Role of Individualized Versus Traditional Exercise in Combating Fatigue in Fatigued Multiple Sclerosis Patients
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Chronic fatigue score
研究概览
简要总结
The objective of this project will be to characterise the benefits of an exercise programme adapted to each individual's abilities compared to a traditional exercise programme with the aim of reducing perceived fatigue and improving the quality of life of Patients with multiple sclerosis.
详细描述
Chronic fatigue is a very common symptom reported (80%) by patients with multiple sclerosis (MS), regardless of the type of MS and level of disability. Despite the clinical importance of MS-related fatigue, pharmacological treatments remain quite ineffective in preventing or treating chronic fatigue.
Recently, physical activity has proven to be an effective therapy with benefits on chronic fatigue as well as on different functions (muscular, cardiorespiratory, cognitive, etc.). Nevertheless, the effects of physical exercise may vary between MS patients, as MS is a heterogeneous disease and does not affect each individual in the same way. The objective of this project will be to characterise the benefits of an exercise programme adapted to each individual's abilities compared to a traditional exercise programme with the aim of reducing perceived fatigue and improving the quality of life of Patients with multiple sclerosis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 18 to 70 years old
- •Male or female
- •With relapsing-remitting multiple sclerosis (RRMS) as defined by McDonald's 2010 criteria.
- •Between 2 and 25 years from the onset of multiple sclerosis
- •With a high level of fatigue, corresponding to a score of Fatigue Severity Scale> 4 and Fatigue questionnaire >
- •Expanded Disability Status Scale Score 5
- •Testing ≥ 4 in all leg muscles.
- •Ability to walk for 10 minutes without stopping (self-reported)
- •Affiliates or beneficiaries of a social security scheme
- •Having freely given their written consent after having been informed of the purpose, course of action and potential risks involved
排除标准
- •Severe cerebellar spasticity or ataxia in either leg.
- •Abnormal range of motion of the toes and/or ankle.
- •Musculoskeletal injury that interferes with pedaling.
- •High resting heart rate (>90 beats per minute).
- •Blood pressure > 144/94 mmHg.
- •Onset of a multiple sclerosis attack within 90 days prior to the study.
- •Recent adjustment of any medication or drugs that may impact on fatigue, or taking stimulants for fatigue (e.g. Modafinil).
- •Taking of neuro-active substances that may impair cortico-spinal excitability (hypnotics, antiepileptics, psychotropic drugs, muscle relaxants) throughout the study period.
- •Contraindication to the application of a magnetic field
- •History of co-morbid disease 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 within 30 days prior to this study.
- •Pregnant and Nursing Women
- •Women of childbearing age without effective contraception
- •Patient unable to understand the purpose and conditions of the study, incapable of giving consent
- •Patient deprived of liberty or patient under guardianship
研究组 & 干预措施
Traditional exercise
fatigued multiple sclerosis patients with a traditional training program
干预措施: traditional training program (Other)
Individual exercise
tired multiple sclerosis patients with an adapted and individualized training program
干预措施: Adapted and individualized physical training program (Other)
结局指标
主要结局
Chronic fatigue score
时间窗: Month 3
assessed using the Fatigue Severity Scale (FSS) questionnaire before and after an individualized re-training program compared to a traditional re-training program in MS patients.
次要结局
- Analysis overall quality of life : Fatigue questionnaire(Month 3)
- Analysis overall quality of life : Physical Activity(Month 3)
- Hematological parameters(Month 3)
- Inflammatory parameters(Month 3)
- quality of sleep(Month 3)
- cortical activation level(Month 3)
- neuromuscular fatigue of peripheral function(Month 3)
- cortico-spinal excitability(Month 3)
- cardiorespiratory fitness(Month 3)
- Analysis overall quality of life :Quality of Life(Month 3)
- Analysis overall quality of life :Depression(Month 3)
- Analysis overall quality of life : Sleep Quality(Month 3)