Actively Recruiting
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.
Led by Hôpital Européen Marseille · Updated on 2026-06-08
80
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to compare post-exertional symptom worsening in two groups: patients with Myalgic Encephalomyelitis / Chronic Fatigue Syndrome (ME/CFS) and patients with cardiac diseases who undergo an exercise test as part of routine care. ME/CFS is characterized by persistent fatigue along with pain, sleep problems, cognitive and autonomic symptoms, and muscle and digestive issues. A key feature is post-exertional malaise, meaning symptoms worsen after physical or mental effort. The study also investigates how muscle oxygen levels change during exercise using Near Infrared Spectroscopy (NIRS). Participants will take part in a standardized exercise test on a cycle ergometer. Muscle oxygenation will be monitored before, during, and after exercise using NIRS. Symptoms will be assessed with questionnaires before the test and over the following 7 days. Two groups are studied: ME/CFS patients diagnosed by international criteria, and cardiac patients referred for exercise tests due to symptoms like palpitations or chest pain, who also have moderate to severe fatigue. During the study, researchers will track the time it takes for symptoms to start after exercise and monitor how symptoms change over 7 days. They will also measure the duration and intensity of symptoms and record muscle oxygen levels. Participants must be able to use digital devices to complete online questionnaires. The study monitors these outcomes to better understand post-exertional symptom patterns in both patient groups, with the trial lasting up to 7 days after the exercise test.
CONDITIONS
Brief Title
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.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- For ME/CFS patients: Clinical diagnosis according to the International Consensus Criteria 2011
- For cardiac patients: Referred for an exercise test due to palpitations, hypertension, exertional dyspnea, chest pain, coronary artery disease, and moderate to severe fatigue (NRS > 3/10) in the last 8 days
- Ability to use a computer or digital device to complete online questionnaires
- Provided free and informed written consent
You will not qualify if you...
- Pregnant or breastfeeding women
- Persons deprived of liberty by judicial or administrative decision
- Persons under legal protection or unable to give consent
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 day for exercise test plus 7 days of symptom monitoring
Participants undergo a standardized exercise test on a cycle ergometer with muscle oxygenation monitored before, during, and after exercise. Symptoms are assessed using questionnaires before the test and during the 7 days following the exercise test.
1 exercise test visit and daily online questionnaires for 7 days
Trial Site Locations
Total: 1 location
1
Hôpital Européen Marseille
Marseille, France
Actively Recruiting
Research Team
M
Myriam BENNANI
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
OTHER
Number of Arms
2
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