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.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Time to onset of symptoms after completion of the exercise test on an ergocycle in both groups.
研究概览
简要总结
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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)
- •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
排除标准
- •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.
研究组 & 干预措施
Fatigue Syndrome, Chronic
干预措施: Exercise test on ergocycle (Other)
Fatigue Syndrome, Chronic
干预措施: Near Infrared Spectroscopy (NIRS) (Other)
Cardiovascular diseases
干预措施: Exercise test on ergocycle (Other)
Cardiovascular diseases
干预措施: Near Infrared Spectroscopy (NIRS) (Other)
结局指标
主要结局
Time to onset of symptoms after completion of the exercise test on an ergocycle in both groups.
时间窗: From immediately after the exercise test up to Day 7.
Type of symptoms reported by participants after the exercise test.
次要结局
- Characterization of symptoms experienced before the exercise test in both groups.(Day 0 (prior to the exercise test).)
- Symptoms observed during the 7 days following the exercise test in both groups(From immediately after the exercise test up to Day 7.)
- Duration of symptoms after the exercise test in both groups.(From immediately after the exercise test up to Day 7.)
- Intensity of post-exercise symptoms measured in both groups.(From immediately after the exercise test up to Day 7.)
- Variations in oxyhemoglobin and deoxyhemoglobin concentrations measured by Near Infrared Spectroscopy (NIRS) at the muscular level before, during and after exercise.(Before, during, and up to 10 minutes after the exercise test.)