Preventing the Progression of Physical Disability and Promoting Brain Functional Adaptation in People With Multiple Sclerosis: Integration of Early Rehabilitative Treatment and Multimodal Clinical and Instrumental Assessment - Part B
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 80
- 试验地点
- 3
- 主要终点
- Fatigue Severity Scale (FSS)
研究概览
简要总结
It is widely recognized that physical exercise is safe and people with moderate Multiple Sclerosis (MS) are encouraged to train regularly to improve their skills in motor task execution. Several studies demonstrated that these activities represent an effective low-cost therapy which leads to significant and clinically meaningful improvements in gait and balance in people with MS (PwMS) with mild to moderate walking dysfunction, possibly also by promoting brain plasticity.
There is general agreement within the scientific community on the importance of timing intervention also during the early stages of MS to preserve or improve walking and balance abilities and fostering brain functional adaptation, thus slowing down the disease progression. Previous studies highlighted the need to early identify and manage gait disorders using a multimodal approach tailored on individual's need. Moreover, Functional Near-Infrared Spectroscopy (fNIRS) measures blood flow which accompanies neuronal activity and thus, it can provide spatial information about changes in cortical activation patterns due to the possible effects of exercise on cortical plasticity.
To the best of the investigators knowledge, no published studies have assessed the effect of exercise on mobility and brain activity in PwMS with minimal or clinically undetectable disability. This emphasizes the need of trials investigating the effect of walking exercise as preventive strategy on MS clinical worsening.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Investigator, Outcomes Assessor)
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
- •Age > 17 years
- •Stable disease course (without worsening over 1 point at the Expanded Disability Status Scale in the last 3 months)
排除标准
- •Major depression
- •Mini-Mental State Examination < 27
- •Other cardiovascular or orthopedic diseases that interfere with physical exercise
- •Progressive course of the disease
研究组 & 干预措施
Physical Activity
The experimental group will perform a combination of endurance and balance training tailored to the subject.
干预措施: Tailored Physical Activity (Other)
Usual Activity
The control group will perform their usual daily activities.
结局指标
主要结局
Fatigue Severity Scale (FSS)
时间窗: Baseline, Post, FollowUp_6month
Is a 9-item self-administered questionnaire to measure the perceived impact of fatigue. The minimum score is 9 and maximum score possible is 63. Higher scores represent greater fatigue severity. If the score is calculated as the mean score of the 9 items, the cut-off score for the presence of the symptom fatigue is set as scores higher than 4.
次要结局
- Endurance walking capacity(Baseline, Post, FollowUp_6month)
- Number of steps/day(Baseline, Post, FollowUp_6month)
- Differences in oxygenated hemoglobin (Delta oxyHb)(Baseline, Post, FollowUp_6month)
- Six Minute walking test (6MWT)(Baseline, Post, FollowUp_6month)
