Effects of Exercise and Sleep on Motor Learning and Functional Abilities in Multiple Sclerosis
NCT ID: NCT07304375
Last Updated: 2025-12-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
20 participants
INTERVENTIONAL
2025-12-01
2028-11-30
Brief Summary
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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
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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
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Keywords
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Study Design
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RANDOMIZED
CROSSOVER
SUPPORTIVE_CARE
NONE
Study Groups
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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.
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.
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.
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.
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.
No interventions assigned to this group
Interventions
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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.
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.
Eligibility Criteria
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Inclusion Criteria
* Expanded Disability Status Score, 1 \< EDSS \< 4.5
* MRC muscle strength ≥ 4+ in the dominant hand
Exclusion Criteria
* Epilepsy or neuromuscular diseases
18 Years
70 Years
ALL
No
Sponsors
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University of Copenhagen
OTHER
Zealand University Hospital
OTHER
Responsible Party
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Martin Ballegaard MD PhD
Clinical Associate Professor
Principal Investigators
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Martin Ballegaard
Role: PRINCIPAL_INVESTIGATOR
Zealand University Hospital - Roskilde
Locations
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Section of Movement and Neuroscience, Department of Nutrition, Exercise, and Sports, University of Copenhagen
Copenhagen, , Denmark
Zealand University Hospital Roskilde
Roskilde, , Denmark
Countries
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Central Contacts
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Facility Contacts
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Jesper Lundbye-Jensen, PhD
Role: primary
Caroline Sadolin Muushardt, MSc
Role: backup
Martin Ballegaard, MD MPG PhD
Role: primary
Caroline Sadolin Muushardt, MSc
Role: backup
Other Identifiers
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SJ-1040
Identifier Type: OTHER
Identifier Source: secondary_id
SJ-1040
Identifier Type: -
Identifier Source: org_study_id