Improving Cognition in People With Progressive Multiple Sclerosis Usin

Improving Cognition in People With Progressive Multiple Sclerosis: A Multi-Arm, Randomized, Blinded, Sham-Controlled Trial of Cognitive Rehabilitation and Aerobic Exercise.

CompletedNot a drug-phase studyProgressive MSNCT03679468

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

  • Cognitive Rehabilitation
  • Aerobic Exercise

Placebo

  • Sham Exercise
  • Sham Cognitive Rehabilitation

What it measured

Main measures

  • Change from baseline cognitive Information processing speed at 12 weeks and 6 months

    Baseline, 12 weeks, and 6 month

    Thinking and memoryPhysical functionFeasibility

Other measures (10)

  • Change from baseline cognitive verbal memory at 12 weeks and 6 months

    Baseline, 12 weeks, & 6 month

    Thinking and memoryPhysical functionFeasibility

  • Change from baseline cognitive visual memory at 12 weeks and 6 months

    Baseline, 12 weeks, & 6 month

    Thinking and memoryPhysical functionFeasibility

  • Change from baseline anxiety & depression, at 12 weeks and 6 months

    Baseline, 12 weeks, and 6 month

    Mood and sleep

  • Change from baseline depression, at 12 weeks and 6 months

    Baseline, 12 weeks, and 6 month

    Mood and sleep

  • Change from baseline fatigue, at 12 weeks and 6 months

    Baseline, 12 weeks, and 6 month

    Thinking and memoryFatigue

  • Change from baseline perceived deficits, at 12 weeks and 6 months

    Baseline, 12 weeks, and 6 month

    Thinking and memory

  • Change from baseline subjective impact of walking, at 12 weeks and 6 months

    Baseline, 12 weeks, and 6 month

    Walking and mobility

  • Change from baseline impact of Multiple Sclerosis, at 12 weeks and 6 months

    Baseline, 12 weeks, and 6 month

    Quality of life (reported by participants)

  • Change from baseline quality of life, at 12 weeks and 6 months

    Baseline, 12 weeks, and 6 month

    Walking and mobilityPainMood and sleepQuality of life (reported by participants)

  • Change from baseline global function, at 12 weeks and 6 months

    Baseline, 12 weeks, and 6 month

    FatigueWalking and mobilityQuality of life (reported by participants)

Who could take part

Progressive MS · 25 to 65

Show the full criteria

Inclusion criteria

* Have a confirmed diagnosis of progressive Multiple Sclerosis * Visual Acuity of 20/70 * Language comprehension, to ensure subjects have the ability to understand instructions

Exclusion criteria

* Wheelchair dependent (EDSS > 7.0) * History of central nervous system disease other than progressive MS * Steroids use within the past 3 months * Regular aerobic training (eg. bi-cycling, running, swimming or rowing) * Unwilling to travel to study sites for rehabilitation 2 times a week for 3 months

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

About this trial

In the sponsor's words

Given that up to 70% of people with secondary progressive MS are cognitively impaired, the search for effective treatments is considered a priority by people living with the disease. This proposal will address the effectiveness of cognitive rehabilitation (CR) and exercise, either alone, or in combination in this regard. A team of MS researchers has been assembled from the USA, Canada, the United Kingdom, Italy, Denmark, Germany and Belgium for this. A total of 360 people with progressive MS will make up the sample. Brain MRIs will be undertaken in a third of the sample before and after the 12 weeks of treatment to document the functional changes that are expected to occur with symptom improvement.

Papers

Loading reviews and guidelines…

History

    1. Started

      Mar 2019

    2. Main results due

      Oct 2022

    3. Finished

      Feb 2023

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