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| ID | Type | Description | Link |
|---|---|---|---|
| SJ-1040 | Other Identifier | De Videnskabelige Komitéer |
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| Name | Class |
|---|---|
| University of Copenhagen | OTHER |
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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Actigraphy | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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". | Assessed on experiment days 1, 2, 3 and 4. |
| Handedness |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Caroline Sadolin Muushardt, MSc | Contact | +45 46323200 | cmuu@regionsjaelland.dk | |
| Martin Ballegaard, MD MPG PhD | Contact | mbag@regionsjaelland.dk |
| Name | Affiliation | Role |
|---|---|---|
| Martin Ballegaard | Zealand University Hospital - Roskilde | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Section of Movement and Neuroscience, Department of Nutrition, Exercise, and Sports, University of Copenhagen | Not yet recruiting | Copenhagen | 2200 | Denmark |
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| ID | Term |
|---|---|
| D009043 | Motor Activity |
| D009103 | Multiple Sclerosis |
| ID | Term |
|---|---|
| D001519 | Behavior |
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D015444 | Exercise |
| ID | Term |
|---|---|
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
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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.
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| 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. |
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| Assessed on experiment day 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 | 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 | 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 | 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 | 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. |
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 | A simple Reaction Time Task on a computer. Unit: ms. | 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). | Assessed on day 0. |
| Zealand University Hospital Roskilde | Recruiting | Roskilde | 4000 | Denmark |
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| D003711 | Demyelinating Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |