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. (MAPEMCAR)

Hôpital Européen Marseille

Status

Enrolling

Conditions

Fatigue Syndrome, Chronic

Cardiovascular Diseases

Treatments

Other: Near Infrared Spectroscopy (NIRS)

Other: Exercise test on ergocycle

Study type

Interventional

Funder types

Other

Identifiers

NCT07491315

24-30

Details and patient eligibility

About

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).

Enrollment

80 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

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.