An interventional study of Systematic exercise training and Educational program in Multiple Sclerosis, sponsored by University of Aarhus. Completed at 1 site in Denmark. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2022-11-03.
Sponsored by University of Aarhus · Not applicable, Interventional, and Treatment
Among 16 studies in Multiple Sclerosis by University of Aarhus — 2 open to participants now, 2 under way, none of them phase 3. Multiple Sclerosis · University of Aarhus.
Among the 16 studies in Multiple Sclerosis by University of Aarhus, this one is the 6th largest by enrollment of the 13 interventional ones that give a count, is one of 2 that started in 2018, is one of 11 with no phase, and was the 7th registered.
3,264 studies on the registry are indexed under Multiple Sclerosis; 659 are open to participants now.
Browse Multiple Sclerosis studies →2 of the 16 studies in Multiple Sclerosis by University of Aarhus are open now, in 1 country. Recruiting first, the newest first:
University of Aarhus · Sites in Denmark
University of Aarhus · Sites in Denmark
By country, each count listing its studies:
Of the 430 Multiple Sclerosis studies recruiting now, 163 (38%) set no upper age limit and 211 (49%) stop at 75 or younger; 40 take children under 18; 96 take healthy volunteers.
This study: 18 Years to 60 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
16 studies; the count open now beside each. This study's row is marked.
First in 2000; this study’s year is marked. 2 started in 2018.
This study's enrollment of 84 is above the median of 50 across 2,201 interventional studies indexed under Multiple Sclerosis.
Median enrollment 71 across the 13 interventional studies, 83 across the 3 observational. Of the 13 that completed or were terminated, 0 (0%) have results posted.
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University of Aarhus is the lead sponsor of 1,300 studies on the registry; 189 are open to participants now.
None of the studies under way reaches primary completion within a year.
Among the 16 studies in Multiple Sclerosis by University of Aarhus, from their registry updates:
Nothing recorded among them since 2026-09-25.
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This study seeks to investigate whether early exercise efforts can expand the use of exercise in Multiple sclerosis (MS), from symptom treatment only, to early supplementary disease-modifying treatment.
The study will be conducted in a randomized and controlled manner, with single blinding. Participants will be allocated to either a systematic aerobic exercise intervention or an educational programme on exercise and physical activity. Both interventions will last 1 year, and involve a 1 year follow-up period.
It is hypothesized that early exercise efforts can modify the disease activity and disability progression.
Multiple Sclerosis (MS) is an autoimmune and neurodegenerative disease in the central nervous system (CNS), characterized by a complex pathogenesis and heterogeneous symptoms. The histopathological hallmark of the disease is sclerotic lesions. These inflammatory lesions manifests as disabling relapses, and the number of relapses in the first few years after disease onset is associated with progression of disability, with a higher number of relapses leading to a more rapid progression. In addition, diffuse neurodegeneration seems to occur early in the disease, and even though it is not always clinically evident it is associated with disease progression. A reduction in relapse rate and neurodegeneration early in the MS disease course may slow the progression of disabilities and can possibly reduce overall disease burden. For the individual person with MS (pwMS) a reduction in overall disease burden will often improve quality of life, and since MS is a lifelong disease this is of great interest. Preventing disability in pwMS is also highly relevant in a societal perspective, as it lowers the large costs associated with increased disability. As a consequence, the importance of early treatment have been emphasized.
Treatment of MS have seen great advances in the recent years, resulting in an increasing number of available disease-modifying treatments (DMT). Despite the fact that the current DMTs favourable alter a number of clinical outcomes and the course of the disease, it is still a serious and deteriorating condition with significant disease activity, impaired neurological functions and thus progression of disabilities. New and supplemental treatment strategies are therefore still warranted, and exercise have gained attention as a safe and tolerable rehabilitation strategy. Recently, exercise furthermore have gained substantial attention, as the first indications of neuroprotective and disease-modifying effects of exercise has been published. However, despite the focus on early treatment in medical DMTs no studies have investigated the effects of exercise as a supplemental treatment strategy early in the disease course of MS.
Consequently, the purpose of this study is to investigate the effects of early exercise efforts on disease activity and disability progression. In a sub-group the effects will furthermore be investigated on brain volume, specific brain regions, and inflammation.
It is hypothesized that early exercise efforts can modify the disease activity and disability progression, by reducing the relapse rate, the progression of Multiple Sclerosis Functional Composite (MSFC) and Expanded Disability Status Scale (EDSS) scores. The rate of brain atrophy and the lesion load, obtained by MRI scans, is also hypothesized to be reduced. This is expected to be due to an exercise-induced reduction in inflammation.
The study will be a randomised and controlled study with randomisation to either an systematic aerobic exercise intervention or an educational programme on exercise and physical activity. Both interventions are in addition to standard treatment, and will last 1 year. The exercise intervention will consist of 2 supervised exercise sessions per week in the complete duration of the study, while the standard treatment plus exercise education program will consist of 4 educational sessions on the health benefits associated with exercise and physical activity held every third month throughout the intervention period. The training in the exercise group will be aerobic exercise (running, cycling, rowing or on a cross-trainer) planned by exercise physiologists and performed in a progressive manner. To allow handling of a large number of participants, who is also geographically spread, the exercise intervention will be locally anchored, but at the same time supervised by student employees from Section for Sports Science and controlled by internet- and telephonic communication. In addition to the two intervention groups, data from The Danish MS registry will serve as population based standard treatment control data. All groups will be followed up 1 year after cessation of the interventions.
To set the estimated number of participants a two-sample two-sided power calculation has been conducted. The basis for this calculation is an report from Tallner et al. who have shown a difference in relapse rate during a two-year period (equal to our 1 year intervention, and 1 year follow-up) of 0.65 relapses between physically active and physically inactive MS patients (active: 0.95 +/- 0.97 relapses in 2 years ; inactive: 1.60 +/- 1.64 relapses in 2 years). 83 patients with MS should be enrolled in each intervention group (a 20% drop-out rate has been included). Newly published data on the brain atrophy in percentage of total brain volume after 24 weeks of resistance training have been the basis for a similar calculation of the number of participants in the sub-group, from whom MRI-scans and blood samples will be obtained. 41 participants from each intervention group should form this sub-group.
MS is a complex disease with heterogenous symptoms, and by combining the disciplines of exercise physiology, neurology and radiology this study can be the first long-term and large-scale exercise study to investigate the possible neuroprotective and disease-modifying effects of exercise when initiated early in the disease course of MS. Consequently, this project has the potential to change present clinical practice and generate further attention to exercise, not only as symptom treatment, but also as an supplemental disease-modifying treatment strategy early in the course of MS.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Two weekly supervised aerobic exercise trainings for 48 weeks. The training will be planned by exercise physiologists, and performed in a progressive manner.
Combination Product: Systematic exercise training
Educational program on physical activity and health, consisting of four educational sessions in the intervention period.
Behavioral: Educational program
Data from The Danish MS Registry will serve as control-data for standard treatment alone.
Combination of standard medical treatment and systematic early exercise training in persons with MS.
Informations regarding health benefits of physical activity and exercise.
Change in Annual Relapse Rate (ARR)
Number of relapses, registered and validated by neurologist, on annual basis
Time frame: ARR, 1 year intervention; 1 year follow up.
Percentage brain volume change
Brain atrophy will be measured from MRI-scans
Time frame: Baseline, 24 weeks, after 1 year intervention, and again at 1 year follow up.
Multiple Sclerosis Functional Composite (MSFC)
Composite score from Timed 25-Feet Walk Test (T25FWT), 9-Hole Peg Test (9HPT), Paced Auditory Serial Addition Test (PASAT)
Time frame: Baseline, 24 weeks, after 1 year intervention, and again at 1 year follow up.
Expanded Disability Status Scale (EDSS) score
Disability status score assessed and registered by neurologist. The scale ranges from 0-10 in 0.5 unit increments representing higher levels of disability.
Time frame: Baseline, after 1 year intervention, and again at 1 year follow up.
Functional capacity, Six-minute walk test (6MWT)
Distance covered during a six-minute maximal walking test
Time frame: Baseline, 24 weeks, after 1 year intervention, and again at 1 year follow up.
Functional capacity, Six-spot-step-test (SSST)
SSSt is a measure of walking ability, balance and coordination. Measured as the time to complete the six-spot course.
Time frame: Baseline, 24 weeks, after 1 year intervention, and again at 1 year follow up.
Functional capacity, Accelerometry
Measurement of level of physical activity by wearing a accelerometer for 7 days at each timepoint. Measured in counts/min.
Time frame: Baseline, 24 weeks, after 1 year intervention, and again at 1 year follow up.
Aerobic capacity
Maximal oxygen uptake test on bike ergometer, measured by indirect calorimetry.
Time frame: Baseline, 24 weeks, after 1 year intervention, and again at 1 year follow up.
Cognition, Symbol Digit Modality Test (SDMT)
Assessment of cognitive function (processing speed), with a higher number of correct answers in the test representing better cognitive function.
Time frame: Baseline, 24 weeks, after 1 year intervention, and again at 1 year follow up.
Cognition, Paced Auditory Serial Addition Test (PASAT)
Assessment of cognitive function (processing speed and memory), with a higher number of correct answers in the test representing better cognitive function.
Time frame: Baseline, 24 weeks, after 1 year intervention, and again at 1 year follow up.
Cognition, Selective Reminding Test (SRT)
Assessment of cognitive function (memory), with a higher number of correct answers in the test representing better cognitive function.
Time frame: Baseline, 24 weeks, after 1 year intervention, and again at 1 year follow up.
Short Form Health Survey 36 (SF-36)
Questionnaire assessing health status. The SF-36 consists of eight subscales, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability.
Time frame: Baseline, 24 weeks, after 1 year intervention, and again at 1 year follow up.
Multiple Sclerosis Impact Scale 29 (MSIS-29)
Questionnaire assessing the impact of the disease. 20 questions measure the physical impact, and 9 questions measure the psychological impact. Each question is scored from 1-5. A greater score is equal to a larger impact.
Time frame: Baseline, 24 weeks, after 1 year intervention, and again at 1 year follow up.
Multiple Sclerosis Walking Scale 12 (MSWS-12)
Questionnaire assessing the impact of the disease on walking. Each question is scored from 1-5 and then summed and transformed to a 0-100 scale. Higher scores indicate a greater impact on walking.
Time frame: Baseline, 24 weeks, after 1 year intervention, and again at 1 year follow up.
Modified Fatigue Impact Scale (MFIS)
Questionnaire assessing the effects of fatigue on physical, cognitive and psychosocial functioning. The score of the MFIS is the sum of the scores for the 21 items. A higher score represents a higher impact of fatigue, in general or in relation to one of the above mentioned areas.
Time frame: Baseline, 24 weeks, after 1 year intervention, and again at 1 year follow up.
Number of lesions
Number of lesions, measured by MRI-scanning.
Time frame: Baseline, 24 weeks, after 1 year intervention, and again at 1 year follow up.
Lesion load
Volume of lesions, measured by MRI-scanning.
Time frame: Baseline, 24 weeks, after 1 year intervention, and again at 1 year follow up.
Kurtosis
MRI-measure of microstructural changes in the brain
Time frame: Baseline, 24 weeks, after 1 year intervention, and again at 1 year follow up.
Inflammation
Blood samples will be analyzed for key inflammatory cytokines
Time frame: Baseline, 24 weeks, after 1 year intervention, and again at 1 year follow up.
Plan to share: Yes — All data will be stored in The Danish National Archives after completion of the project, and data can be accessed through request to The Danish National Archives.
Time frame: The data will become available after completion of the project, expectedly January 2021. The Danish National Archives stores data without a time frame (forever).
Access criteria: Sharing of data can happen upon request to The Danish National Archives.
Ran from Apr 2018 to primary completion in Dec 2021, 44 months.
Of 847 non-industry interventional studies with no phase under Multiple Sclerosis, half reached primary completion within 22 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 43. This study's 44 months is above that.
Counting every sponsor, half of 869 studies reached it within 21 months; a quarter within 9 and three quarters within 43.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Feb 2021. You cannot join it, but the record below documents what was studied.
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