Individualized training to reduce fatigue in multiple sclerosis patients
Effects of Individualized, Home-based, Mobile App-guided Training to Reduce Fatigue in Patients With Newly and Advanced Diagnosed Multiple Sclerosis: a Randomized Controlled Trial.
NA · Centre Hospitalier Universitaire de Saint Etienne · NCT06201026
This study is testing a personalized home exercise program using a mobile app to see if it can help people with multiple sclerosis feel less tired.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 96 (estimated) |
| Ages | 18 Years to 60 Years |
| Sex | All |
| Sponsor | Centre Hospitalier Universitaire de Saint Etienne (other) |
| Locations | 1 site (Saint-Etienne) |
| Trial ID | NCT06201026 on ClinicalTrials.gov |
What this trial studies
This study investigates the effects of a personalized home-training program, guided by a mobile application, aimed at reducing fatigue in patients with newly diagnosed and advanced multiple sclerosis (MS). Given that chronic fatigue is a prevalent symptom in MS patients, the study seeks to enhance the benefits of exercise therapy through tailored training, early initiation, and home practice. Participants will engage in traditional and individualized exercise regimens to improve their physical capacity and neuromuscular function.
Who should consider this trial
Good fit: Ideal candidates include individuals with relapsing-remitting MS diagnosed within the last two years or those with a longer history of MS but with recent symptoms, who experience high levels of fatigue.
Not a fit: Patients with severe spasticity, cerebellar ataxia, or musculoskeletal injuries that impair exercise may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly alleviate fatigue in MS patients, improving their overall quality of life.
How similar studies have performed: Previous studies have shown that personalized exercise programs can improve fatigue and physical function in MS patients, suggesting a promising approach.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Saint-Etienne
- Chu de Saint-Etienne — Saint-Etienne, France (RECRUITING)
Study contacts
- Principal investigator: Jean-Philippe CAMDESSANCHE, PHD — CHU DE SAINT-ETIENNE
- Study coordinator: Jean-Philippe CAMDESSANCHE, PHD
- Email: j.phillippe.camdessanche@chu-st-etienne.fr
- Phone: (4)77120559
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Sclerosis, Fatigue, Neuromuscular function, Muscle characteristics, Physical capacity