Improving Cognition in People With Progressive Multiple Sclerosis Using Aerobic Exercise and Cognitive Rehabilitation

NCT03679468 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 309

Last updated 2023-11-08

No results posted yet for this study

Summary

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.

Conditions

Interventions

OTHER

Cognitive Rehabilitation

RehaCom software Information processing speed and attention modules

OTHER

Sham Exercise

Sets of balance and stretching exercises

OTHER

Sham Cognitive Rehabilitation

Kompozer software 24 session module consisting of basic internet searches

OTHER

Aerobic Exercise

Recumbent NuStep Bike Aerobic cycling

Sponsors & Collaborators

  • University of Florence

    collaborator OTHER
  • Fondazione Italiana Sclerosi Multipla

    collaborator OTHER
  • University College, London

    collaborator OTHER
  • Kessler Foundation

    collaborator OTHER
  • University of Alabama at Birmingham

    collaborator OTHER
  • University of Southern Denmark

    collaborator OTHER
  • Hasselt University

    collaborator OTHER
  • University of Plymouth

    collaborator OTHER
  • Universita degli Studi di Genova

    collaborator OTHER
  • Unity Health Toronto

    collaborator OTHER
  • Ospedale San Raffaele

    collaborator OTHER
  • Sunnybrook Health Sciences Centre

    lead OTHER

Principal Investigators

  • Anthony Feinstein, MD · Sunnybrook Health Sciences Centre

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
DOUBLE
Model
SEQUENTIAL

Eligibility

Min Age
25 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-03-18
Primary Completion
2022-10-30
Completion
2023-02-03

Countries

  • Canada

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03679468 on ClinicalTrials.gov