Exercise as a Supplemental Treatment Strategy Early in the Disease Course of Multiple Sclerosis

CompletedNot a drug-phase studyRelapsing MSNCT03322761

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

  • Systematic exercise training

Compared with

  • Educational program

What it measured

Main measures

  • Change in Annual Relapse Rate (ARR)

    ARR, 1 year intervention; 1 year follow up.

    Relapses
  • Percentage brain volume change

    Baseline, 24 weeks, after 1 year intervention, and again at 1 year follow up.

    MRI lesionsBrain volume loss

Other measures (2)

  • Multiple Sclerosis Functional Composite (MSFC)

    Baseline, 24 weeks, after 1 year intervention, and again at 1 year follow up.

    Disability progressionThinking and memoryWalking and mobility
  • Expanded Disability Status Scale (EDSS) score

    Baseline, after 1 year intervention, and again at 1 year follow up.

    Disability progression

Who could take part

Relapsing MS · 18 to 60

Show the full criteria

Inclusion criteria

* Signed consent * Definite diagnosis with Relapsing remitting multiple sclerosis (RRMS) * No more than 2 years since diagnosis * Expectedly able to carry out high intensity aerobic training * Able to transport themselves to and from training sessions

Exclusion criteria

* Pregnancy * Dementia, alcohol abuse, or pacemaker * Metallic implants, hindering MRI-scans * Comorbidities hindering participation in high intensity aerobic training

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

About this trial

In the sponsor's words

This study seeks to investigate whether early exercise efforts can expand the use of exercise in Multiple sclerosis (MS), from symptom treatment only, to early supplementary disease-modifying treatment. The study will be conducted in a randomized and controlled manner, with single blinding. Participants will be allocated to either a systematic aerobic exercise intervention or an educational programme on exercise and physical activity. Both interventions will last 1 year, and involve a 1 year follow-up period. It is hypothesized that early exercise efforts can modify the disease activity and disability progression.

Papers

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History

    1. Started

      Apr 2018

    2. Main results due

      Dec 2021

    3. Finished

      Dec 2021

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