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TerminatedNCT02716701Updated Aug 25, 2020

Exercise in Multiple Sclerosis

An interventional study of Exercise Group and Control Group in Multiple Sclerosis, sponsored by University of Minnesota. Terminated at 1 site in United States. Open to participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2020-08-25.

Sponsored by University of Minnesota · Not applicable, Interventional, and Basic science

Why this study was terminated
lack of funding
Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
18 Years to 100 Years
Sex
All
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Study 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.

Read the 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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Conditions studied

  • Multiple Sclerosis

Keywords

  • Exercise
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In context

Multiple Sclerosis

3,460 studies on the registry are indexed under Multiple Sclerosis; 661 are open to participants now.

This study's planned enrollment of 40 is below the median of 50 across 2,342 interventional studies indexed under Multiple Sclerosis.

Browse Multiple Sclerosis studies →

Lead sponsor

University of Minnesota is the lead sponsor of 1,184 studies on the registry; 195 are open to participants now.

Of its 132 completed or terminated interventional studies of FDA-regulated products, 91 (69%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 100 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
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Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
40 participants (estimated)

Study arms

  • 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

Interventions

  • BehavioralExercise Group
  • OtherControl Group
  • Otherwristband activity tracker
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What researchers measure

Primary outcomes

  1. 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.

    Time frame: 7 months

  2. 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

    Time frame: 7 months

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Study locations

1 site
  • VA Medical Center
    Minneapolis, Minnesota 55417, United States
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 25, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02716701
Lead sponsor
University of Minnesota
Responsible party
Sponsor
First posted
Mar 23, 2016
Start date
Jan 2016
Primary completion
Aug 12, 2020
Completion
Aug 13, 2020
Last update
Aug 25, 2020

Study contacts

Adam F Carpenter, MD
principal investigator · Minneapolis Veterans Affairs Medical Center

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is terminated, as verified in Aug 2020. You cannot join it, but the record below documents what was studied.

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