ExerciseExSiMSNCT07304375
Effects of Exercise and Sleep on Motor Learning and Functional Abilities in Multiple Sclerosis
A study testing Aerobic Exercise and Daytime Sleep - Nap in people with Exercise and Sleep, run by Zealand University Hospital at 2 sites in Denmark.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Exercise, Sleep, Motor Learning
- What is being tested?
- Aerobic Exercise and Daytime Sleep - Nap
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 2 sitesDenmark
- Study dates
- 1 Dec 2025to 30 Nov 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Implanted devices, such as pacemakers or stimulators
- Epilepsy or neuromuscular diseases
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Martin Ballegaard, MD MPG PhD contact
Denmark2 sites, 2 recruiting
- Not yet recruiting
Section of Movement and Neuroscience, Department of Nutrition, Exercise, and Sports, University of Copenhagen
Copenhagen, 2200
Jesper Lundbye-Jensen, PhD, +45 35 32 73 30, jlundbye@nexs.ku.dk
Caroline Sadolin Muushardt, MSc, cmuu@regionsjaelland.dk
- Recruiting
Zealand University Hospital Roskilde
Roskilde, 4000
Martin Ballegaard, MD MPG PhD, +45 46323200, mbag@regionsjaelland.dk
Caroline Sadolin Muushardt, MSc, cmuu@regionsjaelland.dk
About this study
Official title: 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.
Read more
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.
Read the 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)
- Conditions
- Exercise, Sleep, Motor Learning, Memory, Multiple Sclerosis
- Being tested
- Aerobic Exercise, Daytime Sleep - Nap
- Keywords
- Aerobic Exercise, Daytime Sleep, Sleep, Learning Ability, Motor Learning, Memory, Cognitive Function, Neurorehabilitation
- Medical subject headings
- Motor Activity, Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aerobic ExerciseOther
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.
Daytime Sleep - NapBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Daytime Sleep - Nap |
What is being measured
The primary outcome is the main question the study is designed to answer.
Motor/Skill Learning
Visuomotor accuracy tracking task. Online and offline effects. Unit: Range from 0 (lowest) to 100 (highest) percent.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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)
Measured: Assessed on experiment day 1, 2, 3 and 4.
Secondary outcomes (6)
Actigraphy
Measurement of sedentary, moderate, and vigorous activity during the experiment period. Unit = hours:min.
Measured: Assessment from day 0 to experiment day 4.
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.
Measured: Assessed at the days leading up to experiment days 1,2,3, and 4.
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.
Measured: Assessed at the days leading up to experiment days 1,2,3, and 4.
Physical fitness level - work load
Graded exercise test (GXT) on an ergometer bike - maximum work load. Unit: watt
Measured: Assessed on either experiment day 1 or 3.
Physical fitness level - heart rate
Graded exercise test (GXT) on an ergometer bike - heart rate measured with a chest strap. Unit: beats per minute (BPM).
Measured: Assessed on either experiment day 1 or 3
Physical fitness level - rating of perceived exertion
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).
Measured: Assessed on either experiment day 1 or 3.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Dec 2025
- Study start1 Dec 2025
- Primary completion30 Aug 2028 (estimated)
- Study completion30 Nov 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ExerciseStudies of the same condition, open and under way.
- More trials run by Zealand University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- 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.
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zealand University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of Copenhagen
- Responsible party
- Principal investigator, Martin Ballegaard MD PhD, Zealand University Hospital
- Investigators
- Martin Ballegaard, Principal investigator, Zealand University Hospital - Roskilde
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07304375
- Sponsor's protocol ID
- SJ-1040
- Other IDs
- SJ-1040
- Acronym
- ExSiMS
- Status last verified
- Jan 2026
- First submitted
- 26 Nov 2025
- Last updated
- 8 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Aerobic Exercise and Daytime Sleep on Neurorehabilitation and Functional Abilities in Multiple Sclerosis: Evidence of Training the Brain in Neurorehabilitation
- ClinicalTrials.gov ID
- NCT07304375
- Acronym / sponsor ID
- ExSiMS / SJ-1040
- Conditions
- Exercise, Sleep, Motor Learning, Memory, Multiple Sclerosis
- Keywords
- Aerobic Exercise, Daytime Sleep, Sleep, Learning Ability, Motor Learning, Memory, Cognitive Function, Neurorehabilitation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Zealand University HospitalUniversity, hospital or other
- Collaborators
- University of Copenhagen
- Study start
- 1 Dec 2025 (actual)
- Primary completion
- 30 Aug 2028 (estimated)
- Study completion
- 30 Nov 2028 (estimated)
- First posted
- 26 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
- 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.
| Arm | Type | Receives |
|---|---|---|
| Aerobic Exercise - GXT | Experimental | Other: Aerobic ExerciseThe 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. |
| 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 | Behavioral: Daytime Sleep - NapThe 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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- Implanted devices, such as pacemakers or stimulators
- Epilepsy or neuromuscular diseases
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Aerobic ExerciseThe 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. | Other | Aerobic Exercise - GXT |
| Daytime Sleep - NapThe 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. | Behavioural | Daytime Sleep - Nap |
Primary outcome
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.
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.
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.
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).
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.
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)
6 secondary outcomes
Actigraphy
Time frame: 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.
Sleep quality - Self reported sleep duration
Time frame: 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.
Physical fitness level - heart rate
Time frame: 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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Martin Ballegaard, MD MPG PhD contact
Martin Ballegaard principal investigator
Zealand University Hospital - Roskilde
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aerobic Exercise and Daytime Sleep - Nap in people with Exercise and Sleep, run by Zealand University Hospital at 2 sites in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Caroline Sadolin Muushardt, MSc (+45 46323200, cmuu@regionsjaelland.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Motor/Skill Learning (time frame: Assessed on experiment days 1, 2, 3 and 4.). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jan 2026.