Self-Management Program Based on Physical Exercises for People With Multiple Sclerosis With Mild Neurological Impairment: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Fatigue
研究概览
简要总结
Fatigue is the most chronic and disabling symptom in multiple sclerosis patients. Self-management physical exercise programs seem promising to allow patients to improve their fatigue and their deconditioning. However, the effectiveness of such programs has been poorly assessed until now. The objectives of the present study are to evaluate the relationships between fatigue and physical capacity among slightly affected MS patients, and to carry on a large trial to assess the effectiveness of a self-management exercise program in the same patients. Sixty-four patients will be included and will be asked, after an educational period, to perform at least three exercise sessions of more than 30 minutes each week, over a period of three months. Patients will be splitted in two groups : one group will perform endurance and resistance physical exercises, and the other one will perform relaxation exercises with the help of soothing music. A regular coaching will adapt the exercises and motivate the patients to continue the treatment. Assessors won't be informed of patients' treatment. Four evaluations will be done, and will notably assess muscle strength, endurance, fatigue and social participation.
详细描述
Objectives: the aims of this project are two-fold:
- The first aim is to evaluate the relationships between fatigue and physical capacity, among multiple sclerosis (MS) patients at the early stage of the disease and their relations to plasmatic cytokines levels;
- The second aim is to assess the effectiveness of a self-management program of physiotherapy, based on endurance and resistance physical exercises, in MS patients at the early stage of the disease.
Rationale and scientific background:
Multiple sclerosis affects one person per thousand people in France and Belgium. Two thousand patients are newly diagnosed in France each year. Fatigue is an early and very disabling symptom of MS, that affects 50 to 80% of MS patients. Fatigue is described by patients as the most chronic and the most disabling symptom and is associated with a decline in motivation and a need for rest. Fatigue can occur spontaneously or can be induced by physical or mental activity, acute infection, or ingestion of food. It can occur at any time but usually worsens along the day.
Fatigue can have multiple origins in patients with MS: brain lesion load, cortical atrophy, dysfunction of the hypothalamo-pituitary axis, depression or physical deconditioning. Several approaches seem promising to improve fatigue: energy conservation programs, which help patients in organizing their daily activities to avoid fatigue, cognitive behavioural therapy, medications and physical exercise. Patients with MS show indeed a degradation of their cardio-respiratory endurance. This degradation seems to occur early in the course of MS, and to be already present in patients with mild neurological impairments. A deconditioning is regularly found in patients complaining of fatigue. However, the literature does not provide clear information about the relationship between physical deconditioning and fatigue, at the very early stage of MS.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •A diagnosis of MS performed by a specialized neurologist (revised McDonald criteria, 2010), regardless of the form of the disease (relapsing-remitting, primary progressive, secondary progressive);
- •An EDSS score less than or equal to 3.5, with a functional score less than or equal to 2 for the pyramidal and cerebellar functions;
- •An age between 18 and 65 years.
排除标准
- •An affection of one or both lower limbs limiting their ability to walk;
- •Another illness contraindicating the practice of exercises (ACSM criteria, 2011);
- •An episode of relapse within the 4 weeks prior to inclusion;
- •Participation in a study targeting rehabilitation, within the 3 months prior to inclusion;
- •Modification of drug treatment of MS (disease-modifying treatment and symptomatic treatment) in the 3 months prior to inclusion;
- •Change in the physiotherapy prescription within the 3 months prior to inclusion.
- •Pregnancy
- •Participation in a regular exercise program at least 3 times a week for at least 30 minutes for more than 6 months.
结局指标
主要结局
Fatigue
时间窗: 28 days
Modified Fatigue Impact Scale (MFIS)
Change in fatigue
时间窗: Evaluation at baseline, one immediately after the intervention program, one 3 months afterward and the last one 6 months after the end of the intervention
MFIS
次要结局
- Change in plasmatic cytokines: TNFa(Baseline and immediately after the intervention)
- Change in walking capacity(2 evaluations at baseline, one immediately after the intervention program, one 3 months afterward and the last one 6 months after the end of the intervention)
- Change in static and dynamic balance(2 evaluations at baseline, one immediately after the intervention program, one 3 months afterward and the last one 6 months after the end of the intervention)
- Safety (Number of patients with adverse events related to treatment).(Through study completion, an average of 9 months)
- Change in Neurological Disability(2 evaluations at baseline, one immediately after the intervention program, one 3 months afterward and the last one 6 months after the end of the intervention)
- Change in plasmatic cytokines: IFNg(Baseline and immediately after the intervention)
- Change in Lower limbs spasticity(2 evaluations at baseline, one immediately after the intervention program, one 3 months afterward and the last one 6 months after the end of the intervention)
- Change in objective walking endurance(2 evaluations at baseline, one immediately after the intervention program, one 3 months afterward and the last one 6 months after the end of the intervention)
- Amount of physical activity performed(From the first day after the completion of the treatment, every 3 months up to 6 months.)
- Change in MS-specific health related quality of life(2 evaluations at baseline, one immediately after the intervention program, one 3 months afterward and the last one 6 months after the end of the intervention)
- Adherence(Weekly through the intervention (during 3 months))
- Change in Cardiorespiratory fitness(2 evaluations at baseline, one immediately after the intervention program, one 3 months afterward and the last one 6 months after the end of the intervention)
研究者
Lejeune
professeur
Cliniques universitaires Saint-Luc- Université Catholique de Louvain