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.

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 60
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
France
Chu de Saint-Etienne
RECRUITING
Saint-etienne
Contact Information
Primary
Jean-Philippe CAMDESSANCHE, PHD
j.phillippe.camdessanche@chu-st-etienne.fr
(4)77120559
Backup
Leonard FEASSON, PHD
leonard.feasson@chu-st-etienne.fr
(4)77120559
Time Frame
Start Date: 2023-09-12
Estimated Completion Date: 2025-09-15
Participants
Target number of participants: 96
Treatments
Active_comparator: Traditional exercise group in newly diagnosed patients with MS (SEP-R-TEM)
Newly diagnosed patients with MS who will be part of the group doing traditional exercises
Experimental: Individualized exercise group in newly diagnosed patients with MS (SEP-R-IND)
Newly diagnosed patients with MS who will be part of the group doing individualized exercises
Active_comparator: Traditional exercise group in advanced diagnosed patients with MS (SEP-A-TEM)
Advanced diagnosed patients with MS who will be part of the group doing traditional exercises
Experimental: Individualized exercise group in advanced diagnosed patients with MS (SEP-A-IND)
Advanced diagnosed patients with MS who will be part of the group doing individualized exercises.
Related Therapeutic Areas
Sponsors
Leads: Centre Hospitalier Universitaire de Saint Etienne

This content was sourced from clinicaltrials.gov