Is Post-exertional Symptom Exacerbation Specific to Patients With Myalgic Encephalomyelitis / Chr… (NCT07491315) | Clinical Trial Compass
RecruitingNot Applicable
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.
France80 participantsStarted 2025-06-24
Plain-language summary
Myalgic Encephalomyelitis / Chronic Fatigue Syndrome (ME/CFS) is a disease characterized by persistent and unexplained fatigue associated with diffuse pain, sleep disorders, neurocognitive and autonomic symptoms, musculoskeletal manifestations and digestive symptoms. A central feature of this disease is post-exertional symptom exacerbation, also referred to as post-exertional malaise, defined as the worsening or the appearance of symptoms after physical or mental exertion, sometimes even minimal.
Several studies have described post-exertional malaise in populations of patients with ME/CFS following a standardized exercise test performed over one or two consecutive days. These studies confirmed the presence of post-exertional malaise in ME/CFS patients compared with healthy controls or patients with multiple sclerosis.
However, no data are available evaluating the impact of an exercise test on symptoms in patients referred to cardiology for this examination. Patients with cardiac diseases may also present symptoms such as fatigue, dyspnea or exercise intolerance.
This study aims to compare post-exertional symptoms in two populations: patients with ME/CFS and patients with cardiac diseases undergoing an exercise test as part of routine clinical evaluation. The study also aims to measure variations in muscle oxyhemoglobin and deoxyhemoglobin concentrations before, during and after exercise using Near Infrared Spectroscopy (NIRS).
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Time to onset of symptoms after completion of the exercise test on an ergocycle in both groups.
Timeframe: From immediately after the exercise test up to Day 7.