Effects of Exercise on Brain Structure and Function in Multiple Sclerosis

Stopped earlyNot a drug-phase studyMS (type not specified)NCT02716701

What it found

Stopped

The trial ended early for another reason (see below).

Reason given: lack of funding

This trial finished 6 years ago. We found no results in the registry or in any paper that cites it.

What was tested

Treatment tested

  • Exercise Group

Compared with

  • Control Group

Given to everyone in the trial

  • wristband activity tracker

What it measured

Main measures

  • Change from baseline in brain structure as measured by magnetic resonance imaging scans at 7 months

    7 months

    MRI lesions
  • Change from baseline in brain structure as measured by magnetoencephalography (MEG) scans at 7 months

    7 months

Who could take part

MS (type not specified) · 18 to 100 · EDSS 0 to 6.0

Show the full 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

As registered. Criteria can change, so ask the trial team or your neurologist.

About this trial

In the sponsor's words

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.

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History

    1. Started

      Jan 2016

    2. Main results due

      Aug 2020

    3. Finished

      Aug 2020

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