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Recruiting NCT06201026

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

No phase Interventional Sclerosis Fatigue

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Traditional exercise, Individualized exercise.
Who it may be relevant to
Registry conditions: Sclerosis, Fatigue. Basic parameters: 18 years — 60 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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.

Overview

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.

Detailed 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.

Interventions

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

Primary outcome measures

  • Fatigue Severity Scale (FSS) [Time frame: Week 15]
Secondary outcome measures (12)
  • cross sectional area (µm2) of type IIA fibers from the vastus lateralis muscle biopsies [Time frame: Week 17]
  • Muscle enzymatic activity (UI) [Time frame: Week 17]
  • Maximal oxygen uptake (VO2max) (ml/min) [Time frame: Week 15]
  • Percentage of voluntary activation (%) [Time frame: Week 16]
  • C-reactive protein (CRP) (mg/l) [Time frame: Week 15]
  • Maximal voluntary contraction (MVC) of the knee extensor muscle measurement [Time frame: Week 16]
  • Maximal voluntary contraction (MVC) of the hand grip measurement [Time frame: Week 16]
  • Balance test (s) [Time frame: Week 16]
  • Quality of life questionnaire (SEP-59) [Time frame: Week 15]
  • Epworth score [Time frame: Week 15]
  • Pittsburgh Sleep Quality Index (PSQI) [Time frame: Week 15]
  • Hospital Anxiety and Depression scale (HAD) [Time frame: Week 15]

Eligibility 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Supportive care

Study locations

France · 1 center
  • Chu de Saint-Etienne — Saint-Etienne

Identifiers

NCT: NCT06201026 · 23CH024 · ANSM

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗