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NCT Number: NCT06201026

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

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.

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Key information

Conditions

Sclerosis Fatigue Pathologic Processes Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Chu de Saint-Etienne

Saint-Etienne, 42055, France

Location status: Recruiting

Location contact

JEAN-PHILIPPE CAMDESSANCHE, PHD

CONTACT

[email protected]

(4)77120559

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

traditional exercise

Other

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

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.

Primary outcomes

  1. Fatigue Severity Scale (FSS)

    Time frame: Week 15

    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

Secondary outcomes

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

    Time frame: Week 17

    ONLY FOR MS-N PATIENTS

  2. Muscle enzymatic activity (UI)

    Time frame: Week 17

    ONLY FOR MS-N PATIENTS

    The enzymatic activity is measured for the following enzymes :

    • Phosphofructokinase (PFK)
    • lactate dehydrogenase (LDH)
    • citrate synthase (CS)
    • cyclo-oxygenase (COx)

    Enzymatic activity is measured in units international (UI) It indicates the rate of enzymatic reaction catalyzed by the enzyme, expressed in micromoles of substrate transformed (or product formed) per minute.

  3. Maximal oxygen uptake (VO2max) (ml/min)

    Time frame: Week 15

    Cardiac stress test

  4. Percentage of voluntary activation (%)

    Time frame: Week 16

    Voluntary Activation of the extensor muscles of the knee by peripheral nerve stimulation

  5. C-reactive protein (CRP) (mg/l)

    Time frame: Week 15

    Blood sample

  6. Maximal voluntary contraction (MVC) of the knee extensor muscle measurement

    Time frame: Week 16

    Maximal isometric force (maximal voluntary contraction, MVC) of the knee extensor muscle

  7. Maximal voluntary contraction (MVC) of the hand grip measurement

    Time frame: Week 16

  8. Balance test (s)

    Time frame: Week 16

    This test, performed in unipedal support, consists of asking the subject to hold the unipedal position for as long as possible, on the lower limb of his choice.

  9. Quality of life questionnaire (SEP-59)

    Time frame: Week 15

    Scale from 0 (worst quality of life) to 100 (best quality of life)

  10. Epworth score

    Time frame: Week 15

    From 0 to 24

    The higher the score, the greater the degree of drowsiness

  11. Pittsburgh Sleep Quality Index (PSQI)

    Time frame: Week 15

    From 0 to 21 The higher the score, the worse the quality of sleep

  12. Hospital Anxiety and Depression scale (HAD)

    Time frame: Week 15

    From 0 to 42 The higher the score, the greater the anxiety and depression

Study contacts

Contact information is provided by the study sponsor or research team.

Jean-Philippe CAMDESSANCHE, PHD

CONTACT

[email protected]

(4)77120559 ext. +33

Leonard FEASSON, PHD

CONTACT

[email protected]

(4)77120559 ext. +33

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Saint Etienne

Other

Registry information

Official study 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.

Acronym: MovelySEP

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Jan 11, 2024
Registry last updated
Oct 23, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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