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.

NCT07491315 | Recruiting

• 1 other identifier: 24-30
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Fatigue Syndrome, Chronic; Cardiovascular Diseases

Outcome Measures

Primary Outcomes (1)

• 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.

Secondary Outcomes (5)

• 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.

• Characterization of symptoms experienced before the exercise test in both groups.

  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.

  Before, during, and up to 10 minutes after the exercise test.

Study Arms (2)

Fatigue Syndrome, Chronic

OTHER

Other: Exercise test on ergocycle; Other: Near Infrared Spectroscopy (NIRS)

Cardiovascular diseases

OTHER

Other: Exercise test on ergocycle; Other: Near Infrared Spectroscopy (NIRS)

Interventions

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.

Cardiovascular diseases; Fatigue Syndrome, Chronic

Near Infrared Spectroscopy (NIRS) OTHER

Muscle oxygenation will be monitored using Near Infrared Spectroscopy (NIRS) before, during and after exercise

Cardiovascular diseases; Fatigue Syndrome, Chronic

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hôpital Européen Marseille: lead

Study Sites (1)

Hôpital Européen Marseille

Marseille, France

RECRUITING

MeSH Terms

Conditions

Fatigue Syndrome, Chronic; Cardiovascular Diseases

Interventions

Spectroscopy, Near-Infrared

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Encephalomyelitis; Neuroinflammatory Diseases; Nervous System Diseases; Neuromuscular Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques

Central Study Contacts

Myriam BENNANI

CONTACT

0413428351; m.bennani@hopital-europeen.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 18, 2026
• First Posted: March 24, 2026
• Study Start: June 24, 2025
• Primary Completion (Estimated): December 24, 2026
• Study Completion (Estimated): December 24, 2026
• Last Updated: June 8, 2026

Record last verified: 2026-06

Locations

FR (1)