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

N/ARecruitingNCT06201026

Centre Hospitalier Universitaire de Saint Etienne96 enrolled

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

Conditions

Sclerosis Fatigue

Interventions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 60 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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

Time frame: Week 15

Secondary Outcomes

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

ONLY FOR MS-N PATIENTS

Time frame: Week 17

Muscle enzymatic activity (UI)

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.

Time frame: Week 17

Maximal oxygen uptake (VO2max) (ml/min)

Cardiac stress test

Time frame: Week 15

Percentage of voluntary activation (%)

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

Time frame: Week 16

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

Blood sample

Time frame: Week 15

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

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

Time frame: Week 16

Maximal voluntary contraction (MVC) of the hand grip measurement

Time frame: Week 16

Balance test (s)

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.

Time frame: Week 16

Quality of life questionnaire (SEP-59)

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

Time frame: Week 15

Epworth score

From 0 to 24 The higher the score, the greater the degree of drowsiness

Time frame: Week 15

Pittsburgh Sleep Quality Index (PSQI)

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

Time frame: Week 15

Hospital Anxiety and Depression scale (HAD)

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

Time frame: Week 15

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

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts