NCT06201026 Effects of Individualized Training to Reduce Fatigue in Patients With Newly and Advanced Diagnosed Multiple Sclerosis
| NCT ID | NCT06201026 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Centre Hospitalier Universitaire de Saint Etienne |
| Condition | Sclerosis |
| Study Type | INTERVENTIONAL |
| Enrollment | 96 participants |
| Start Date | 2023-09-12 |
| Primary Completion | 2025-07-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 96 participants in total. It began in 2023-09-12 with a primary completion date of 2025-07-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Multiple sclerosis (MS) is a chronic autoimmune inflammatory disease of the central nervous system. It is characterized by complex and heterogeneous symptoms. Chronic fatigue is the most reported symptom in MS patients (80%). Current pharmacological treatments for MS patients reduce the number of relapses and their severity but do not improve symptoms such as fatigue. Physical activity is a therapy that helps reduce this fatigue, in addition to improving muscular and cardiorespiratory functions. However, the results are not optimal because MS patients remain less active than the general population. The improvement of the benefits of exercise therapy could therefore be based on three approaches: personalization of the training program, home practice and early initiation.
Eligibility Criteria
Inclusion criteria * Relapsing-remitting MS (RRMS) defined according to the criteria of McDonald * MS diagnosed less than 2 years ago or whose first symptoms are estimated to be less than 5 years old OR MS diagnosed more than 2 years ago and whose first symptoms are estimated to be less than 5 years old * With a high level of fatigue, corresponding to an FSS score \> 4 * Expanded Disability Status Scale (EDSS) score \< 4 * Medical Research Council (MRC) testing ≥ 4 in all leg muscles * Ability to walk for 10 minutes without stopping (self-reported) * Have a mobile phone with internet access * Affiliated with or benefiting from a social security scheme * Have freely given their written consent after being informed of the aim, the procedure and the potential risks involved Exclusion criteria * Spasticity or severe cerebellar ataxia in either leg. * Abnormal range of movement of the toes and/or ankle * Musculoskeletal injury that impairs pedalling * Appearance of a multiple sclerosis attack in the 90 days preceding the study * Recent adjustment of any medication or drug that may have an impact on fatigue: treatment of neuropathic pain: anti-epileptic and/or taking stimulants for fatigue (e.g. modafinil, amantadine, fampridine...) * History of comorbid illness or conditions that would compromise the subject's safety during the study * Participation at the same time in another medical intervention study or having participated in such a study in the 30 days prior to this study * Pregnant and breast-feeding women * Patients who are unable to understand the purpose of the study and the conditions under which it will be conducted, or who are unable to give their consent. * Patients deprived of their liberty or under guardianship
Contact & Investigator
Jean-Philippe CAMDESSANCHE, PHD
PRINCIPAL INVESTIGATOR
CHU DE SAINT-ETIENNE
Frequently Asked Questions
Who can join the NCT06201026 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 60 Years, studying Sclerosis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06201026 currently recruiting?
Yes, NCT06201026 is actively recruiting participants. Contact the research team at j.phillippe.camdessanche@chu-st-etienne.fr for enrollment information.
Where is the NCT06201026 trial being conducted?
This trial is being conducted at Saint-Etienne, France.
Who is sponsoring the NCT06201026 clinical trial?
NCT06201026 is sponsored by Centre Hospitalier Universitaire de Saint Etienne. The principal investigator is Jean-Philippe CAMDESSANCHE, PHD at CHU DE SAINT-ETIENNE. The trial plans to enroll 96 participants.