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Effects of Exercise and Sleep on Motor Learning and Functional Abilities in Multiple Sclerosis

Effects of Aerobic Exercise and Daytime Sleep on Neurorehabilitation and Functional Abilities in Multiple Sclerosis: Evidence of Training the Brain in Neurorehabilitation

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07304375
Acronym
ExSiMS
Enrollment
20
Registered
2025-12-26
Start date
2025-12-01
Completion date
2028-11-30
Last updated
2026-01-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Exercise, Memory, Motor Learning, Multiple Sclerosis, Sleep

Keywords

Aerobic Exercise, Daytime Sleep, Sleep, Learning Ability, Motor Learning, Memory, Cognitive Function, Neurorehabilitation

Brief summary

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.

Detailed description

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: * Electroencephalography (EEG) and Electromyography (EMG) * Actigraphy/Accelerometry * Visuomotor Accuracy Tracking Task (VATT) * Training on an Ergometerbike: Graded Exercise Test (GXT), High Intensity Interval Training (HIIT) * Polysomnography (PSG)

Interventions

OTHERAerobic Exercise

The 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.

BEHAVIORALDaytime Sleep - Nap

The 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.

Sponsors

University of Copenhagen
CollaboratorOTHER
Zealand University Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Intervention model description

Due to large between-patient variability of motor function, the participants will have more than one intervention with a wash-out period in between and with a change in task complexity.

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No

Inclusion criteria

* 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

Exclusion criteria

* Implanted devices, such as pacemakers or stimulators * Epilepsy or neuromuscular diseases

Design outcomes

Primary

MeasureTime frameDescription
Motor/Skill LearningAssessed 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 I - Cortical ActivityAssessed 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 ActivityAssessed on experiment day 1, 2, 3 and 4.Muscle activity will be measured with electromyography (EMG) during skill acquisition. Unit: EMG amplitude.
Neurophysiological Measurement III - Corticocortical Functional ConnectivityAssessed 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 IV - Corticomuscular Functional ConnectivityAssessed 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 ConnectivityAssessed 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)

Secondary

MeasureTime frameDescription
Physical fitness level - work loadAssessed on either experiment day 1 or 3.Graded exercise test (GXT) on an ergometer bike - maximum work load. Unit: watt
Sleep quality - Self reported sleep durationAssessed at the days leading up to experiment days 1,2,3, and 4.Self-reported sleep duration will be measured by the National Sleep Foundation Sleep Diary translated to Danish. Unit: Hour:min.
ActigraphyAssessment from day 0 to experiment day 4.Measurement of sedentary, moderate, and vigorous activity during the experiment period. Unit = hours:min.
Sleep quality - self reported sleep latency.Assessed at the days leading up to experiment days 1,2,3, and 4.Self-reported sleep latency will be measured by the National Sleep Foundation Sleep Diary translated to Danish. Unit: Hour:minutes.
Physical fitness level - heart rateAssessed on either experiment day 1 or 3Graded exercise test (GXT) on an ergometer bike - heart rate measured with a chest strap. Unit: beats per minute (BPM).
Physical fitness level - rating of perceived exertionAssessed on either experiment day 1 or 3.Graded exercise test (GXT) on an ergometer bike - rating of perceived exertion with the Borg scale. Unit: Borg scale 6-20 (6 = rest, 20 = maximal exhaustion).

Other

MeasureTime frameDescription
WakefulnessAssessed on experiment days 1, 2, 3 and 4.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.
HandednessAssessed on day 0.Handedness questionnaire to determine the participant's dominant hand. Unit: Laterality index (-100.00 (lefthanded) to 100.00 (righthanded).
Reaction Time TaskAssessed on day 0.A simple Reaction Time Task on a computer. Unit: ms.
The fatigue scale for motor and cognitive functions (FSMC)Assessed on day 0.Questionnaire measuring fatigue in individuals with Multiple Sclerosis. Unit: FSMC\_total = Points from 20-100 (≥ 43 Mild Fatigue, ≥ 53 Moderate Fatigue, ≥ 63 Severe Fatigue).

Countries

Denmark

Contacts

Primary ContactCaroline Sadolin Muushardt, MSc
cmuu@regionsjaelland.dk+45 46323200
Backup ContactMartin Ballegaard, MD MPG PhD
mbag@regionsjaelland.dk

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026