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

Официальное название

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.

Обзор

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.

Подробное описание

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.

Вмешательства

• Другое Traditional exercise
  Patients will perform aerobic and resistance exercises that are consistent with the exercise guidelines for MS patients at home
• Другое Individualized exercise
  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.

Первичные конечные точки

• Fatigue Severity Scale (FSS) [Срок оценки: Week 15]

Вторичные конечные точки (12)

• cross sectional area (µm2) of type IIA fibers from the vastus lateralis muscle biopsies [Срок оценки: Week 17]
• Muscle enzymatic activity (UI) [Срок оценки: Week 17]
• Maximal oxygen uptake (VO2max) (ml/min) [Срок оценки: Week 15]
• Percentage of voluntary activation (%) [Срок оценки: Week 16]
• C-reactive protein (CRP) (mg/l) [Срок оценки: Week 15]
• Maximal voluntary contraction (MVC) of the knee extensor muscle measurement [Срок оценки: Week 16]
• Maximal voluntary contraction (MVC) of the hand grip measurement [Срок оценки: Week 16]
• Balance test (s) [Срок оценки: Week 16]
• Quality of life questionnaire (SEP-59) [Срок оценки: Week 15]
• Epworth score [Срок оценки: Week 15]
• Pittsburgh Sleep Quality Index (PSQI) [Срок оценки: Week 15]
• Hospital Anxiety and Depression scale (HAD) [Срок оценки: Week 15]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Поддерживающая терапия

Центры проведения

Франция · 1 центр

• Chu de Saint-Etienne — Saint-Etienne

Идентификаторы

NCT: NCT06201026 · 23CH024 · ANSM

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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