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

NCT02005237 | Completed DMC

• 2 other identifiers: AERCONN031A130
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

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.

Conditions

Multiple Sclerosis

Keywords

Exercise; Cognition; Neuroimaging; Rehabilitation; Connectivity

Outcome Measures

Primary Outcomes (1)

• Change in Verbal Learning and Memory

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

  Baseline and at Month 3 (end of intervention)

Secondary Outcomes (3)

• Change in Functional Connectivity

  Baseline and at Month 3 (end of intervention)

• Change in Structural Connectivity

  Baseline and at Month 3 (end of intervention)

• Change in Neuropsychological Function

  Baseline and at Month 3 (end of intervention)

Other Outcomes (2)

• Change in Patient-Reported Outcomes

  Baseline and at Month 3 (end of intervention)

• Change in Walking Ability

  Baseline and at Month 3 (end of intervention)

Study Arms (2)

Aerobic Exercise (12 Weeks)

EXPERIMENTAL

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

Waitlist Control Group

NO INTERVENTION

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

Interventions

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

Aerobic Exercise (12 Weeks)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Universitätsklinikum Hamburg-Eppendorf: lead
• German Federal Ministry of Education and Research: collaborator

Study Sites (1)

University Hospital Hamburg-Eppendorf

Hamburg, 20241, Germany

Location

Related Publications (1)

• Baquet L, Hasselmann H, Patra S, Stellmann JP, Vettorazzi E, Engel AK, Rosenkranz SC, Poettgen J, Gold SM, Schulz KH, Heesen C. Short-term interval aerobic exercise training does not improve memory functioning in relapsing-remitting multiple sclerosis-a randomized controlled trial. PeerJ. 2018 Dec 12;6:e6037. doi: 10.7717/peerj.6037. eCollection 2018.

  PMID: 30581662 DERIVED

MeSH Terms

Conditions

Multiple Sclerosis; Motor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 3, 2013
• First Posted: December 9, 2013
• Study Start: December 1, 2013
• Primary Completion: May 1, 2016
• Study Completion: November 1, 2016
• Last Updated: June 26, 2017

Record last verified: 2017-06

Locations

DE (1)