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.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 96
- 试验地点
- 1
- 主要终点
- Fatigue Severity Scale (FSS)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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.
干预措施: 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
干预措施: 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
干预措施: 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
干预措施: Traditional exercise (Other)
结局指标
主要结局
Fatigue Severity Scale (FSS)
时间窗: 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
次要结局
- 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)