Randomized Controlled Trial Investigating the Effects of a Standardized Aerobic Exercise Intervention on Cognitive Function and Brain Connectivity in Relapsing-remitting Multiple Sclerosis

CompletedNot a drug-phase studyRelapsing MSNCT02005237

What it found

Paper found, not read

A paper reports the results; we have not read it yet. See Papers below.

What was tested

Treatment tested

  • Aerobic Exercise

What it measured

Main measures

  • Change in Verbal Learning and Memory

    Baseline and at Month 3 (end of intervention)

    Thinking and memory

Other measures (3)

  • Change in Functional Connectivity

    Baseline and at Month 3 (end of intervention)

    MRI lesionsNerve conduction tests
  • Change in Structural Connectivity

    Baseline and at Month 3 (end of intervention)

    MRI lesionsNerve conduction tests
  • Change in Neuropsychological Function

    Baseline and at Month 3 (end of intervention)

    Thinking and memory

Who could take part

Relapsing MS · 18 to 65 · EDSS 0 to 3.5

Show the full criteria

Inclusion criteria

* Relapsing-remitting multiple sclerosis according to McDonald criteria * Currently in remission * Disease duration \< 10 years * Low to moderate physical disability (EDSS 0-3.5) * On stable immunotherapy (>3 months) or without any planned treatment for the next year

Exclusion criteria

* Patients who are not able to understand the study concept due to severe cognitive deficits or psychiatric comorbidity * Patients currently taking psychoactive drugs * Patients unable to undergo aerobic exercise training for medical reasons * Patients with active disease or uncertain stability under current immunomodulatory therapy (as judged by the treating neurologist) * Patients with implants or body modifications (e.g. dental implants, piercings, tattoos, pacemakers etc.) which might interfere with MEG and MRI assessments * Patients unable to travel to the study center 2-3 times a week for the duration of the study

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

About this trial

In the sponsor's words

Cognitive dysfunction is frequent in patients with multiple sclerosis (MS) and to date, there are no available treatments to improve cognition in this patient population. Some evidence from animal studies and small clinical trials suggest that aerobic exercise might beneficially affect cognitive function in MS. The aim of this randomized-controlled trial is to explore if an aerobic exercise training program can enhance cognition in MS. In addition, we will employ neuroimaging markers to determine if exercise alters measures of brain structure and function. Patients will be randomly assigned to either a 3-months exercise program (bicycle ergometry, 2-3 session per week) or a waitlist control group. The primary endpoint of the study is a test of verbal learning and memory. Secondary endpoints include neuroimaging markers of functional and structural connectivity in the brain. We hypothesize that exercise will improve verbal learning and memory and beneficially affect measures of brain connectivity.

Papers

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History

    1. Started

      Dec 2013

    2. Main results due

      May 2016

    3. Finished

      Nov 2016

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