Clinical trial NCT06201026: Effects of Individualized Training to Reduce Fatigue in Patients With Newly and Advanced Diagnosed Multiple Sclerosis
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.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Sclerosis
Fatigue
Keywords: Fatigue
Neuromuscular function
Muscle characteristics
Physical capacity
Lead sponsor: Centre Hospitalier Universitaire de Saint Etienne
Sponsor class: OTHER
First posted: 2024-01-11
Enrollment: 96
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Fatigue Severity Scale (FSS)
timeFrame: Week 15
Secondary outcomes:
measure: cross sectional area (µm2) of type IIA fibers from the vastus lateralis muscle biopsies
timeFrame: Week 17
measure: Muscle enzymatic activity (UI)
timeFrame: Week 17
measure: Maximal oxygen uptake (VO2max) (ml/min)
timeFrame: Week 15
measure: Percentage of voluntary activation (%)
timeFrame: Week 16
measure: C-reactive protein (CRP) (mg/l)
timeFrame: Week 15
measure: Maximal voluntary contraction (MVC) of the knee extensor muscle measurement
timeFrame: Week 16
measure: Maximal voluntary contraction (MVC) of the hand grip measurement
timeFrame: Week 16
measure: Balance test (s)
timeFrame: Week 16
measure: Quality of life questionnaire (SEP-59)
timeFrame: Week 15
measure: Epworth score
timeFrame: Week 15
measure: Pittsburgh Sleep Quality Index (PSQI)
timeFrame: Week 15
measure: Hospital Anxiety and Depression scale (HAD)
timeFrame: Week 15
Other outcomes:
Locations:
city: Saint-Étienne
country: France
facility: Chu de Saint-Etienne
Study officials:
affiliation: CHU DE SAINT-ETIENNE
name: Jean-Philippe CAMDESSANCHE, PHD
role: PRINCIPAL_INVESTIGATOR
References: