Are exercise-related symptom flare-ups specific to people with ME/CFS compared with patients who have heart conditions?

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Adults with ME/CFS (diagnosed by the 2011 International Consensus Criteria) and adults referred to cardiology for an exercise test with moderate to severe fatigue will undergo a standardized ergocycle exercise test while wearing near-infrared spectroscopy (NIRS) sensors. Participants will complete online symptom questionnaires before and after the test to track any worsening or new symptoms consistent with post-exertional malaise. The study compares the frequency and severity of symptom exacerbation between the ME/CFS group and the cardiac group to determine whether the response is specific to ME/CFS. Inclusion requires age 18 or older, ability to use a digital device for questionnaires, and informed written consent.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Aged ≥ 18 years
* For patients with Myalgic Encephalomyelitis / Chronic Fatigue Syndrome (ME/CFS): Clinical diagnosis of Myalgic Encephalomyelitis / Chronic Fatigue Syndrome according to the International Consensus Criteria (ICC) 2011.
* For patients with cardiac diseases : patients referred for an exercise test in the cardiology department for one of the following indications: palpitations, hypertension, exertional dyspnea, chest pain, cornoray artery disease and presence of moderate to severe fatigue defined as a Numerical Rating Scale (NRS) \> 3/10 during the last 8 days and no diagnosis of Myalgic Encephalomyelitis / Chronic Fatigue Syndrome.
* Ability to use a computer or digital device required to complete online questionnaires.
* Having given free and informed written consent

Exclusion Criteria:

* Pregnant or breastfeeding woman
* Persons deprived of their liberty by a judicial or administrative decision.
* Persons who are subject to a legal protection measure or who are unable to express their consent.

Where it's running

• Hôpital Européen Marseille
  Marseille, France Recruiting

Study contacts

• Study coordinator: Myriam BENNANI
• Email: m.bennani@hopital-europeen.fr
• Phone: 0413428351

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.