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Aerobic Exercise and Brain Health in Multiple Sclerosis

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ClinicalTrials.gov Identifier: NCT02661555
Recruitment Status : Recruiting
First Posted : January 22, 2016
Last Update Posted : October 25, 2016
Sponsor:
Collaborators:
Jascha fund
Knud and Edith Eriksens memorial fund
University of Southern Denmark
Augustinus fund
Masku Neurological Center
Information provided by (Responsible Party):
University of Aarhus

Brief Summary:

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.


Condition or disease Intervention/treatment
Multiple Sclerosis Brain Atrophy Cognitive Impairment Other: Aerobic exercise

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  (Clinical Trial)
Estimated Enrollment : 85 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effects of Aerobic Exercise on Brain Health in People With Multiple Sclerosis
Study Start Date : January 2016
Estimated Primary Completion Date : May 2018
Estimated Study Completion Date : September 2018

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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.



Primary Outcome Measures :
  1. Percentage brain volume change [ Time Frame: 0, 24 and 48 weeks ]

Secondary Outcome Measures :
  1. Cognition measured by the Brief Repeatable Battery of Neuropsychological Tests [ Time Frame: 0, 24 and 48 weeks ]
  2. Blood samples: Cytokines and neurotrophins [ Time Frame: 0, 24 and 48 weeks ]
    brain derived neurotrophic factor and key cytokines

  3. VO2max [ Time Frame: 0, 24 and 48 weeks ]
  4. Percentage hippocampus volume change [ Time Frame: 0, 24 and 48 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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%

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): NCT02661555


Contacts
Contact: Martin L Christensen, MSc (+45) 87168491 mach@ph.au.dk
Contact: Ulrik Dalgas, PhD (+45) 87168176 dalgas@ph.au.dk

Locations
Denmark
Sport Science, Department of Public Health, Aarhus University Recruiting
Aarhus, Aarhus C, Denmark, 8000
Contact: Martin Langeskov-Christensen, MSc    +45 87168491    mach@adm.au.dk   
Sponsors and Collaborators
University of Aarhus
Jascha fund
Knud and Edith Eriksens memorial fund
University of Southern Denmark
Augustinus fund
Masku Neurological Center
Investigators
Principal Investigator: Martin L Christensen, MSc University of Aarhus

Responsible Party: University of Aarhus
ClinicalTrials.gov Identifier: NCT02661555     History of Changes
Other Study ID Numbers: Brain health in MS
First Posted: January 22, 2016    Key Record Dates
Last Update Posted: October 25, 2016
Last Verified: October 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Sclerosis
Multiple Sclerosis
Cognitive Dysfunction
Atrophy
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Cognition Disorders
Neurocognitive Disorders
Mental Disorders
Pathological Conditions, Anatomical