NCT02661555

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
86

participants targeted

Target at P75+ for not_applicable multiple-sclerosis

Timeline
Completed

Started Jan 2016

Longer than P75 for not_applicable multiple-sclerosis

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2016

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

January 15, 2016

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 22, 2016

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2018

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2019

Completed
Last Updated

June 3, 2021

Status Verified

May 1, 2018

Enrollment Period

2.6 years

First QC Date

January 15, 2016

Last Update Submit

May 28, 2021

Conditions

Multiple SclerosisBrain AtrophyCognitive Impairment

Outcome Measures

Primary Outcomes (1)

  • Percentage brain volume change

    0, 24 and 48 weeks

Secondary Outcomes (11)

  • Cognition measured by the Brief Repeatable Battery of Neuropsychological Tests

    0, 24 and 48 weeks

  • Blood samples: Cytokines and neurotrophins

    0, 24 and 48 weeks

  • VO2max

    0, 24 and 48 weeks

  • Regional volume change changes (e.g. hippocampus, thalamus)

    0, 24 and 48 weeks

  • Modified Fatigue Impact Scale

    0, 24 and 48 weeks

  • +6 more secondary outcomes

Study Arms (2)

Aerobic exercise

EXPERIMENTAL

Aerobic exercise two times per week for 24 weeks.

Other: Aerobic exercise

Habitual lifestyle

NO INTERVENTION

Habitual lifestyle the first 24 weeks. Will be offered the same exercise intervention after 24 weeks.

Interventions

Aerobic exerciseOTHER
Aerobic exercise

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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%

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sport Science, Department of Public Health, Aarhus University

Aarhus, Aarhus C, 8000, Denmark

Location

Related Publications (3)

  • Kupjetz M, Langeskov-Christensen M, Riemenschneider M, Inerle S, Ligges U, Gaemelke T, Patt N, Bansi J, Gonzenbach RR, Reuter M, Rosenberger F, Meyer T, McCann A, Ueland PM, Eskildsen SF, Nygaard MKE, Joisten N, Hvid L, Dalgas U, Zimmer P. Persons With Multiple Sclerosis Reveal Distinct Kynurenine Pathway Metabolite Patterns: A Multinational Cross-Sectional Study. Neurol Neuroimmunol Neuroinflamm. 2025 Nov;12(6):e200461. doi: 10.1212/NXI.0000000000200461. Epub 2025 Sep 18.

    PMID: 40966534DERIVED

  • Langeskov-Christensen M, Grondahl Hvid L, Nygaard MKE, Ringgaard S, Jensen HB, Nielsen HH, Petersen T, Stenager E, Eskildsen SF, Dalgas U. Efficacy of High-Intensity Aerobic Exercise on Brain MRI Measures in Multiple Sclerosis. Neurology. 2021 Jan 12;96(2):e203-e213. doi: 10.1212/WNL.0000000000011241. Epub 2020 Dec 1.

    PMID: 33262230DERIVED

  • Langeskov-Christensen M, Hvid LG, Jensen HB, Nielsen HH, Petersen T, Stenager E, Hamalainen P, Dalgas U. Efficacy of high-intensity aerobic exercise on cognitive performance in people with multiple sclerosis: A randomized controlled trial. Mult Scler. 2021 Sep;27(10):1585-1596. doi: 10.1177/1352458520973619. Epub 2020 Nov 24.

    PMID: 33232191DERIVED

MeSH Terms

Conditions

Multiple SclerosisCognitive Dysfunction

Interventions

Exercise

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesAutoimmune DiseasesImmune System DiseasesCognition DisordersNeurocognitive DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Martin L Christensen, MSc

    University of Aarhus

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 15, 2016

First Posted

January 22, 2016

Study Start

January 1, 2016

Primary Completion

August 1, 2018

Study Completion

May 1, 2019

Last Updated

June 3, 2021

Record last verified: 2018-05

Data Sharing

IPD Sharing
Will not share

Locations

DK(1)