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NCT Number: NCT02005237

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

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.

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Key information

Conditions

Multiple Sclerosis Autoimmune Diseases Autoimmune Diseases of the Nervous System Behavior Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Immune System Diseases Motor Activity Nervous System Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital Hamburg-Eppendorf

Hamburg, 20241, Germany

About this study

Background: 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.

Aims: This study aims to explore the potential of an aerobic exercise program on brain structure and function in MS in a single-blind, randomized controlled phase IIa trial. We hypothesize that exercise will improve verbal learning and memory (primary endpoint) as well as induce changes in neuroimaging markers of structural and functional central nervous system (CNS) connectivity (secondary endpoints). Tertiary outcomes will include walking ability, motor function and coordination, as well as patient-based outcomes (depression, fatigue, and health-related quality of life).

Design: This is a single-blind, randomized, controlled phase IIa trial with a parallel group design comparing 3 months of standardized aerobic exercise training (bicycle ergometry) to a waitlist control group (superiority framework). The allocation ratio of exercise to waitlist control is 1:1 with a sample size of n=60.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Relapsing-remitting multiple sclerosis according to McDonald criteria
  • Currently in remission
  • Disease duration < 10 years
  • Low to moderate physical disability (EDSS 0-3.5)
  • On stable immunotherapy (>3 months) or without any planned treatment for the next year

Exclusion criteria

  • Patients who are not able to understand the study concept due to severe cognitive deficits or psychiatric comorbidity
  • Patients currently taking psychoactive drugs
  • Patients unable to undergo aerobic exercise training for medical reasons
  • Patients with active disease or uncertain stability under current immunomodulatory therapy (as judged by the treating neurologist)
  • Patients with implants or body modifications (e.g. dental implants, piercings, tattoos, pacemakers etc.) which might interfere with MEG and MRI assessments
  • Patients unable to travel to the study center 2-3 times a week for the duration of the study

Treatment and study plan

Aerobic Exercise

Behavioral

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

Primary outcomes

  1. Change in Verbal Learning and Memory

    Time frame: Baseline and at Month 3 (end of intervention)

    Verbal Learning and Memory will be assessed with the Verbal Learning and Memory Test (VLMT)

Secondary outcomes

  1. Change in Functional Connectivity

    Time frame: Baseline and at Month 3 (end of intervention)

    Functional connectivity of CNS networks will be assessed by resting-state functional magnetic resonance imaging (rs fMRI) and resting-state magnetoencephalography (rs MEG)

  2. Change in Structural Connectivity

    Time frame: Baseline and at Month 3 (end of intervention)

    Structural connectivity and integrity of CNS networks will be assessed by diffusion tensor imaging (DTI) as well as measures of gray matter density using magnetic resonance imaging (MRI)

  3. Change in Neuropsychological Function

    Time frame: Baseline and at Month 3 (end of intervention)

    Neuropsychological function will be assessed using a standardized battery covering the following domains: visuospatial learning and memory, attention, processing speed, working memory, and social cognition

Other outcomes

  1. Change in Patient-Reported Outcomes

    Time frame: Baseline and at Month 3 (end of intervention)

    Patient-reported outcomes will be assessed for depressive symptoms (IDS-30SR), fatigue (FSMC), quality of life (HAQUAMS), and walking (MSWS-12)

  2. Change in Walking Ability

    Time frame: Baseline and at Month 3 (end of intervention)

    Walking ability will be assessed using the six-minute-walk test (6MWT) as well as Actibelt accelerometry

Sponsors and collaborators

Lead sponsor

Universitätsklinikum Hamburg-Eppendorf

Other

Collaborators

  • German Federal Ministry of Education and Research

Registry information

Official study title

Randomized Controlled Trial Investigating the Effects of a Standardized Aerobic Exercise Intervention on Cognitive Function and Brain Connectivity in Relapsing-remitting Multiple Sclerosis

Acronym: AERCONN

Important dates

Study start
2013
Primary completion
2016
Study completion
2016
First posted
Dec 9, 2013
Registry last updated
Jun 26, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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