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Clinical Trial NCT07491315 (MAPEMCAR) for Fatigue Syndrome, Chronic, Cardiovascular Diseases is recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here. | ||
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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) 80 Exercise-Based
Clinical Trial NCT07491315 (MAPEMCAR) is an interventional study for Fatigue Syndrome, Chronic, Cardiovascular Diseases that is recruiting. It started on 24 June 2025 with plans to enroll 80 participants. Led by Hôpital Européen Marseille, it is expected to complete by 24 December 2026. The latest data from ClinicalTrials.gov was last updated on 24 March 2026.
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 ...Show More
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.
Conditions
Fatigue Syndrome, ChronicCardiovascular DiseasesOther Study IDs
- MAPEMCAR
- 24-30
NCT ID Number
Start Date (Actual)
2025-06-24
Last Update Posted
2026-03-24
Completion Date (Estimated)
2026-12-24
Enrollment (Estimated)
80
Study Type
Interventional
PHASE
N/A
Status
Recruiting
Primary Purpose
Other
Design Allocation
Non-Randomized
Interventional Model
Parallel
Masking
None (Open Label)
Arms / Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
OtherFatigue Syndrome, Chronic | 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. Near Infrared Spectroscopy (NIRS) Muscle oxygenation will be monitored using Near Infrared Spectroscopy (NIRS) before, during and after exercise |
OtherCardiovascular diseases | 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. Near Infrared Spectroscopy (NIRS) Muscle oxygenation will be monitored using Near Infrared Spectroscopy (NIRS) before, during and after exercise |
Primary Outcome Measures
Secondary 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. | Type of symptoms reported by participants after the exercise test. | From immediately after the exercise test up to Day 7. |
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
Symptoms observed during the 7 days following the exercise test in both groups | 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. | 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. | 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. | 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. | 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. |
Participation Assistant
Eligibility Criteria
Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
All
- 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
- 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.
Hôpital Européen MarseilleStudy Central Contact
Contact: Myriam BENNANI, 0413428351, [email protected]
1 Study Locations in 1 Countries
Hôpital Européen Marseille, Marseille, France
Myriam BENNANI, Contact, 0413428351, [email protected]
Frédérique RETORNAZ, Principal Investigator
Recruiting