Exercise in Multiple Sclerosis

August 20, 2020 updated by: University of Minnesota

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

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
40

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change from baseline in brain structure as measured by magnetic resonance imaging scans at 7 months
Time Frame: 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
Time Frame: 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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Minnesota

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Adam F Carpenter, MD, Minneapolis Veterans Affairs Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2016

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 12, 2020

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 13, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 10, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 17, 2016

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 23, 2016

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 25, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 20, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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