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

January 5, 2026 updated by: Martin Ballegaard MD PhD, Zealand University Hospital

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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)

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
20

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Denmark
      • Copenhagen, Denmark, 2200
        • Not yet recruiting
        • Section of Movement and Neuroscience, Department of Nutrition, Exercise, and Sports, University of Copenhagen
        • Contact:
        • Contact:
      • Roskilde, Denmark, 4000

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: 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.
Other: Aerobic 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.
No Intervention: 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.
Experimental: 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.
Behavioral: Daytime 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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Motor/Skill Learning
Time Frame: 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.
Assessed on experiment days 1, 2, 3 and 4.
Neurophysiological Measurement I - Cortical Activity
Time Frame: 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.
Assessed on experiment day 1, 2, 3 and 4.
Neurophysiological Measurement II - Muscular Activity
Time Frame: Assessed on experiment day 1, 2, 3 and 4.
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
Time Frame: 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).
Assessed on experiment day 1, 2, 3 and 4.
Neurophysiological Measurement IV - Corticomuscular Functional Connectivity
Time Frame: 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.
Assessed on experiment day 1, 2, 3 and 4.
Neurophysiological Measurement V - Muscular Functional Connectivity
Time Frame: 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)
Assessed on experiment day 1, 2, 3 and 4.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Actigraphy
Time Frame: Assessment from day 0 to experiment day 4.
Measurement of sedentary, moderate, and vigorous activity during the experiment period. Unit = hours:min.
Assessment from day 0 to experiment day 4.
Sleep quality - self reported sleep latency.
Time Frame: 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.
Assessed at the days leading up to experiment days 1,2,3, and 4.
Sleep quality - Self reported sleep duration
Time Frame: Assessed 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.
Assessed at the days leading up to experiment days 1,2,3, and 4.
Physical fitness level - work load
Time Frame: Assessed on either experiment day 1 or 3.
Graded exercise test (GXT) on an ergometer bike - maximum work load. Unit: watt
Assessed on either experiment day 1 or 3.
Physical fitness level - heart rate
Time Frame: Assessed on either experiment day 1 or 3
Graded exercise test (GXT) on an ergometer bike - heart rate measured with a chest strap. Unit: beats per minute (BPM).
Assessed on either experiment day 1 or 3
Physical fitness level - rating of perceived exertion
Time Frame: Assessed 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).
Assessed on either experiment day 1 or 3.

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Wakefulness
Time Frame: Assessed 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".
Assessed on experiment days 1, 2, 3 and 4.
Handedness
Time Frame: Assessed on day 0.
Handedness questionnaire to determine the participant's dominant hand. Unit: Laterality index (-100.00 (lefthanded) to 100.00 (righthanded).
Assessed on day 0.
Reaction Time Task
Time Frame: Assessed on day 0.
A simple Reaction Time Task on a computer. Unit: ms.
Assessed on day 0.
The fatigue scale for motor and cognitive functions (FSMC)
Time Frame: 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).
Assessed on day 0.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Zealand University Hospital

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
University of Copenhagen

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Martin Ballegaard, Zealand University Hospital - Roskilde

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 30, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 30, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 26, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 11, 2025

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 26, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 8, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 5, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • SJ-1040 (Other Identifier: De Videnskabelige Komitéer)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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