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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fatigue Syndrome, Chronic | Other |
| |
| Cardiovascular diseases | Other |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Exercise test on ergocycle | Other | Participants will undergo a standardized exercise test performed on a cycle ergometer. Symptoms will be assessed using questionnaires before the test and during the 7 days following the exercise test. |
| Measure | Description | Time Frame |
|---|---|---|
| Time to onset of symptoms after completion of the exercise test on an ergocycle in both groups. | Type of symptoms reported by participants after the exercise test. | From immediately after the exercise test up to Day 7. |
| Measure | Description | Time Frame |
|---|---|---|
| Symptoms observed during the 7 days following the exercise test in both groups | Type of symptoms reported by participants after the exercise test. | From immediately after the exercise test up to Day 7. |
| Duration of symptoms after the exercise test in both groups. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Myriam BENNANI | Contact | 0413428351 | m.bennani@hopital-europeen.fr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hôpital Européen Marseille | Recruiting | Marseille | France |
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| Near Infrared Spectroscopy (NIRS) | Other | Muscle oxygenation will be monitored using Near Infrared Spectroscopy (NIRS) before, during and after exercise |
|
Type of symptoms reported by participants after the exercise test. |
| From immediately after the exercise test up to Day 7. |
| Intensity of post-exercise symptoms measured in both groups. | Type of symptoms reported by participants after the exercise test. | From immediately after the exercise test up to Day 7. |
| Characterization of symptoms experienced before the exercise test in both groups. | Baseline symptom characterization using the DePaul Symptom Questionnaire - Post-Exertional Malaise (DSQ-PEM). The DSQ-PEM evaluates the frequency and severity of post-exertional malaise symptoms. A frequency score and a severity score ≥ 2 for at least one of items 1-5 are indicative of post-exertional malaise. For diagnostic classification, either item 7 or item 8 must be positive, and item 9 must indicate a duration of symptoms greater than 14 hours. Higher frequency and severity scores indicate greater symptom burden. | Day 0 (prior to the exercise test). |
| Variations in oxyhemoglobin and deoxyhemoglobin concentrations measured by Near Infrared Spectroscopy (NIRS) at the muscular level before, during and after exercise. | Measurement of changes in oxyhaemoglobin and deoxyhaemoglobin concentrations in muscle tissue using Near-Infrared Spectroscopy (NIRS). | Before, during, and up to 10 minutes after the exercise test. |
| ID | Term |
|---|---|
| D015673 | Fatigue Syndrome, Chronic |
| D002318 | Cardiovascular Diseases |
| ID | Term |
|---|---|
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D004679 | Encephalomyelitis |
| D000090862 | Neuroinflammatory Diseases |
| D009422 | Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D019265 | Spectroscopy, Near-Infrared |
| ID | Term |
|---|---|
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D013057 | Spectrum Analysis |
| D002623 | Chemistry Techniques, Analytical |
| D008919 | Investigative Techniques |
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