Aerobic Exercise and Brain Health in Multiple Sclerosis

May 28, 2021 updated by: University of Aarhus

Effects of Aerobic Exercise on Brain Health in People With Multiple Sclerosis

The purpose of the project is to investigate how aerobic exercise affects brain volume, specific brain regions, neurotrophins and cognition in patients with multiple sclerosis.

The study will be a single blinded randomized controlled trial with a 6 months intervention.

It is hypothesized that aerobic exercise can slow down brain atrophy, increase the size of hippocampus, upregulate the secretion of neurotrophins and improve cognitive performance in people with multiple sclerosis.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Multiple Sclerosis (MS) is a physically and cognitively disabling, chronic autoimmune disease of unknown etiology. It is the most common neurological disease affecting young adults in Western countries. According to the Danish MS Registry the prevalence has increased markedly over the last 40 years for particularly women, and today there are approximately 14.000 patients with MS (PwMS) in Denmark.

The pathological hallmark of MS is sclerotic plaque. Plaques in the central nervous system (CNS) can be detected in vivo using magnetic resonance imaging (MRI). Both the accumulation of lesions and the accelerated whole-brain atrophy correlate with the progressing physical and cognitive disabilities that clinically characterize PwMS.

The disease causes damage of both white and grey matter in the CNS, leading to whole brain atrophy and topographically specific atrophy within the hippocampus and the frontal and temporal cortices. The degradation of the CNS manifests as cognitive and physical disability. Cognitive impairment is estimated to affect up to 65% of PwMS, making it one of the most common and disabling symptoms of MS. Medical therapies for cognitive impairment in MS have so far proved ineffective. Collectively, the prevalence, impact and missing treatments highlight the importance of alternative approaches towards preservation of cognitive function. Despite equivocal findings, aerobic exercise represents a promising approach towards preservation or even expansion of hippocampal volume and cognitive functioning in MS. No longitudinal randomized controlled trial (RCT) study has so far applied the MRI technique when evaluating the potential neuro-protective effect of exercise on brain structure and function in MS. Also, given the scarcity of effective treatments for cognitive impairment in MS, a longitudinal exercise intervention evaluating the potential effect of aerobic exercise on cognition is urgently needed in MS.

The purpose of the present project is to investigate how aerobic exercise affects brain volume, specific brain regions, neurotrophins and cognition in PwMS.

It is hypothesized that aerobic exercise can slow down brain atrophy, increase the size of hippocampus, upregulate the secretion of neurotrophins and improve cognitive performance in people with MS.

The study will be a single blinded RCT. The exercise intervention will contain 6 months of aerobic training (bicycling, rowing and cross trainer) performed two times a week at moderate to high intensity and under supervision. The control group will be "living as usual" and will be offered the same exercise intervention after a 6 month period. A total of approximately 85 PwMS will be expected to be enrolled. The primary outcome of the study will be brain atrophy determined by MRI.

The current interdisciplinary project aims to document and understand the possible neuro-protective effects of exercise in MS. This would be of high relevance to PwMS (and other neurological pathologies). From a societal perspective it would help optimize MS rehabilitation and subsequently reduce MS related costs due to disability. In case of positive findings, this would provide the first convincing human evidence of a disease modifying effect of exercise in MS.

Study Type

Interventional

Enrollment (Actual)

86

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
    • Aarhus C
      • Aarhus, Aarhus C, Denmark, 8000
        • Sport Science, Department of Public Health, Aarhus University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Signed consent
  • Definite MS diagnosis
  • Be clarified with the diagnosis and treatment
  • Expectedly able to carry out the aerobic training / test
  • Expanded Disability Status Scale (EDSS) score ≤6.0
  • Must be able to transport themselves to and from training sessions

Exclusion Criteria:

  • Dementia, alcohol abuse or pacemaker
  • Medical comorbidity such as cardiovascular, respiratory, orthopedic or metabolic disorders or other concurrent diseases causing disability and hindering participation in the intervention
  • Disease relapse in a 8 week period prior to study start
  • Pregnancy
  • Metallic implants hindering the MRI scans.
  • Expected training attendance below 85%

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Aerobic exercise
Aerobic exercise two times per week for 24 weeks.
Other: Aerobic exercise
No Intervention: Habitual lifestyle
Habitual lifestyle the first 24 weeks. Will be offered the same exercise intervention after 24 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Percentage brain volume change
Time Frame: 0, 24 and 48 weeks
0, 24 and 48 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cognition measured by the Brief Repeatable Battery of Neuropsychological Tests
Time Frame: 0, 24 and 48 weeks
0, 24 and 48 weeks
Blood samples: Cytokines and neurotrophins
Time Frame: 0, 24 and 48 weeks
brain derived neurotrophic factor and key cytokines
0, 24 and 48 weeks
VO2max
Time Frame: 0, 24 and 48 weeks
0, 24 and 48 weeks
Regional volume change changes (e.g. hippocampus, thalamus)
Time Frame: 0, 24 and 48 weeks
0, 24 and 48 weeks
Modified Fatigue Impact Scale
Time Frame: 0, 24 and 48 weeks
Lower score is better. Range 0-84
0, 24 and 48 weeks
Fatigue Severity Scale
Time Frame: 0, 24 and 48 weeks
Lower score is better. Range 9-63.
0, 24 and 48 weeks
Major Depression Inventory
Time Frame: 0, 24 and 48 weeks
Lower score is better. Range 0-50
0, 24 and 48 weeks
Short Form 36
Time Frame: 0, 24 and 48 weeks
Higher score is better. Each item is scored on a 0 to 100 range.
0, 24 and 48 weeks
Multiple Sclerosis Impact Scale 29
Time Frame: 0, 24 and 48 weeks
Converted to a 0-100 scale where 100 indicates greater impact of disease on daily function
0, 24 and 48 weeks
6-min walk test
Time Frame: 0, 24 and 48 weeks
Walk as far as possible in 6 minutes. Higher is better.
0, 24 and 48 weeks
Six Spot Step Test
Time Frame: 0, 24 and 48 weeks
Complete the task as fast as possible. Faster is better.
0, 24 and 48 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Aarhus

Collaborators

University of Southern Denmark
Jascha fund
Knud and Edith Eriksens memorial fund
Augustinus fund
Masku Neurological Center

Investigators

  • Principal Investigator: Martin L Christensen, MSc, University of Aarhus

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2016

Primary Completion (Actual)

August 1, 2018

Study Completion (Actual)

May 1, 2019

Study Registration Dates

First Submitted

January 15, 2016

First Submitted That Met QC Criteria

January 20, 2016

First Posted (Estimate)

January 22, 2016

Study Record Updates

Last Update Posted (Actual)

June 3, 2021

Last Update Submitted That Met QC Criteria

May 28, 2021

Last Verified

May 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Brain health in MS

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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