Exercise in Multiple Sclerosis



Status:Active, not recruiting
Conditions:Neurology, Neurology, Multiple Sclerosis
Therapuetic Areas:Neurology, Other
Healthy:No
Age Range:18 - 100
Updated:3/27/2019
Start Date:January 2016
End Date:December 2019

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Effects of Exercise on Brain Structure and Function in Multiple Sclerosis

Exercise therapy in MS patients has proven benefits on mobility, mood, motor function and
quality of life. While the beneficial effects of exercise on cardiovascular and
musculoskeletal function are well known, there has recently been increased focus on the
positive effects of exercise on brain structure and function. The goal of this study is to
determine whether exercise can promote beneficial changes in brain function in MS patients.

Multiple Sclerosis (MS) is a chronic, disabling neurologic disease characterized by damage to
myelin and axons in the central nervous system (CNS). Current therapy for MS primarily
consists of immunomodulatory drugs aimed at preventing future CNS injury; no treatments are
currently available to repair existing damage, and symptomatic treatments to improve
neurological function are quite limited. Rehabilitation approaches, such as exercise, have
long been a staple of MS therapy. Exercise therapy in MS patients has proven benefits on
mobility, mood, motor function and quality of life. While the beneficial effects of exercise
on cardiovascular and musculoskeletal function are well known, there has recently been
increased focus on the positive effects of exercise on brain structure and function. The
overall aim of this proposal is to determine whether exercise can promote beneficial changes
in brain function in MS patients. The investigator's central hypothesis is that
cardiovascular exercise alters both brain structure and brain function in MS patients, and
that these changes can be identified and monitored via imaging techniques that evaluate
regional brain volumes and functional connectivity. When brain activity measured at one area
fluctuates in a coherent manner with that recorded in a different area, those brain regions
are considered to be functionally connected. Using resting-state magnetoencephalography
(MEG), the investigator's laboratory has demonstrated that these patterns of correlated brain
activity are abnormal in MS patients.

Inclusion Criteria:

- Male or female patients with a confirmed diagnosis of MS by revised McDonald criteria

- Age ≥ 18 years

- Expanded Disability Status Scale (EDSS) 0-6.0, inclusive.

- Able to understand the consent process, and the use of the wristband activity tracker.

- Sedentary by self-report (answers no to the question: "Do you exercise regularly?"

- Willing to make sincere effort to comply with the study objective of increasing their
physical activity as much as possible (with goal of at least 100% increase) and to
maintain that increased activity level for six months (if randomized to the exercise
group).

Exclusion Criteria:

- Current serious medical condition which would likely limit subject's ability to
achieve sustained increase in physical activity, or put them at risk for doing so in
the investigators' opinion (e.g. significant cardiovascular or respiratory disease,
cancer, cancer, orthopedic disease, etc)

- Subjects that have a central nervous system disorder (in addition to MS) that is not
considered secondary to MS

- Subjects that have implanted metal, pacemaker, etc. that may interfere with the
MEG/MRI scan or who are otherwise unable to complete the MEG/MRI scan procedure
without sedation (e.g. due to claustrophobia, obesity)

- weight > 300 pounds
We found this trial at
1
site
Minneapolis, Minnesota 55417
Principal Investigator: Adam F Carpenter, MD
?
mi
from
Minneapolis, MN
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