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)

March 18, 2026 updated by: Hôpital Européen Marseille

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).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
      • Marseille, France
        • Recruiting
        • Hôpital Européen Marseille
        • Principal Investigator:
          • Frédérique RETORNAZ
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Fatigue Syndrome, Chronic
Other: 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.
Other: Near Infrared Spectroscopy (NIRS)
Muscle oxygenation will be monitored using Near Infrared Spectroscopy (NIRS) before, during and after exercise
Other: Cardiovascular diseases
Other: 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.
Other: Near Infrared Spectroscopy (NIRS)
Muscle oxygenation will be monitored using Near Infrared Spectroscopy (NIRS) before, during and after exercise

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to onset of symptoms after completion of the exercise test on an ergocycle in both groups.
Time Frame: From immediately after the exercise test up to Day 7.
Type of symptoms reported by participants after the exercise test.
From immediately after the exercise test up to Day 7.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Symptoms observed during the 7 days following the exercise test in both groups
Time Frame: From immediately after the exercise test up to Day 7.
Type of symptoms reported by participants after the exercise test.
From immediately after the exercise test up to Day 7.
Duration of symptoms after the exercise test in both groups.
Time Frame: From immediately after the exercise test up to Day 7.
Type of symptoms reported by participants after the exercise test.
From immediately after the exercise test up to Day 7.
Intensity of post-exercise symptoms measured in both groups.
Time Frame: From immediately after the exercise test up to Day 7.
Type of symptoms reported by participants after the exercise test.
From immediately after the exercise test up to Day 7.
Characterization of symptoms experienced before the exercise test in both groups.
Time Frame: Day 0 (prior to the exercise test).
Baseline characterization of symptoms using the DePaul Symptom Questionnaire (DSQ) completed by participants before the exercise test.
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.
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).
Before, during, and up to 10 minutes after the exercise test.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hôpital Européen Marseille

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 24, 2025

Primary Completion (Estimated)

December 24, 2026

Study Completion (Estimated)

December 24, 2026

Study Registration Dates

First Submitted

March 18, 2026

First Submitted That Met QC Criteria

March 18, 2026

First Posted (Actual)

March 24, 2026

Study Record Updates

Last Update Posted (Actual)

March 24, 2026

Last Update Submitted That Met QC Criteria

March 18, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 24-30

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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