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Exercise in Multiple Sclerosis

Primary Purpose

Multiple Sclerosis

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Exercise Group
Control Group
wristband activity tracker
Sponsored by
University of Minnesota
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Multiple Sclerosis focused on measuring Exercise

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • VA Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Exercise Group

Control Group

Arm Description

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)

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

Outcomes

Primary Outcome Measures

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.
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

Secondary Outcome Measures

Full Information

First Posted
March 10, 2016
Last Updated
August 20, 2020
Sponsor
University of Minnesota
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1. Study Identification

Unique Protocol Identification Number
NCT02716701
Brief Title
Exercise in Multiple Sclerosis
Official Title
Effects of Exercise on Brain Structure and Function in Multiple Sclerosis
Study Type
Interventional

2. Study Status

Record Verification Date
August 2020
Overall Recruitment Status
Terminated
Why Stopped
lack of funding
Study Start Date
January 2016 (undefined)
Primary Completion Date
August 12, 2020 (Actual)
Study Completion Date
August 13, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Minnesota

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis
Keywords
Exercise

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Exercise Group
Arm Type
Experimental
Arm Description
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)
Arm Title
Control Group
Arm Type
Active Comparator
Arm Description
Subjects will wear a wristband activity tracker to monitor their physical activity and will not be encouraged to increase their activity level
Intervention Type
Behavioral
Intervention Name(s)
Exercise Group
Intervention Type
Other
Intervention Name(s)
Control Group
Intervention Type
Other
Intervention Name(s)
wristband activity tracker
Primary Outcome Measure Information:
Title
Change from baseline in brain structure as measured by magnetic resonance imaging scans at 7 months
Description
Magnetic resonance imaging (MRI) scans will be done at 1 month (baseline) and 7 months after subjects begin wearing a wristband activity tracker.
Time Frame
7 months
Title
Change from baseline in brain structure as measured by magnetoencephalography (MEG) scans at 7 months
Description
MEG scans will be done at 1 month (baseline) and 7 months after subjects begin wearing a wristband activity tracker
Time Frame
7 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Adam F Carpenter, MD
Organizational Affiliation
Minneapolis Veterans Affairs Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
VA Medical Center
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55417
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Exercise in Multiple Sclerosis

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