Hôpital Européen Marseille
Marseille, France
Location status: Recruiting
NCT Number: NCT07491315
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).
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
Marseille, France
Location status: Recruiting
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Muscle oxygenation will be monitored using Near Infrared Spectroscopy (NIRS) before, during and after exercise
Time frame: From immediately after the exercise test up to Day 7.
Type of symptoms reported by participants after the exercise test.
Time frame: From immediately after the exercise test up to Day 7.
Type of symptoms reported by participants after the exercise test.
Time frame: From immediately after the exercise test up to Day 7.
Type of symptoms reported by participants after the exercise test.
Time frame: From immediately after the exercise test up to Day 7.
Type of symptoms reported by participants after the exercise test.
Time frame: Day 0 (prior to the exercise test).
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.
Time frame: Before, during, and up to 10 minutes after the exercise test.
Measurement of changes in oxyhaemoglobin and deoxyhaemoglobin concentrations in muscle tissue using Near-Infrared Spectroscopy (NIRS).
Contact information is provided by the study sponsor or research team.
Hôpital Européen Marseille
Other
Acronym: MAPEMCAR
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