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Exercise in Multiple Sclerosis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02716701
Recruitment Status : Terminated (lack of funding)
First Posted : March 23, 2016
Last Update Posted : August 25, 2020
Sponsor:
Information provided by (Responsible Party):
University of Minnesota

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.

Condition or disease Intervention/treatment Phase
Multiple Sclerosis Behavioral: Exercise Group Other: Control Group Other: wristband activity tracker Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Effects of Exercise on Brain Structure and Function in Multiple Sclerosis
Study Start Date : January 2016
Actual Primary Completion Date : August 12, 2020
Actual Study Completion Date : August 13, 2020

Resource links provided by the National Library of Medicine


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: Control Group
Other: wristband activity tracker



Primary Outcome Measures :
  1. 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.

  2. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02716701


Locations
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United States, Minnesota
VA Medical Center
Minneapolis, Minnesota, United States, 55417
Sponsors and Collaborators
University of Minnesota
Investigators
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Principal Investigator: Adam F Carpenter, MD Minneapolis Veterans Affairs Medical Center
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Responsible Party: University of Minnesota
ClinicalTrials.gov Identifier: NCT02716701    
Other Study ID Numbers: 4607-B
First Posted: March 23, 2016    Key Record Dates
Last Update Posted: August 25, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Minnesota:
Exercise
Additional relevant MeSH terms:
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Multiple Sclerosis
Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases