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PEM, a Starting Point to Investigate and Understand ME/CFS

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Observational
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. 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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: t
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• 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.

Locations
Other Locations
Netherlands
UMC Groningen
RECRUITING
Groningen
Contact Information
Primary
Inge Zijdewind, Dr
c.a.t.zijdewind@umcg.nl
0625647190
Backup
Leda Maffei
l.b.maffei@umcg.nl
0625647190
Time Frame
Start Date: 2024-05-01
Estimated Completion Date: 2027-07-31
Participants
Target number of participants: 100
Treatments
ME/CFS
50 patients diagnosed with ME/CFS according to the International Consensus Criteria (ICC) and Canadian Consensus Criteria (CCC) will be included
Control
50 sex, age and activity matched controls will be included
Related Therapeutic Areas
Sponsors
Leads: University Medical Center Groningen

This content was sourced from clinicaltrials.gov

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