Improving brain health in multiple sclerosis through aerobic exercise
Improving brain health in people with multiple sclerosis: cerebrovascular and cerebral oxygen metabolic adaptation to aerobic training. A randomised controlled trial
What it found
No result yet.
What it measured
Main measures
Difference in cerebral blood flow (mL/100 g/min) response to hypoxia phase contrast mapping MRI
baseline and 12 weeks
MRI lesions
Other measures (9)
Difference in cerebral metabolic rate of oxygen response to hypoxia phase contrast mapping MRI and susceptibility-based oximetry MRI
baseline and week 12
MRI lesionsDifference in cerebral lactate response to hypoxia magnetic resonance spectroscopy
baseline and week 12
MRI lesionsDifference in blood-brain barrier permeability in normal-appearing white matter, grey matter and white matter lesions dynamic contrast-enhanced MRI
baseline and week 12
MRI lesionsAerobic capacity maximal oxygen uptake
baseline and week 12
Physical functionWalking distance the 6-minute walk test (6MWT)
baseline and week 12
Walking and mobilityWalking speed the timed 25-foot walk (T25FW)
baseline and week 12
Disability progressionWalking and mobilityFatigue Fatigue Scale for Motor and Cognitive Functions (FSMC)
baseline and week 12
Thinking and memoryFatigueDisease impact the Multiple Sclerosis Impact Scale-29 (MSIS-29)
baseline and week 12
Quality of life (reported by participants)Changes in blood biomarkers (including neuroaxonal injury, astrocytic activation, inflammation and neurotrophic signalling) in response to aerobic exercise blood concentrations of NfL, GFAP, IL-6, BDNF and IGF-1
baseline and week 12
Blood or spinal fluid markersPhysical functionImmune response
Who could take part
MS (type not specified) · 18 to 100 · EDSS 2.0 to 6.0
Show the full criteria
Inclusion criteria
Inclusion: 1. Multiple sclerosis according to the 2024 McDonald criteria, any disease course 2. Expanded Disability Status Scale (EDSS) score 2.0–6.0 3. Able to attend training twice weekly for 12 weeks 4. Healthy controls: age- and sex-matched to the participants with MS 5. All participants: aged 18 years or older and able to communicate in Danish Exclusion: 1. Aerobic exercise more than 5 hours per week 2. Body mass index >30 kg/m² 3. Smoking 4. Severe claustrophobia 5. Diabetes or cardiovascular disease that prevents physical training 6. Known severe lung disease that prevents exercise training or the hypoxia protocol 7. Other neurological disease, including previous stroke or transient ischaemic attack (healthy controls: any neurological disease) 8. Haemodynamically significant carotid stenosis 9. Severe kidney disease or eGFR <40 mL/min/1.73 m² 10. Pregnancy or breastfeeding 11. Surgery within the past 6 weeks 12. Metal implants or foreign bodies that contraindicate MRI
Exclusion criteria
Not separately supplied in the registry.
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
Background and study aims Multiple sclerosis (MS) is a condition in which the body's immune system attacks the brain and spinal cord. Even with treatment, many people with MS experience fatigue, problems with thinking and memory, and reduced physical function. Researchers have found that the blood vessels in the brain may not work as well in people with MS. This could make the brain less able to cope with physical stress and may contribute to brain damage over time. The aim of this study is to find out whether a 12-week aerobic exercise programme can improve blood flow in the brain and support brain health in people with MS. The researchers will also investigate whether exercise affects the brain's oxygen use, the blood-brain barrier, fitness, walking ability, fatigue, and the impact of MS on daily life. Who can participate? Adults aged 18 years or older with multiple sclerosis can take part if they: 1. Meet the current diagnostic criteria for MS 2. Have a disability score between 2.0 and 6.0 on the Expanded Disability Status Scale 3. Are able to attend exercise training sessions twice a week for 12 weeks 4. Can communicate in Danish The study will also include healthy volunteers of a similar age and sex for comparison. What does the study involve? Participants with MS will be randomly assigned to either: 1. A supervised aerobic exercise programme plus their usual care 2. Usual care alone The exercise programme involves cycling on an exercise bike twice a week for 12 weeks. Each session lasts between 30 minutes and 60 minutes. Participants will undergo a range of assessments before the study begins and again after 12 weeks. These include MRI scans of the brain, fitness tests, walking tests, blood sample collection, and questionnaires about fatigue and the effects of MS on daily life. During some MRI scans, participants will wear a face mask and breathe air with lower oxygen levels for a short period so that researchers can assess how the brain responds. Some participants with MS may also be invited for further assessments at 12 months and 24 months after the study intervention. What are the possible benefits and risks of participating? Participants in the exercise group may improve their fitness and physical function. The study may also help researchers better understand how exercise affects brain health in people with MS, which could benefit future patients. Possible risks include discomfort during exercise testing or training, temporary discomfort during MRI scans, and discomfort associated with blood sample collection. Some people may find MRI scanning uncomfortable, particularly if they dislike enclosed spaces. Participants will be monitored throughout the study, and exercise sessions will be stopped if MS symptoms worsen. Where is the study run from? The study is being run from the Department of Clinical Physiology and Nuclear Medicine at Rigshospitalet in Glostrup, Denmark. Participants are being recruited in Denmark. When is the study starting and how long is it expected to run for? November 2026 to December 2032. Who is funding the study? The study is funded by Scleroseforeningen (the Danish Multiple Sclerosis Society), a Danish non-profit organisation. Who is the main contact? Oliver Thistrup Kiehn, oliver.thistrup.kiehn.01@regionh.dk Principal Investigator: Professor Henrik Bo Wiberg Larsson, henrik.bo.wiberg.larsson@regionh.dk
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History
Started
Nov 2026
Finished
Dec 2032