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.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 96
- Locations
- 1
- Primary Endpoint
- Fatigue Severity Scale (FSS)
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 60 Years (Adult)
- Sex
- All
- Accepts 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
Arms & Interventions
Individualized exercise group in advanced diagnosed patients with MS (SEP-A-IND)
Advanced diagnosed patients with MS who will be part of the group doing individualized exercises.
Intervention: Individualized exercise (Other)
Traditional exercise group in newly diagnosed patients with MS (SEP-R-TEM)
Newly diagnosed patients with MS who will be part of the group doing traditional exercises
Intervention: Traditional exercise (Other)
Individualized exercise group in newly diagnosed patients with MS (SEP-R-IND)
Newly diagnosed patients with MS who will be part of the group doing individualized exercises
Intervention: Individualized exercise (Other)
Traditional exercise group in advanced diagnosed patients with MS (SEP-A-TEM)
Advanced diagnosed patients with MS who will be part of the group doing traditional exercises
Intervention: Traditional exercise (Other)
Outcomes
Primary Outcomes
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
- Maximal oxygen uptake (VO2max) (ml/min)(Week 15)
- Muscle enzymatic activity (UI)(Week 17)
- Percentage of voluntary activation (%)(Week 16)
- Maximal voluntary contraction (MVC) of the knee extensor muscle measurement(Week 16)
- Epworth score(Week 15)
- cross sectional area (µm2) of type IIA fibers from the vastus lateralis muscle biopsies(Week 17)
- C-reactive protein (CRP) (mg/l)(Week 15)
- Maximal voluntary contraction (MVC) of the hand grip measurement(Week 16)
- Quality of life questionnaire (SEP-59)(Week 15)
- Balance test (s)(Week 16)
- Pittsburgh Sleep Quality Index (PSQI)(Week 15)
- Hospital Anxiety and Depression scale (HAD)(Week 15)