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 research is investigating whether the severe worsening of symptoms after even small amounts of effort, known as post-exertional malaise, is unique to people with Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS). It compares how people with ME/CFS and those with certain heart conditions react to an exercise test. Both groups can experience tiredness, breathlessness, and difficulty with exercise. The study aims to see if the symptoms after exercise, and changes in muscle oxygen levels measured by a special device, are different between these two groups. This could help us better understand the specific features of ME/CFS.
At a glance
What is this study about?
Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS) is a long-term illness where one of the main problems is feeling extremely tired and unwell after physical or mental activity, even if it's not very strenuous. This is called post-exertional malaise. Along with this, people often have widespread pain, sleep problems, difficulties with thinking, and other physical symptoms.
We know from previous studies that people with ME/CFS definitely experience this post-exertional malaise after doing a controlled exercise test. These studies have compared them to healthy people or those with other conditions like multiple sclerosis, confirming that ME/CFS patients react differently to exercise.
However, we don't know much about how exercise affects people who have heart conditions and are doing an exercise test as part of their routine check-ups. People with heart problems can also feel very tired, breathless, or find exercise difficult. This study wants to see if the extreme worsening of symptoms after exercise, which is so characteristic of ME/CFS, is truly specific to ME/CFS patients, or if it's also seen in a similar way in people with certain heart conditions. We'll also use a special light sensor on the muscle to see how oxygen levels change during and after exercise.
Key takeaways
- Compares ME/CFS and heart condition patients.
- Investigates extreme tiredness after exercise (post-exertional malaise).
- Uses a supervised exercise test and muscle oxygen measurements.
- Aims to understand ME/CFS better by comparing it to heart conditions.
- No new medications are given in this study.
Who may be eligible?
To join this study, you need to be 18 years old or older. If you have ME/CFS, your diagnosis must meet specific international guidelines. If you have a heart condition, you'll be considered if you're already scheduled for an exercise test for issues like palpitations, high blood pressure, breathlessness during activity, chest pain, or coronary artery disease.
For the heart condition group, you must also be experiencing moderate to severe tiredness (scoring more than 3 out of 10 on a tiredness scale) in the week before the study, and you shouldn't have an ME/CFS diagnosis. Everyone taking part needs to be able to use a computer or tablet to fill out questionnaires.
You cannot join the study if you are pregnant or breastfeeding. Also, anyone who is in legal custody or unable to give their own consent for medical studies will not be able to participate.
Could this study suit you?
Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.
- Are you 18 years old or older?
- If you have ME/CFS, is your diagnosis based on international standards (ICC 2011)?
- If you have a heart condition, are you already scheduled for an exercise test and experiencing moderate to severe tiredness?
- Can you use a computer or tablet to fill out questionnaires?
- Are you currently not pregnant or breastfeeding?
What does participation involve?
If you take part, you will first need to carefully read and sign a consent form. You will then complete some online questionnaires, likely using a computer or tablet. You will undergo a single exercise test on a stationary bike (ergocycle) in a hospital setting. During this test, a special light sensor (Near Infrared Spectroscopy or NIRS) will be placed on your muscle to measure oxygen levels before, during, and after you exercise. The total duration of your active involvement in the study will be focused around the exercise test and completing the questionnaires.
Potential risks and benefits
Locations (1)
- Hôpital Européen MarseilleVerified postcodeMarseille, France· Recruiting
Common questions
What is ME/CFS?
ME/CFS (Myalgic Encephalomyelitis/Chronic Fatigue Syndrome) is a long-term illness causing extreme tiredness that doesn't get better with rest, often worsened by activity, along with other symptoms like pain and sleep problems.
What is 'post-exertional malaise'?
It's a key symptom of ME/CFS where even small amounts of physical or mental effort can lead to a severe worsening of symptoms, sometimes lasting days or weeks.
What is an 'exercise test'?
It's a medical test, usually done on a stationary bike or treadmill, where you exercise under supervision while doctors monitor your heart and body's response.
What is NIRS?
NIRS (Near Infrared Spectroscopy) is a non-invasive device that uses light to measure how much oxygen is in your muscles before, during, and after exercise.
Will I get any medicine in this study?
No, this study does not involve giving any new medications. It focuses on tests and observations.
How to find out more
Myriam BENNANI
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
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