Effects of Individualized Training to Reduce Fatigue in Patients With Newly and Advanced Diagnosed Multiple Sclerosis
NCT ID: NCT06201026
Last Updated: 2024-10-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
96 participants
INTERVENTIONAL
2023-09-12
2025-09-15
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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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
Traditional exercise
Patients will perform aerobic and resistance exercises that are consistent with the exercise guidelines for MS patients at home
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
Individualized exercise
Patients will performed a mobile-app guided program at home designed to address identified individual disabilities such as loss of muscle strength or cardiorespiratory deconditioning.
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
Traditional exercise
Patients will perform aerobic and resistance exercises that are consistent with the exercise guidelines for MS patients at home
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.
Individualized exercise
Patients will performed a mobile-app guided program at home designed to address identified individual disabilities such as loss of muscle strength or cardiorespiratory deconditioning.
Interventions
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Traditional exercise
Patients will perform aerobic and resistance exercises that are consistent with the exercise guidelines for MS patients at home
Individualized exercise
Patients will performed a mobile-app guided program at home designed to address identified individual disabilities such as loss of muscle strength or cardiorespiratory deconditioning.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
60 Years
ALL
No
Sponsors
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Centre Hospitalier Universitaire de Saint Etienne
OTHER
Responsible Party
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Principal Investigators
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Jean-Philippe CAMDESSANCHE, PHD
Role: PRINCIPAL_INVESTIGATOR
CHU DE SAINT-ETIENNE
Locations
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Chu de Saint-Etienne
Saint-Etienne, , France
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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ANSM
Identifier Type: OTHER
Identifier Source: secondary_id
23CH024
Identifier Type: -
Identifier Source: org_study_id
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