NCT07304375 Effects of Exercise and Sleep on Motor Learning and Functional Abilities in Multiple Sclerosis
| NCT ID | NCT07304375 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Zealand University Hospital |
| Condition | Exercise |
| Study Type | INTERVENTIONAL |
| Enrollment | 20 participants |
| Start Date | 2025-12-01 |
| Primary Completion | 2028-08-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 20 participants in total. It began in 2025-12-01 with a primary completion date of 2028-08-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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.
Eligibility Criteria
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
Contact & Investigator
Martin Ballegaard
PRINCIPAL INVESTIGATOR
Zealand University Hospital - Roskilde
Frequently Asked Questions
Who can join the NCT07304375 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 70 Years, studying Exercise. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07304375 currently recruiting?
Yes, NCT07304375 is actively recruiting participants. Contact the research team at cmuu@regionsjaelland.dk for enrollment information.
Where is the NCT07304375 trial being conducted?
This trial is being conducted at Copenhagen, Denmark, Roskilde, Denmark.
Who is sponsoring the NCT07304375 clinical trial?
NCT07304375 is sponsored by Zealand University Hospital. The principal investigator is Martin Ballegaard at Zealand University Hospital - Roskilde. The trial plans to enroll 20 participants.