Effects of Aerobic Exercise and Daytime Sleep on Neurorehabilitation and Functional Abilities in Multiple Sclerosis: Evidence of Training the Brain in Neurorehabilitation
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Motor/Skill Learning
研究概览
简要总结
The ExSiMS study is a randomized, controlled crossover study including 20 individuals (18-70 years) diagnosed with relapsing remitting Multiple Sclerosis (MS) This project investigates, through behavioral and neurophysiological measurements, how aerobic exercise on an ergometer bike and sleep in the form of a nap and overnight sleep may enhance cortical motor skill learning evaluated by a complex hand motor skill test and thereby improve functional capacity in individuals with MS. Beyond the effect on motor skill learning, the project investigate the effect on electroencephalography (EEG) - electromyography (EMG) coherence.
The study hypothesizes that individuals with neurological conditions, such as multiple sclerosis (MS), may experience beneficial effects on specific motor rehabilitation through systematically planned cardiovascular exercise and sleep scheduling, due to positive impacts on memory consolidation.
Aims:
- Investigate the brain's neurophysiological responses and memory effects following a training intervention and, separately, sleep, in the form of a power nap, in individuals with MS.
- Examine whether these effects persist beyond the few days previously observed in healthy individuals by implementing a longer-term intervention.
- Explore whether the training effect is influenced by disease activity in the brain, such as during relapses and during immunosuppressive treatment.
- Assess whether the presence of abnormally reduced cognitive endurance (fatigue) affects the impact of the intervention involving exercise and sleep.
The study is based on documented positive effects of physical activity and sleep in both young and older adults, as well as in individuals recovering from stroke. The research thus offers promising perspectives for broader applications within neurorehabilitation, and particularly for MS, as the disease is associated with functional impairments. At the same time, both physical exercise and sleep represent meaningful interventions that should be thoughtfully integrated into rehabilitation strategies.
详细描述
The ExSiMS-project consists of both a proof-of-concept study and a longitudinal study.
In both studies, participants will perform a visuomotor accuracy tracking task (VATT) with their dominant hand on the main experimental days. The participants will wear EEG and EMG electrodes during the VATT. This will make it possible to investigate cortical activity during skill acquisition and later analyse the corticomuscular coherence. After the VATT, the participants will be randomized to either 20 min aerobic exercise on an ergometer bike, a short 30-minute nap or control (sitting rest). The interventions will run over a longer period of time in the longitudinal study.
The participants will be asked to do a retention test of the visuomotor accuracy tracking task 24 hours later.
The studies will run over more experiment days divided into two experiment blocks of at least two experiment days separated by between two weeks to three months.
Methods:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Supportive Care
- 盲法
- None
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
- •Competent individuals (aged 18-70) diagnosed with early relapsing-remitting MS
- •Expanded Disability Status Score, 1 < EDSS < 4.5
- •MRC muscle strength ≥ 4+ in the dominant hand
排除标准
- •Implanted devices, such as pacemakers or stimulators
- •Epilepsy or neuromuscular diseases
研究组 & 干预措施
Aerobic Exercise - GXT
The aerobic exercise will consist of about 20 minutes of Graded Exercise Training (GXT) on an ergometer bike. The experimenter will instruct and motivate the participant through the aerobic exercise.
干预措施: Aerobic Exercise (Other)
Control - Rest
The participant will rest in a sitting position in a quiet room for 20 minutes. The participant is allowed to read or engage in similar quiet and sitting activities.
Daytime Sleep - Nap
The participants will be asked to try and take a 30-minute nap. The participant will be provided with a bed in a dark and quiet room.
干预措施: Daytime Sleep - Nap (Behavioral)
结局指标
主要结局
Motor/Skill Learning
时间窗: Assessed on experiment days 1, 2, 3 and 4.
Visuomotor accuracy tracking task. Online and offline effects. Unit: Range from 0 (lowest) to 100 (highest) percent.
Neurophysiological Measurement III - Corticocortical Functional Connectivity
时间窗: Assessed on experiment day 1, 2, 3 and 4.
Corticocortical functional connectivity will me measured as functional coupling in EEG during skill acquisition. Unit: functional coupling in EEG (scale 0-1).
Neurophysiological Measurement I - Cortical Activity
时间窗: Assessed on experiment day 1, 2, 3 and 4.
Cortical activity will be measured with electroencephalography (EEG) during skill acquisition. Unit: EEG Power in several frequency bands.
Neurophysiological Measurement II - Muscular Activity
时间窗: Assessed on experiment day 1, 2, 3 and 4.
Muscle activity will be measured with electromyography (EMG) during skill acquisition. Unit: EMG amplitude.
Neurophysiological Measurement IV - Corticomuscular Functional Connectivity
时间窗: Assessed on experiment day 1, 2, 3 and 4.
Corticomuscular functional connectivity during skill acquisition will be measured with functional coupling between EEG and EMG. Unit: functional coupling in EEG-EMG.
Neurophysiological Measurement V - Muscular Functional Connectivity
时间窗: Assessed on experiment day 1, 2, 3 and 4.
Muscular functional connectivity during skill acquisition will be assessed using EMG-EMG coherence between M. Abductor Pollicis Brevis and First Dorsal Interosseus. Unit: EMG-EMG coherence (0-1)
次要结局
- Actigraphy(Assessment from day 0 to experiment day 4.)
- Sleep quality - self reported sleep latency.(Assessed at the days leading up to experiment days 1,2,3, and 4.)
- Sleep quality - Self reported sleep duration(Assessed at the days leading up to experiment days 1,2,3, and 4.)
- Physical fitness level - work load(Assessed on either experiment day 1 or 3.)
- Physical fitness level - heart rate(Assessed on either experiment day 1 or 3)
- Physical fitness level - rating of perceived exertion(Assessed on either experiment day 1 or 3.)
研究者
Martin Ballegaard MD PhD
Clinical Associate Professor
Zealand University Hospital