Myalgic Encephalomyelitis / Chronic Fatigue SyndromePEM_CFSNCT07715838
PEM, a Starting Point to Investigate ME/CFS
An observational study of Myalgic Encephalomyelitis / Chronic Fatigue Syndrome, run by University Medical Center Groningen at 1 site in Netherlands.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Myalgic Encephalomyelitis / Chronic Fatigue Syndrome
- How many people
- 100 participants
- Where
- 1 siteNetherlands
- Study dates
- 1 May 2024to 31 Jul 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: 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.
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 19Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Netherlands1 site, 1 recruiting
- Recruiting
UMC Groningen
Groningen, 9713VB
Leda Maffei, 0625647190, l.b.maffei@umcg.nl
Inge Zijdewind, c.a.t.zijdewind@umcg.nl
About this study
Official title: 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.
- Being tested
- No intervention is planned
- Keywords
- Post exertional malaise
- Medical subject headings
- Fatigue Syndrome, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No intervention is plannedOther
Investigation of the pathophysiology of PEM in ME/CFS patients and matched controls
| Study group | Role | What they receive |
|---|---|---|
| ME/CFS | 50 patients diagnosed with ME/CFS according to the International Consensus Criteria (ICC) and Canadian Consensus Criteria (CCC) will be included Receives: Other: No intervention is planned | |
| Control | 50 sex, age and activity matched controls will be included Receives: Other: No intervention is planned |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardiovascular parameters (Heart rate and blood pressure)
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.
Measured: 2023-2027
Short maximal voluntary contraction
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.
Measured: 2023-2027
Submaximal voluntary contractions (20%,40%, 60% of the short MVC)
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.
Measured: 2023-2027
Sustained maximal voluntary contraction of the FDI
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.
Measured: 2023-2027
Cognitive parameters (stroop task)
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.
Measured: 2023-2027
BOLD activation
Blood oxygenation level dependent (BOLD): changes both in oxy- and deoxyhemoglobin concentration. Brain activation in different tasks will be compared between groups and sessions.
Measured: 2023-2027
Arterial Spin Labeling (ASL)
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.
Measured: 2023-2027
Cerebral oxygenation (near infrared spectroscopy)
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.
Measured: 2023-2027
Secondary outcomes (16)
30 Chair to stand test
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.
Measured: 2023-2027
Handgrip force (kg)
MVC of the handgrip is measured with a hydraulic hand dynamometer (JAMAR Hand Dynamometer). The measurement is repeated 3 times.
Measured: 2023-2027
Activity monitor
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.
Measured: 2023-2027
Blood samples
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
Measured: 2023-2027
Knee extension force
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.
Measured: 2023-2027
Chalder fatigue scale
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.
Measured: 2023-2027
SF-36
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.
Measured: 2023-2027
DePaul Symptoms Questionnaire 2 (DSQ-2)
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.
Measured: 2023-2027
Bell disability scale
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.
Measured: 2023-2027
Pittsburgh sleep quality index
Is a questionnaire assessing sleep quality and disturbances. The higher the score the worse the sleep quality.
Measured: 2023-2027
Hospital Anxiety and Depression Scale
Is a questionnaire to determine levels of anxiety and depression that a person is experiencing. Higher scores reflect a stronger impact.
Measured: 2023-2027
Composite Autonomic Symptom Score 31
Is a questionnaire of 31 questions that assesses the autonomic nervous system symptoms. Higher score indicates greater autonomic symptom severity.
Measured: 2023-2027
Modified Fatigue Impact Scale (MFIS)
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.
Measured: 2023-2027
DePaul Post-Exertional Malaise Questionnaire (DPEMQ)
Is a questionnaire that assesses the onset, triggers and recovery of PEM.
Measured: 2023-2027
EQ-5D
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.
Measured: 2023-2027
Symptom severity score (SSS-12)
Is a questionnaire that assesses the severity of 12 main symptoms from o to 10, with 10 being the most severe.
Measured: 2023-2027
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2026
- Study start1 May 2024
- Primary completion31 Oct 2026 (estimated)
- Study completion31 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myalgic Encephalomyelitis / Chronic Fatigue SyndromeStudies of the same condition, open and under way.
- More trials run by University Medical Center GroningenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Medical Center Groningen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07715838
- Sponsor's protocol ID
- UMCG 17463
- Acronym
- PEM_CFS
- Status last verified
- Jul 2026
- First submitted
- 29 Mar 2024
- Last updated
- 21 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PEM, a Starting Point to Investigate and Understand ME/CFS
- ClinicalTrials.gov ID
- NCT07715838
- Acronym / sponsor ID
- PEM_CFS / UMCG 17463
- Keywords
- Post exertional malaise
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University Medical Center GroningenUniversity, hospital or other
- Study start
- 1 May 2024 (actual)
- Primary completion
- 31 Oct 2026 (estimated)
- Study completion
- 31 Jul 2027 (estimated)
- First posted
- 21 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ME/CFS | – | Other: No intervention is planned50 patients diagnosed with ME/CFS according to the International Consensus Criteria (ICC) and Canadian Consensus Criteria (CCC) will be included |
| Control | – | Other: No intervention is planned50 sex, age and activity matched controls will be included |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (19 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No intervention is plannedInvestigation of the pathophysiology of PEM in ME/CFS patients and matched controls | Other | Control, ME/CFS |
Primary outcome
Cardiovascular parameters (Heart rate and blood pressure)
Time frame: 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.
Short maximal voluntary contraction
Time frame: 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.
Submaximal voluntary contractions (20%,40%, 60% of the short MVC)
Time frame: 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.
Sustained maximal voluntary contraction of the FDI
Time frame: 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.
Cognitive parameters (stroop task)
Time frame: 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.
BOLD activation
Time frame: 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.
Arterial Spin Labeling (ASL)
Time frame: 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.
Cerebral oxygenation (near infrared spectroscopy)
Time frame: 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.
16 secondary outcomes
30 Chair to stand test
Time frame: 2023-2027
Handgrip force (kg)
Time frame: 2023-2027
Activity monitor
Time frame: 2023-2027
Blood samples
Time frame: 2023-2027
Knee extension force
Time frame: 2023-2027
Chalder fatigue scale
Time frame: 2023-2027
SF-36
Time frame: 2023-2027
DePaul Symptoms Questionnaire 2 (DSQ-2)
Time frame: 2023-2027
Bell disability scale
Time frame: 2023-2027
Pittsburgh sleep quality index
Time frame: 2023-2027
Hospital Anxiety and Depression Scale
Time frame: 2023-2027
Composite Autonomic Symptom Score 31
Time frame: 2023-2027
Modified Fatigue Impact Scale (MFIS)
Time frame: 2023-2027
DePaul Post-Exertional Malaise Questionnaire (DPEMQ)
Time frame: 2023-2027
EQ-5D
Time frame: 2023-2027
Symptom severity score (SSS-12)
Time frame: 2023-2027
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Myalgic Encephalomyelitis / Chronic Fatigue Syndrome, run by University Medical Center Groningen at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 21 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Inge Zijdewind, Dr (0625647190, c.a.t.zijdewind@umcg.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cardiovascular parameters (Heart rate and blood pressure) (time frame: 2023-2027). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jul 2026.