Sclerosis, Fatigue
Conditions
Keywords
Fatigue, Neuromuscular function, Muscle characteristics, Physical capacity
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.
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
OTHERTraditional exercise
Patients will perform aerobic and resistance exercises that are consistent with the exercise guidelines for MS patients at home
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.
Sponsors
Centre Hospitalier Universitaire de Saint Etienne
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Fatigue Severity Scale (FSS) | 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
| Measure | Time frame | Description |
|---|---|---|
| Muscle enzymatic activity (UI) | 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. |
| Maximal oxygen uptake (VO2max) (ml/min) | Week 15 | Cardiac stress test |
| Percentage of voluntary activation (%) | Week 16 | Voluntary Activation of the extensor muscles of the knee by peripheral nerve stimulation |
| C-reactive protein (CRP) (mg/l) | Week 15 | Blood sample |
| Maximal voluntary contraction (MVC) of the knee extensor muscle measurement | Week 16 | Maximal isometric force (maximal voluntary contraction, MVC) of the knee extensor muscle |
| cross sectional area (µm2) of type IIA fibers from the vastus lateralis muscle biopsies | Week 17 | ONLY FOR MS-N PATIENTS |
| Balance test (s) | 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. |
| Quality of life questionnaire (SEP-59) | Week 15 | Scale from 0 (worst quality of life) to 100 (best quality of life) |
| Epworth score | Week 15 | From 0 to 24 The higher the score, the greater the degree of drowsiness |
| Pittsburgh Sleep Quality Index (PSQI) | Week 15 | From 0 to 21 The higher the score, the worse the quality of sleep |
| Hospital Anxiety and Depression scale (HAD) | Week 15 | From 0 to 42 The higher the score, the greater the anxiety and depression |
| Maximal voluntary contraction (MVC) of the hand grip measurement | Week 16 | — |
Countries
France
Contacts
Primary ContactJean-Philippe CAMDESSANCHE, PHD
Backup ContactLeonard FEASSON, PHD
Outcome results
None listed