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

NCT07304375 | Recruiting

• 1 other identifier: SJ-1040
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 2

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.

Conditions

Exercise; Sleep; Motor Learning; Memory; Multiple Sclerosis

Keywords

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

Outcome Measures

Primary Outcomes (6)

• Motor/Skill Learning

  Visuomotor accuracy tracking task. Online and offline effects. Unit: Range from 0 (lowest) to 100 (highest) percent.

  Assessed on experiment days 1, 2, 3 and 4.

• Neurophysiological Measurement I - Cortical Activity

  Cortical activity will be measured with electroencephalography (EEG) during skill acquisition. Unit: EEG Power in several frequency bands.

  Assessed on experiment day 1, 2, 3 and 4.

• Neurophysiological Measurement II - Muscular Activity

  Muscle activity will be measured with electromyography (EMG) during skill acquisition. Unit: EMG amplitude.

  Assessed on experiment day 1, 2, 3 and 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).

  Assessed on experiment day 1, 2, 3 and 4.

• Neurophysiological Measurement IV - Corticomuscular Functional Connectivity

  Corticomuscular functional connectivity during skill acquisition will be measured with functional coupling between EEG and EMG. Unit: functional coupling in EEG-EMG.

  Assessed on experiment day 1, 2, 3 and 4.

• Neurophysiological Measurement V - Muscular Functional Connectivity

  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)

  Assessed on experiment day 1, 2, 3 and 4.

Secondary Outcomes (6)

• 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

Other Outcomes (4)

• Wakefulness

  Assessed on experiment days 1, 2, 3 and 4.

• Handedness

  Assessed on day 0.

• Reaction Time Task

  Assessed on day 0.

Study Arms (3)

Aerobic Exercise - GXT

EXPERIMENTAL

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.

Other: Aerobic Exercise

Control - Rest

NO INTERVENTION

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

EXPERIMENTAL

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.

Behavioral: Daytime Sleep - Nap

Interventions

Aerobic Exercise OTHER

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.

Aerobic Exercise - GXT

Daytime Sleep - Nap BEHAVIORAL

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.

Daytime Sleep - Nap

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Zealand University Hospital: lead
• University of Copenhagen: collaborator

Study Sites (2)

Section of Movement and Neuroscience, Department of Nutrition, Exercise, and Sports, University of Copenhagen

Copenhagen, 2200, Denmark

NOT YET RECRUITING

Zealand University Hospital Roskilde

Roskilde, 4000, Denmark

RECRUITING

MeSH Terms

Conditions

Motor Activity; Multiple Sclerosis

Interventions

Exercise

Condition Hierarchy (Ancestors)

Behavior; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Martin Ballegaard

  Zealand University Hospital - Roskilde

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Caroline Sadolin Muushardt, MSc

CONTACT

+45 46323200; cmuu@regionsjaelland.dk

Martin Ballegaard, MD MPG PhD

CONTACT

mbag@regionsjaelland.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Associate Professor

Model Details: 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.

Study Record Dates

• First Submitted: November 26, 2025
• First Posted: December 26, 2025
• Study Start: December 1, 2025
• Primary Completion (Estimated): August 30, 2028
• Study Completion (Estimated): November 30, 2028
• Last Updated: January 8, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

DK (2)