Fatigue Syndrome, ChronicMAPEMCARNCT07491315
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.
A study testing Exercise test on ergocycle and Near Infrared Spectroscopy (NIRS) in people with Fatigue Syndrome, Chronic and Cardiovascular Diseases, run by Hôpital Européen Marseille at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Fatigue Syndrome, Chronic, Cardiovascular Diseases
- What is being tested?
- Exercise test on ergocycle and Near Infrared Spectroscopy (NIRS)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteFrance
- Study dates
- 24 Jun 2025to 24 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Hôpital Européen Marseille
Marseille
Myriam BENNANI, 0413428351, m.bennani@hopital-europeen.fr
Frédérique RETORNAZ
About this study
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.
Read more
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
- Being tested
- Exercise test on ergocycle, Near Infrared Spectroscopy (NIRS)
- Medical subject headings
- Fatigue Syndrome, Chronic, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise test on ergocycleOther
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.
Near Infrared Spectroscopy (NIRS)Other
Muscle oxygenation will be monitored using Near Infrared Spectroscopy (NIRS) before, during and after exercise
| Study group | Role | What they receive |
|---|---|---|
| Fatigue Syndrome, Chronic | Other | Not described Receives: Other: Exercise test on ergocycle; Other: Near Infrared Spectroscopy (NIRS) |
| Cardiovascular diseases | Other | Not described Receives: Other: Exercise test on ergocycle; Other: Near Infrared Spectroscopy (NIRS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Type of symptoms reported by participants after the exercise test.
Measured: From immediately after the exercise test up to Day 7.
Duration of symptoms after the exercise test in both groups.
Type of symptoms reported by participants after the exercise test.
Measured: From immediately after the exercise test up to Day 7.
Intensity of post-exercise symptoms measured in both groups.
Type of symptoms reported by participants after the exercise test.
Measured: From immediately after the exercise test up to Day 7.
Characterization of symptoms experienced before the exercise test in both groups.
Baseline symptom characterization using the DePaul Symptom Questionnaire - Post-Exertional Malaise (DSQ-PEM). The DSQ-PEM evaluates the frequency and severity of post-exertional malaise symptoms. A frequency score and a severity score ≥ 2 for at least one of items 1-5 are indicative of post-exertional malaise. For diagnostic classification, either item 7 or item 8 must be positive, and item 9 must indicate a duration of symptoms greater than 14 hours. Higher frequency and severity scores indicate greater symptom burden.
Measured: 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.
Measurement of changes in oxyhaemoglobin and deoxyhaemoglobin concentrations in muscle tissue using Near-Infrared Spectroscopy (NIRS).
Measured: Before, during, and up to 10 minutes after the exercise test.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2026
- Study start24 Jun 2025
- Primary completion24 Dec 2026 (estimated)
- Study completion24 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fatigue Syndrome, ChronicStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hôpital Européen Marseille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07491315
- Sponsor's protocol ID
- 24-30
- Acronym
- MAPEMCAR
- Status last verified
- Jun 2026
- First submitted
- 18 Mar 2026
- Last updated
- 8 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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.
- ClinicalTrials.gov ID
- NCT07491315
- Acronym / sponsor ID
- MAPEMCAR / 24-30
- Conditions
- Fatigue Syndrome, Chronic, Cardiovascular Diseases
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Hôpital Européen MarseilleUniversity, hospital or other
- Study start
- 24 Jun 2025 (actual)
- Primary completion
- 24 Dec 2026 (estimated)
- Study completion
- 24 Dec 2026 (estimated)
- First posted
- 24 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exercise test on ergocycleParticipants 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 | Cardiovascular diseases, Fatigue Syndrome, Chronic |
| Near Infrared Spectroscopy (NIRS)Muscle oxygenation will be monitored using Near Infrared Spectroscopy (NIRS) before, during and after exercise | Other | Cardiovascular diseases, Fatigue Syndrome, Chronic |
Primary outcome
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.
5 secondary outcomes
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.
Duration of symptoms after the exercise test in both groups.
Time frame: 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.
Characterization of symptoms experienced before the exercise test in both groups.
Time frame: 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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise test on ergocycle and Near Infrared Spectroscopy (NIRS) in people with Fatigue Syndrome, Chronic and Cardiovascular Diseases, run by Hôpital Européen Marseille at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Myriam BENNANI (0413428351, m.bennani@hopital-europeen.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jun 2026.