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Exercise in Multiple Sclerosis: Effects on Cognitive Function and Brain Connectivity

NCT02005237 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 68

Last updated 2017-06-26

No results posted yet for this study

Summary

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.

Conditions

Interventions

BEHAVIORAL

Aerobic Exercise

3-months exercise program tailored to the individual level of aerobic fitness. Patients will exercise on a bicycle ergometer (2-3 session per week) according to a predefined training plan with increasing duration and intensity

Sponsors & Collaborators

  • German Federal Ministry of Education and Research

    collaborator OTHER_GOV

  • Universitätsklinikum Hamburg-Eppendorf

    lead OTHER

Principal Investigators

  • Stefan M Gold, PhD · Center for Molecular Neurobiology, University Hospital Hamburg Eppendorf

  • Andreas K Engel, MD · Dept Neurophysiology, University Hospital Hamburg Eppendorf

  • Christoph Heesen, MD · Dept Neurology, University Hospital Hamburg Eppendorf

  • Guido Nolte, PhD · Dept Neurophysiology, University Hospital Hamburg Eppendorf

  • Karl-Heinz Schulz, MD, PhD · Dept Sports Medicine, University Hospital Hamburg Eppendorf

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2013-12-31
Primary Completion
2016-05-31
Completion
2016-11-30

Countries

  • Germany

Study Locations

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Entities

Diseases

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 NCT02005237 on ClinicalTrials.gov