Are exercise-related symptom flare-ups specific to people with ME/CFS compared with patients who have heart conditions?
Is Post-exertional Symptom Exacerbation Specific to Patients With Myalgic Encephalomyelitis / Chronic Fatigue Syndrome? A Study Comparing Patients With Myalgic Encephalomyelitis / Chronic Fatigue Syndrome and Patients With Cardiac Diseases Who Underwent an Exercise Test.
This trial will test whether a standard bicycle exercise test causes post-exertional symptom flare-ups in adults with ME/CFS compared with adults referred for cardiology exercise testing.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 80 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Hôpital Européen Marseille Academic / other |
| Locations | 1 site (Marseille) |
| Trial ID | NCT07491315 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 or older with a clinical diagnosis of ME/CFS per ICC 2011 or adults referred for a cardiology exercise test who report moderate to severe fatigue (NRS > 3) and can complete online questionnaires and attend testing at the study site.
Not a fit: People who are pregnant or breastfeeding, legally unable to consent or under legal protection, unable to use a digital device for online questionnaires, or who do not have ME/CFS or qualifying cardiac indications are unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, the findings could help clinicians distinguish post-exertional symptom flare-ups that are specific to ME/CFS from those seen in cardiac patients, improving diagnosis and patient counseling.
How similar studies have performed: Prior controlled exercise tests have repeatedly shown post-exertional malaise in ME/CFS compared with healthy controls or patients with multiple sclerosis, but direct comparisons with patients referred for cardiology exercise testing are novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Marseille
- Hôpital Européen Marseille — Marseille, France (Recruiting)
Study contacts
- Study coordinator: Myriam BENNANI
- Email: m.bennani@hopital-europeen.fr
- Phone: 0413428351
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.