge Zijdewind, Dr
- 電話番号：0625647190
- メール：c.a.t.zijdewind@umcg.nl
研究連絡先のバックアップ
- 名前：Leda Maffei
- 電話番号：0625647190
- メール：l.b.maffei@umcg.nl
研究場所
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Groningen、オランダ、9713VB
- 募集
- UMC Groningen
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コンタクト：
- Inge Zijdewind
- メール：c.a.t.zijdewind@umcg.nl
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コンタクト：
- Leda Maffei
- 電話番号：0625647190
- メール：l.b.maffei@umcg.nl
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参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
はい
サンプリング方法
非確率サンプル
調査対象母集団
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.
説明
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
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
コホートと介入
グループ/コホート |
介入・治療 |
|---|---|
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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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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Cardiovascular parameters (Heart rate and blood pressure)
時間枠：2023-2027
|
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.
|
2023-2027
|
|
Short maximal voluntary contraction
時間枠：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
|
|
Submaximal voluntary contractions (20%,40%, 60% of the short MVC)
時間枠：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
時間枠：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.
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2023-2027
|
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Cognitive parameters (stroop task)
時間枠：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.
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2023-2027
|
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BOLD activation
時間枠：2023-2027
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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)
時間枠：2023-2027
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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.
|
2023-2027
|
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Cerebral oxygenation (near infrared spectroscopy)
時間枠：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.
|
2023-2027
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
30 Chair to stand test
時間枠：2023-2027
|
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)
時間枠：2023-2027
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MVC of the handgrip is measured with a hydraulic hand dynamometer (JAMAR Hand Dynamometer).
The measurement is repeated 3 times.
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2023-2027
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Activity monitor
時間枠：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
時間枠：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
時間枠：2023-2027
|
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
時間枠：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
|
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SF-36
時間枠：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)
時間枠：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
|
|
Bell disability scale
時間枠：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
時間枠：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
時間枠：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
時間枠：2023-2027
|
Is a questionnaire of 31 questions that assesses the autonomic nervous system symptoms.
Higher score indicates greater autonomic symptom severity.
|
2023-2027
|
|
Modified Fatigue Impact Scale (MFIS)
時間枠：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
|
|
DePaul Post-Exertional Malaise Questionnaire (DPEMQ)
時間枠：2023-2027
|
Is a questionnaire that assesses the onset, triggers and recovery of PEM.
|
2023-2027
|
|
EQ-5D
時間枠：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)
時間枠：2023-2027
|
Is a questionnaire that assesses the severity of 12 main symptoms from o to 10, with 10 being the most severe.
|
2023-2027
|
協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (実際)
2024年5月1日
一次修了 (推定)
2026年10月31日
研究の完了 (推定)
2027年7月31日
試験登録日
最初に提出
2024年3月29日
QC基準を満たした最初の提出物
2026年7月14日
最初の投稿 (実際)
2026年7月21日
学習記録の更新
投稿された最後の更新 (実際)
2026年7月21日
QC基準を満たした最後の更新が送信されました
2026年7月14日
最終確認日
2026年7月1日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。