Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT02661555 |
| Other study ID # |
Brain health in MS |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
January 2016 |
| Est. completion date |
May 2019 |
Study information
| Verified date |
May 2018 |
| Source |
University of Aarhus |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
The purpose of the project is to investigate how aerobic exercise affects brain volume,
specific brain regions, neurotrophins and cognition in patients with multiple sclerosis.
The study will be a single blinded randomized controlled trial with a 6 months intervention.
It is hypothesized that aerobic exercise can slow down brain atrophy, increase the size of
hippocampus, upregulate the secretion of neurotrophins and improve cognitive performance in
people with multiple sclerosis.
Description:
Multiple Sclerosis (MS) is a physically and cognitively disabling, chronic autoimmune disease
of unknown etiology. It is the most common neurological disease affecting young adults in
Western countries. According to the Danish MS Registry the prevalence has increased markedly
over the last 40 years for particularly women, and today there are approximately 14.000
patients with MS (PwMS) in Denmark.
The pathological hallmark of MS is sclerotic plaque. Plaques in the central nervous system
(CNS) can be detected in vivo using magnetic resonance imaging (MRI). Both the accumulation
of lesions and the accelerated whole-brain atrophy correlate with the progressing physical
and cognitive disabilities that clinically characterize PwMS.
The disease causes damage of both white and grey matter in the CNS, leading to whole brain
atrophy and topographically specific atrophy within the hippocampus and the frontal and
temporal cortices. The degradation of the CNS manifests as cognitive and physical disability.
Cognitive impairment is estimated to affect up to 65% of PwMS, making it one of the most
common and disabling symptoms of MS. Medical therapies for cognitive impairment in MS have so
far proved ineffective. Collectively, the prevalence, impact and missing treatments highlight
the importance of alternative approaches towards preservation of cognitive function. Despite
equivocal findings, aerobic exercise represents a promising approach towards preservation or
even expansion of hippocampal volume and cognitive functioning in MS. No longitudinal
randomized controlled trial (RCT) study has so far applied the MRI technique when evaluating
the potential neuro-protective effect of exercise on brain structure and function in MS.
Also, given the scarcity of effective treatments for cognitive impairment in MS, a
longitudinal exercise intervention evaluating the potential effect of aerobic exercise on
cognition is urgently needed in MS.
The purpose of the present project is to investigate how aerobic exercise affects brain
volume, specific brain regions, neurotrophins and cognition in PwMS.
It is hypothesized that aerobic exercise can slow down brain atrophy, increase the size of
hippocampus, upregulate the secretion of neurotrophins and improve cognitive performance in
people with MS.
The study will be a single blinded RCT. The exercise intervention will contain 6 months of
aerobic training (bicycling, rowing and cross trainer) performed two times a week at moderate
to high intensity and under supervision. The control group will be "living as usual" and will
be offered the same exercise intervention after a 6 month period. A total of approximately 85
PwMS will be expected to be enrolled. The primary outcome of the study will be brain atrophy
determined by MRI.
The current interdisciplinary project aims to document and understand the possible
neuro-protective effects of exercise in MS. This would be of high relevance to PwMS (and
other neurological pathologies). From a societal perspective it would help optimize MS
rehabilitation and subsequently reduce MS related costs due to disability. In case of
positive findings, this would provide the first convincing human evidence of a disease
modifying effect of exercise in MS.
