Effects of Individualized Training to Reduce Fatigue in Patients With Newly and Advanced Diagnose… (NCT06201026) | Clinical Trial Compass
RecruitingNot Applicable
Effects of Individualized Training to Reduce Fatigue in Patients With Newly and Advanced Diagnosed Multiple Sclerosis
France96 participantsStarted 2023-09-12
Plain-language 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.
Who can participate
Age range
18 Years – 60 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
*…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Fatigue Severity Scale (FSS)
Timeframe: Week 15
Trial details
NCT IDNCT06201026
SponsorCentre Hospitalier Universitaire de Saint Etienne