Effects of Exercise and Sleep on Motor Learning and Functional Abilities in Multiple Sclerosis
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-70
SponsorZealand University Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Implanted devices, such as pacemakers or stimulators
Epilepsy or neuromuscular diseases
Trial design
Design model
Crossover
Treatments tested in this trial
Aerobic Exercise
Other interventionThe Aerobic Exercise Intervention consists of 20 minutes of Graded Exercise Test (GXT) on an ergometer bike. The participants start with 5 minutes of warm-up. The wattload will then be increased until exhaustion.
Daytime Sleep - Nap
BehavioralThe Daytime sleep consists of a 30-minute nap after the acquisition of the visuomotor accuracy tracking task. The participants will be asked to rest in a supine position in a bed in a dark and quiet room.
Treatment groups
20 Participants
are divided into 3 treatment groupsGroup A: Aerobic Exercise - GXTExperimental treatment 1 intervention
Group B: Control - RestNo intervention 0 interventions
Group C: Daytime Sleep - NapExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Motor/Skill Learning
Visuomotor accuracy tracking task. Online and offline effects. Unit: Range from 0 (lowest) to 100 (highest) percent.
Time frame
Assessed on experiment days 1, 2, 3 and 4.2
Neurophysiological Measurement I - Cortical Activity
Cortical activity will be measured with electroencephalography (EEG) during skill acquisition. Unit: EEG Power in several frequency bands.
Time frame
Assessed on experiment day 1, 2, 3 and 4.3
Neurophysiological Measurement II - Muscular Activity
Muscle activity will be measured with electromyography (EMG) during skill acquisition. Unit: EMG amplitude.
Time frame
Assessed on experiment day 1, 2, 3 and 4.4
Neurophysiological Measurement III - Corticocortical Functional Connectivity
Corticocortical functional connectivity will me measured as functional coupling in EEG during skill acquisition. Unit: functional coupling in EEG (scale 0-1).
Time frame
Assessed on experiment day 1, 2, 3 and 4.Secondary outcomes
1
Actigraphy
Measurement of sedentary, moderate, and vigorous activity during the experiment period. Unit = hours:min.
Time frame
Assessment from day 0 to experiment day 4.2
Sleep quality - self reported sleep latency.
Self-reported sleep latency will be measured by the National Sleep Foundation Sleep Diary translated to Danish. Unit: Hour:minutes.
Time frame
Assessed at the days leading up to experiment days 1,2,3, and 4.3
Sleep quality - Self reported sleep duration
Self-reported sleep duration will be measured by the National Sleep Foundation Sleep Diary translated to Danish. Unit: Hour:min.
Time frame
Assessed at the days leading up to experiment days 1,2,3, and 4.4
Physical fitness level - work load
Graded exercise test (GXT) on an ergometer bike - maximum work load. Unit: watt
Time frame
Assessed on either experiment day 1 or 3.Other outcomes
1
Wakefulness
Wakefulness will be measured by the Stanford Sleepiness Scale: From 1 to 7. 1= "Feeling active and vital; alert; wide awake". 7= "Almost in reverie; sleep onset soon; lost struggle to remain awake. X = Asleep".
Time frame
Assessed on experiment days 1, 2, 3 and 4.2
Handedness
Handedness questionnaire to determine the participant's dominant hand. Unit: Laterality index (-100.00 (lefthanded) to 100.00 (righthanded).
Time frame
Assessed on day 0.3
Reaction Time Task
A simple Reaction Time Task on a computer. Unit: ms.
Time frame
Assessed on day 0.4
The fatigue scale for motor and cognitive functions (FSMC)
Questionnaire measuring fatigue in individuals with Multiple Sclerosis. Unit: FSMC\_total = Points from 20-100 (≥ 43 Mild Fatigue, ≥ 53 Moderate Fatigue, ≥ 63 Severe Fatigue).
Time frame
Assessed on day 0.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Zealand University Hospital
Lead sponsor
University of Copenhagen
Collaborator
Source ClinicalTrials.gov