Behavior and Activity Monitoring in Multiple Sclerosis

CompletedNot a drug-phase studyRelapsing MSNCT03244696

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

  • Step Tracking

Compared with

  • Water Tracking

What it measured

Main measures

  • Change in Cognitive Performance on a Latent Measure of Working Memory/Processing Speed

    Baseline, 3 months, and 6 months

    Thinking and memory

Other measures (8)

  • Changes in the Functional Architecture of the MS Brain during Working Memory

    Baseline and 6 months

    MRI lesionsThinking and memoryPhysical functionNerve conduction tests
  • Changes in the Functional Architecture of the MS Brain during Processing Speed

    Baseline and 6 months

    MRI lesionsThinking and memoryPhysical functionNerve conduction tests
  • Changes on a Self-Report Measure of Depression

    Baseline, 3 months, and 6 months

    Mood and sleep
  • Changes on a Self-Report Measure of Anxiety

    Baseline, 3 months and 6 months

    Mood and sleep
  • Changes on a Self-Report Measure of Perceived Stress

    Baseline, 3 months and 6 months

  • Changes on a Self-Report Measure of Quality of Life

    Baseline, 3 months and 6 months

    Quality of life (reported by participants)
  • Changes on a Self-Report Measure of Sleep Quality

    Baseline, 3 months and 6 months

    Mood and sleep
  • Changes on a Self-Report Measure of Fatigue

    Baseline, 3 months and 6 months

    Fatigue

Who could take part

Relapsing MS · 30 to 59

Show the full criteria

Inclusion criteria

* Clinically definite diagnosis of Relapsing-Remitting Multiple Sclerosis * Score higher than 23 on the Mini-Mental Status Examination (MMSE) * Expanded Disability Status Scale (EDSS) under 5.5 * Right-handed

Exclusion criteria

* Clinically isolated syndrome or progressive MS subtype * Presence of any other neurological disorders * Presence of psychiatric disorder diagnosed by a licensed mental health provider in the last two years * Clinically definite relapse or use of high dose corticosteroids within the last 30 days * Recreational drug use in the last 6 months * Without access to a smart phone or no access to the internet * Current use of accelerometer, pedometer, and/or physical activity monitoring equipment * Presence of ferromagnetic implanted devices or self-reported claustrophobia

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

About this trial

In the sponsor's words

The investigators propose to conduct a randomized 6-month intervention study comparing cognitive functioning in individuals with relapsing-remitting multiple sclerosis assigned to either a physical activity or an active water-intake control group. Individuals will complete pre-, mid- and post-assessments of cognitive, physical, and behavioral functioning.

Papers

Loading reviews and guidelines…

History

    1. Started

      Nov 2017

    2. Main results due

      Jun 2021

    3. Finished

      Jun 2021

    Assembled by software from public sources.