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.

Обзор

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).

Вмешательства

• Другое Exercise test on ergocycle
  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.
• Другое Near Infrared Spectroscopy (NIRS)
  Muscle oxygenation will be monitored using Near Infrared Spectroscopy (NIRS) before, during and after exercise

Первичные конечные точки

• Time to onset of symptoms after completion of the exercise test on an ergocycle in both groups. [Срок оценки: From immediately after the exercise test up to Day 7.]

Вторичные конечные точки (5)

• Symptoms observed during the 7 days following the exercise test in both groups [Срок оценки: From immediately after the exercise test up to Day 7.]
• Duration of symptoms after the exercise test in both groups. [Срок оценки: From immediately after the exercise test up to Day 7.]
• Intensity of post-exercise symptoms measured in both groups. [Срок оценки: From immediately after the exercise test up to Day 7.]
• Characterization of symptoms experienced before the exercise test in both groups. [Срок оценки: 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. [Срок оценки: Before, during, and up to 10 minutes after the exercise test.]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Нерандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Другое

Центры проведения

Франция · 1 центр

• Hôpital Européen Marseille — Marseille

Идентификаторы

NCT: NCT07491315 · 24-30

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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