Exercise in Multiple Sclerosis

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.

Study Overview

• Status: Terminated
• Conditions: Multiple Sclerosis
• Intervention / Treatment: Behavioral: Exercise Group; Other: wristband activity tracker; Other: Control Group

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.

• Study Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Minneapolis, Minnesota, United States, 55417
      • VA Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: BASIC_SCIENCE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Exercise Group; Subjects will wear a wristband activity tracker to monitor their physical activity and will be asked to increase their activity level, with a goal of at least doubling their average daily activity (steps)	Behavioral: Exercise Group; Other: wristband activity tracker
ACTIVE_COMPARATOR: Control Group; Subjects will wear a wristband activity tracker to monitor their physical activity and will not be encouraged to increase their activity level	Other: wristband activity tracker; Other: Control Group

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline in brain structure as measured by magnetic resonance imaging scans at 7 months	Magnetic resonance imaging (MRI) scans will be done at 1 month (baseline) and 7 months after subjects begin wearing a wristband activity tracker.	7 months
Change from baseline in brain structure as measured by magnetoencephalography (MEG) scans at 7 months	MEG scans will be done at 1 month (baseline) and 7 months after subjects begin wearing a wristband activity tracker	7 months

Collaborators and Investigators

• Sponsor: University of Minnesota
• Investigators: Principal Investigator: Adam F Carpenter, MD, Minneapolis Veterans Affairs Medical Center

Study record dates

Study Major Dates

• Study Start: January 1, 2016
• Primary Completion (ACTUAL): August 12, 2020
• Study Completion (ACTUAL): August 13, 2020

Study Registration Dates

• First Submitted: March 10, 2016
• First Submitted That Met QC Criteria: March 17, 2016
• First Posted (ESTIMATE): March 23, 2016

Study Record Updates

• Last Update Posted (ACTUAL): August 25, 2020
• Last Update Submitted That Met QC Criteria: August 20, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Keywords: Exercise
• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Multiple Sclerosis; Sclerosis
• Other Study ID Numbers: 4607-B

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No