Early Exercise Efforts in Multiple Sclerosis

NCT03322761 | Completed DMC

• 1 other identifier: Morten_Riemenschneider_PhD
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

Brief Summary

This study seeks to investigate whether early exercise efforts can expand the use of exercise in Multiple sclerosis (MS), from symptom treatment only, to early supplementary disease-modifying treatment. The study will be conducted in a randomized and controlled manner, with single blinding. Participants will be allocated to either a systematic aerobic exercise intervention or an educational programme on exercise and physical activity. Both interventions will last 1 year, and involve a 1 year follow-up period. It is hypothesized that early exercise efforts can modify the disease activity and disability progression.

Conditions

Multiple Sclerosis

Keywords

Multiple sclerosis; Exercise; Disease-modifying treatment; Early treatment

Outcome Measures

Primary Outcomes (2)

• Change in Annual Relapse Rate (ARR)

  Number of relapses, registered and validated by neurologist, on annual basis

  ARR, 1 year intervention; 1 year follow up.

• Percentage brain volume change

  Brain atrophy will be measured from MRI-scans

  Baseline, 24 weeks, after 1 year intervention, and again at 1 year follow up.

Secondary Outcomes (2)

• Multiple Sclerosis Functional Composite (MSFC)

  Baseline, 24 weeks, after 1 year intervention, and again at 1 year follow up.

• Expanded Disability Status Scale (EDSS) score

  Baseline, after 1 year intervention, and again at 1 year follow up.

Other Outcomes (15)

• Functional capacity, Six-minute walk test (6MWT)

  Baseline, 24 weeks, after 1 year intervention, and again at 1 year follow up.

• Functional capacity, Six-spot-step-test (SSST)

  Baseline, 24 weeks, after 1 year intervention, and again at 1 year follow up.

• Functional capacity, Accelerometry

  Baseline, 24 weeks, after 1 year intervention, and again at 1 year follow up.

Study Arms (3)

Systematic exercise training

EXPERIMENTAL

Two weekly supervised aerobic exercise trainings for 48 weeks. The training will be planned by exercise physiologists, and performed in a progressive manner.

Combination Product: Systematic exercise training

Educational program

ACTIVE COMPARATOR

Educational program on physical activity and health, consisting of four educational sessions in the intervention period.

Behavioral: Educational program

Standard treatment alone

NO INTERVENTION

Data from The Danish MS Registry will serve as control-data for standard treatment alone.

Interventions

Systematic exercise training COMBINATION_PRODUCT

Combination of standard medical treatment and systematic early exercise training in persons with MS.

Systematic exercise training

Educational program BEHAVIORAL

Informations regarding health benefits of physical activity and exercise.

Educational program

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Signed consent
• Definite diagnosis with Relapsing remitting multiple sclerosis (RRMS)
• No more than 2 years since diagnosis
• Expectedly able to carry out high intensity aerobic training
• Able to transport themselves to and from training sessions

You may not qualify if:

• Pregnancy
• Dementia, alcohol abuse, or pacemaker
• Metallic implants, hindering MRI-scans
• Comorbidities hindering participation in high intensity aerobic training

Sponsors & Collaborators

• University of Aarhus: lead
• University of Southern Denmark: collaborator
• Region of Southern Denmark: collaborator

Study Sites (1)

Section for Sport Science, Department of Public Health, University of Aarhus

Aarhus, 8000, Denmark

Location

Related Publications (10)

• Compston A, Coles A. Multiple sclerosis. Lancet. 2008 Oct 25;372(9648):1502-17. doi: 10.1016/S0140-6736(08)61620-7.

  PMID: 18970977 BACKGROUND

• Ziemssen T, De Stefano N, Sormani MP, Van Wijmeersch B, Wiendl H, Kieseier BC. Optimizing therapy early in multiple sclerosis: An evidence-based view. Mult Scler Relat Disord. 2015 Sep;4(5):460-469. doi: 10.1016/j.msard.2015.07.007. Epub 2015 Jul 17.

  PMID: 26346796 BACKGROUND

• Patwardhan MB, Matchar DB, Samsa GP, McCrory DC, Williams RG, Li TT. Cost of multiple sclerosis by level of disability: a review of literature. Mult Scler. 2005 Apr;11(2):232-9. doi: 10.1191/1352458505ms1137oa.

  PMID: 15794399 BACKGROUND

• Wingerchuk DM, Carter JL. Multiple sclerosis: current and emerging disease-modifying therapies and treatment strategies. Mayo Clin Proc. 2014 Feb;89(2):225-40. doi: 10.1016/j.mayocp.2013.11.002.

  PMID: 24485135 BACKGROUND

• Elovaara I. Early treatment in multiple sclerosis. J Neurol Sci. 2011 Dec;311 Suppl 1:S24-8. doi: 10.1016/S0022-510X(11)70005-3.

  PMID: 22206762 BACKGROUND

• Dalgas U, Stenager E, Ingemann-Hansen T. Multiple sclerosis and physical exercise: recommendations for the application of resistance-, endurance- and combined training. Mult Scler. 2008 Jan;14(1):35-53. doi: 10.1177/1352458507079445. Epub 2007 Sep 19.

  PMID: 17881393 BACKGROUND

• Kjolhede T, Siemonsen S, Wenzel D, Stellmann JP, Ringgaard S, Pedersen BG, Stenager E, Petersen T, Vissing K, Heesen C, Dalgas U. Can resistance training impact MRI outcomes in relapsing-remitting multiple sclerosis? Mult Scler. 2018 Sep;24(10):1356-1365. doi: 10.1177/1352458517722645. Epub 2017 Jul 28.

  PMID: 28752800 BACKGROUND

• 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: 40966534 DERIVED

• Riemenschneider M, Hvid LG, Petersen T, Stenager E, Dalgas U. Exercise Therapy in Early Multiple Sclerosis Improves Physical Function But Not Cognition: Secondary Analyses From a Randomized Controlled Trial. Neurorehabil Neural Repair. 2023 May;37(5):288-297. doi: 10.1177/15459683231159659. Epub 2023 Mar 10.

  PMID: 36905131 DERIVED

• Riemenschneider M, Hvid LG, Ringgaard S, Nygaard MKE, Eskildsen SF, Petersen T, Stenager E, Dalgas U. Study protocol: randomised controlled trial evaluating exercise therapy as a supplemental treatment strategy in early multiple sclerosis: the Early Multiple Sclerosis Exercise Study (EMSES). BMJ Open. 2021 Jan 12;11(1):e043699. doi: 10.1136/bmjopen-2020-043699.

  PMID: 33436475 DERIVED

MeSH Terms

Conditions

Multiple Sclerosis; Motor Activity

Condition Hierarchy (Ancestors)

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

Study Officials

• Morten Riemenschneider, MSc

  Section for Sport Science, Department of Public Health, Aarhus University

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: October 16, 2017
• First Posted: October 26, 2017
• Study Start: April 1, 2018
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2021
• Last Updated: November 3, 2022

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will share
• Time Frame: The data will become available after completion of the project, expectedly January 2021. The Danish National Archives stores data without a time frame (forever).
• Access Criteria: Sharing of data can happen upon request to The Danish National Archives.

Locations

DK (1)