An interventional study of Aerobic Exercise and Daytime Sleep - Nap in Exercise, Sleep and Motor Learning, sponsored by Zealand University Hospital. Recruiting at 2 sites in Denmark. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-01-08.
Sponsored by Zealand University Hospital · Not applicable, Interventional, and Supportive care
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:
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.
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:
2,426 studies on the registry are indexed under Motor Activity; 1,161 are open to participants now.
This study's planned enrollment of 20 is below the median of 60 across 2,118 interventional studies indexed under Motor Activity.
Browse Motor Activity studies →Zealand University Hospital is the lead sponsor of 234 studies on the registry; 51 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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 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.
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 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.
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.
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.
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.
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.
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.
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.
Time frame: 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)
Time frame: Assessed on experiment day 1, 2, 3 and 4.
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.
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.
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.
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.
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).
Time frame: 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).
Time frame: Assessed on either experiment day 1 or 3.
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.
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.
Reaction Time Task
A simple Reaction Time Task on a computer. Unit: ms.
Time frame: Assessed on day 0.
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.
Plan to share: No
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