Clinical trial NCT02716701: Exercise in Multiple Sclerosis
Official title: Effects of Exercise on Brain Structure and Function in Multiple Sclerosis
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Multiple Sclerosis
Keywords: Exercise
Lead sponsor: University of Minnesota
Sponsor class: OTHER
First posted: 2016-03-23
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change from baseline in brain structure as measured by magnetic resonance imaging scans at 7 months
timeFrame: 7 months
measure: Change from baseline in brain structure as measured by magnetoencephalography (MEG) scans at 7 months
timeFrame: 7 months
Secondary outcomes:
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: VA Medical Center
state: Minnesota
Study officials:
affiliation: Minneapolis Veterans Affairs Medical Center
name: Adam F Carpenter, MD
role: PRINCIPAL_INVESTIGATOR
References: