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

NCT06201026 | Recruiting

• 2 other identifiers: 23CH024ANSM
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Sclerosis; Fatigue

Keywords

Fatigue; Neuromuscular function; Muscle characteristics; Physical capacity

Outcome Measures

Primary Outcomes (1)

• Fatigue Severity Scale (FSS)

  Change in the chronic fatigue score assessed using the FSS questionnaire before and after the training programme. From 1 to 7. The higher the score, the greater the fatigue

  Week 15

Secondary Outcomes (12)

• cross sectional area (µm2) of type IIA fibers from the vastus lateralis muscle biopsies

  Week 17

• Muscle enzymatic activity (UI)

  Week 17

• Maximal oxygen uptake (VO2max) (ml/min)

  Week 15

• Percentage of voluntary activation (%)

  Week 16

• C-reactive protein (CRP) (mg/l)

  Week 15

Study Arms (4)

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

ACTIVE COMPARATOR

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

Other: Traditional exercise

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

EXPERIMENTAL

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

Other: Individualized exercise

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

ACTIVE COMPARATOR

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

Other: Traditional exercise

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

EXPERIMENTAL

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

Other: Individualized exercise

Interventions

Traditional exercise OTHER

Patients will perform aerobic and resistance exercises that are consistent with the exercise guidelines for MS patients at home

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

Individualized exercise OTHER

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.

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

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Saint Etienne: lead

Study Sites (1)

Chu de Saint-Etienne

Saint-Etienne, 42055, France

RECRUITING

MeSH Terms

Conditions

Sclerosis; Fatigue

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms

Study Officials

• Jean-Philippe CAMDESSANCHE, PHD

  CHU DE SAINT-ETIENNE

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jean-Philippe CAMDESSANCHE, PHD

CONTACT

(4)77120559; j.phillippe.camdessanche@chu-st-etienne.fr

Leonard FEASSON, PHD

CONTACT

(4)77120559; leonard.feasson@chu-st-etienne.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 12, 2023
• First Posted: January 11, 2024
• Study Start: September 12, 2023
• Primary Completion: July 1, 2025
• Study Completion: September 15, 2025
• Last Updated: October 23, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)