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

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ClinicalTrials.gov Identifier: NCT02005237
Recruitment Status : Completed
First Posted : December 9, 2013
Last Update Posted : June 26, 2017
Sponsor:
Collaborator:
German Federal Ministry of Education and Research
Information provided by (Responsible Party):
Universitätsklinikum Hamburg-Eppendorf

Brief 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.


Condition or disease Intervention/treatment Phase
Multiple Sclerosis Behavioral: Aerobic Exercise Not Applicable

Detailed Description:

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 68 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Randomized Controlled Trial Investigating the Effects of a Standardized Aerobic Exercise Intervention on Cognitive Function and Brain Connectivity in Relapsing-remitting Multiple Sclerosis
Study Start Date : December 2013
Actual Primary Completion Date : May 2016
Actual Study Completion Date : November 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Aerobic Exercise (12 Weeks)
Aerobic exercise on a bicycle ergometer, tailored to the individual's level of fitness. Duration: 12 weeks with 2-3 sessions per week.
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

No Intervention: Waitlist Control Group
No intervention (patients randomized to this group will be offered access to the training program after completion of the trial)



Primary Outcome Measures :
  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 Outcome Measures :
  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 Outcome Measures:
  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



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02005237


Locations
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Germany
University Hospital Hamburg-Eppendorf
Hamburg, Germany, 20241
Sponsors and Collaborators
Universitätsklinikum Hamburg-Eppendorf
German Federal Ministry of Education and Research
Investigators
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Principal Investigator: Stefan M Gold, PhD Center for Molecular Neurobiology, University Hospital Hamburg Eppendorf
Principal Investigator: Andreas K Engel, MD Dept Neurophysiology, University Hospital Hamburg Eppendorf
Principal Investigator: Christoph Heesen, MD Dept Neurology, University Hospital Hamburg Eppendorf
Principal Investigator: Guido Nolte, PhD Dept Neurophysiology, University Hospital Hamburg Eppendorf
Principal Investigator: Karl-Heinz Schulz, MD, PhD Dept Sports Medicine, University Hospital Hamburg Eppendorf

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Universitätsklinikum Hamburg-Eppendorf
ClinicalTrials.gov Identifier: NCT02005237     History of Changes
Other Study ID Numbers: AERCONN
031A130 ( Other Grant/Funding Number: BMBF )
First Posted: December 9, 2013    Key Record Dates
Last Update Posted: June 26, 2017
Last Verified: June 2017

Keywords provided by Universitätsklinikum Hamburg-Eppendorf:
Exercise
Cognition
Neuroimaging
Rehabilitation
Connectivity

Additional relevant MeSH terms:
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Sclerosis
Multiple Sclerosis
Multiple Sclerosis, Relapsing-Remitting
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases