Effects of Individualized Training to Reduce Fatigue in Patients With Newly and Advanced Diagnosed Multiple Sclerosis (MovelySEP)

Centre Hospitalier Universitaire de Saint Etienne

Status: Enrolling

Conditions: Sclerosis; Fatigue

Treatments: Other: Traditional exercise; Other: Individualized exercise

Study type: Interventional

Funder types: Other

Identifiers

NCT06201026

23CH024

ANSM (Other Identifier)

Details and patient eligibility

About

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.

Full description

The objective of this study will be to investigate the effects of individualized home-training, guided by a mobile application, to reduce fatigue in patients with newly (N) and advanced (A) diagnosed MS.

Enrollment: 96 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion and 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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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96 participants in 4 patient groups

Traditional exercise group in newly diagnosed patients with MS (SEP-R-TEM)

Active Comparator group

Description:

Newly diagnosed patients with MS who will be part of the group doing traditional exercises

Treatment:

Other: Traditional exercise

Individualized exercise group in newly diagnosed patients with MS (SEP-R-IND)

Experimental group

Description:

Newly diagnosed patients with MS who will be part of the group doing individualized exercises

Treatment:

Other: Individualized exercise

Traditional exercise group in advanced diagnosed patients with MS (SEP-A-TEM)

Active Comparator group

Description:

Advanced diagnosed patients with MS who will be part of the group doing traditional exercises

Treatment:

Other: Traditional exercise

Individualized exercise group in advanced diagnosed patients with MS (SEP-A-IND)

Experimental group

Description:

Advanced diagnosed patients with MS who will be part of the group doing individualized exercises.

Treatment:

Other: Individualized exercise