Exercise in Multiple Sclerosis

NCT ID: NCT02716701

Last Updated: 2020-08-25

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-01-31
• Study Completion Date: 2020-08-13

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.

Conditions

Multiple Sclerosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

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)

Group Type: EXPERIMENTAL

Exercise Group

Intervention Type: BEHAVIORAL

wristband activity tracker

Intervention Type: OTHER

Control Group

Subjects will wear a wristband activity tracker to monitor their physical activity and will not be encouraged to increase their activity level

Group Type: ACTIVE_COMPARATOR

Control Group

Intervention Type: OTHER

wristband activity tracker

Intervention Type: OTHER

Interventions

Exercise Group

Intervention Type: BEHAVIORAL

Control Group

Intervention Type: OTHER

wristband activity tracker

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Minnesota

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Adam F Carpenter, MD

Role: PRINCIPAL_INVESTIGATOR

Minneapolis Veterans Affairs Medical Center

Locations

VA Medical Center

Minneapolis, Minnesota, United States

Countries

United States

Other Identifiers

4607-B

Identifier Type: -

Identifier Source: org_study_id