Exercise Booster Sessions in People With Multiple Sclerosis

NCT04913012 | Completed DMC

• 1 other identifier: Laurits_Madsen_PhD
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

This study wants to investigate whether exercise booster sessions applied in the follow-up period after an exercise intervention can increase the sustainability of exercise induced effects in persons with multiple sclerosis. The study will be a randomized, multi-site, controlled trial. Participants will from the beginning be allocated to either aerobic training group, resistance training group or control group. After a 12 week exercise intervention, the exercise groups will be additionally randomized to receive either exercise booster sessions + standard care or just standard care in the 40 week follow up period. It is hypothesized that exercise booster sessions can increase the sustainability of exercise induced effects.

Conditions

Multiple Sclerosis

Keywords

Exercise; Rehabilitation

Outcome Measures

Primary Outcomes (1)

• Change in functional capacity measured as a composite score of the six minute walk test and the 5x sit to stand test (5STS).

  The six minute walk test it the distance covered during a six-minute maximal walking test. The 5STS is the time used to stand up from a chair and sit again five times.

  Baseline,12 weeks and 52 weeks.

Secondary Outcomes (2)

• Change in functional capacity measured by the Six spot step test (SSST)

  Baseline, 12 weeks and 52 weeks.

• Change in functional capacity measured by the Multiple Sclerosis Functional Composite (MSFC)

  Baseline, 12 weeks and 52 weeks.

Other Outcomes (14)

• Change in physical activity, accelerometry

  Baseline, 12 weeks and 52 weeks.

• Change in aerobic capacity

  Baseline, 12 weeks and 52 weeks.

• Change in Multiple Sclerosis Walking Scale 12 (MSWS-12)

  Baseline, 12 weeks and 52 weeks.

Study Arms (5)

Aerobic training booster group

EXPERIMENTAL

Will receive 12 weeks of aerobic training followed by booster sessions + standard care in the 40 follow up period

Combination Product: Systematic aerobic training; Combination Product: Aerobic training booster sessions

Aerobic training control group

ACTIVE COMPARATOR

Will receive 12 weeks of aerobic training followed by standard care in the 40 follow up period

Combination Product: Systematic aerobic training

Resistance training booster group

EXPERIMENTAL

Will receive 12 weeks of resistance training training followed by booster sessions + standard care in the 40 follow up period

Combination Product: Systematic resistance training; Combination Product: Resistance training booster sessions

Resistance training control group

ACTIVE COMPARATOR

Will receive 12 weeks of resistance training followed by standard care in the 40 follow up period

Combination Product: Systematic resistance training

Control group

NO INTERVENTION

Will receive standard care throughout the study

Interventions

Systematic aerobic training COMBINATION_PRODUCT

Two-three weekly supervised aerobic exercise sessions for 12 weeks. The training will be planned by exercise physiologists, and performed in a progressive manner.

Aerobic training booster group; Aerobic training control group

Systematic resistance training COMBINATION_PRODUCT

Two-three weekly supervised resistance exercise sessions for 12 weeks. The training will be planned by exercise physiologists, and performed in a progressive manner.

Resistance training booster group; Resistance training control group

Aerobic training booster sessions COMBINATION_PRODUCT

Supervised aerobic training booster sessions delivered in the follow up period (two sessions every fifth week).

Aerobic training booster group

Resistance training booster sessions COMBINATION_PRODUCT

Supervised resistance training booster sessions in the follow up period (two sessions every fifth week).

Resistance training booster group

Eligibility Criteria

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

You may qualify if:

• A definite diagnosis of MS, according to the McDonald criteria
• Walking \<650m on 6MWT.
• Exercising ≤ two sessions per week of moderate-to-high intensity during the past six months.

You may not qualify if:

• Comprise comorbidities (cardiovascular-, respiratory-, orthopedic- or other neurological diseases.)

Sponsors & Collaborators

• University of Aarhus: lead
• Oxford Brookes University: collaborator

Study Sites (1)

Aarhus University

Aarhus, 8000, Denmark

Location

Related Publications (11)

• 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

• Calabresi PA. Diagnosis and management of multiple sclerosis. Am Fam Physician. 2004 Nov 15;70(10):1935-44.

  PMID: 15571060 BACKGROUND

• Pilutti LA, Platta ME, Motl RW, Latimer-Cheung AE. The safety of exercise training in multiple sclerosis: a systematic review. J Neurol Sci. 2014 Aug 15;343(1-2):3-7. doi: 10.1016/j.jns.2014.05.016. Epub 2014 May 15.

  PMID: 24880538 RESULT

• Latimer-Cheung AE, Pilutti LA, Hicks AL, Martin Ginis KA, Fenuta AM, MacKibbon KA, Motl RW. Effects of exercise training on fitness, mobility, fatigue, and health-related quality of life among adults with multiple sclerosis: a systematic review to inform guideline development. Arch Phys Med Rehabil. 2013 Sep;94(9):1800-1828.e3. doi: 10.1016/j.apmr.2013.04.020. Epub 2013 May 10.

  PMID: 23669008 RESULT

• Pedersen BK, Saltin B. Exercise as medicine - evidence for prescribing exercise as therapy in 26 different chronic diseases. Scand J Med Sci Sports. 2015 Dec;25 Suppl 3:1-72. doi: 10.1111/sms.12581.

  PMID: 26606383 RESULT

• Heesen C, Bruce J, Gearing R, Moss-Morris R, Weinmann J, Hamalainen P, Motl R, Dalgas U, Kos D, Visioli F, Feys P, Solari A, Finlayson M, Eliasson L, Matthews V, Bogossian A, Liethmann K, Kopke S, Bissell P. Adherence to behavioural interventions in multiple sclerosis: Follow-up meeting report (AD@MS-2). Mult Scler J Exp Transl Clin. 2015 May 12;1:2055217315585333. doi: 10.1177/2055217315585333. eCollection 2015 Jan-Dec.

  PMID: 28607693 RESULT

• Dalgas U, Stenager E, Jakobsen J, Petersen T, Hansen HJ, Knudsen C, Overgaard K, Ingemann-Hansen T. Resistance training improves muscle strength and functional capacity in multiple sclerosis. Neurology. 2009 Nov 3;73(18):1478-84. doi: 10.1212/WNL.0b013e3181bf98b4.

  PMID: 19884575 RESULT

• Collett J, Dawes H, Meaney A, Sackley C, Barker K, Wade D, Izardi H, Bateman J, Duda J, Buckingham E. Exercise for multiple sclerosis: a single-blind randomized trial comparing three exercise intensities. Mult Scler. 2011 May;17(5):594-603. doi: 10.1177/1352458510391836. Epub 2011 Jan 19.

  PMID: 21247971 RESULT

• Kjolhede T, Vissing K, de Place L, Pedersen BG, Ringgaard S, Stenager E, Petersen T, Dalgas U. Neuromuscular adaptations to long-term progressive resistance training translates to improved functional capacity for people with multiple sclerosis and is maintained at follow-up. Mult Scler. 2015 Apr;21(5):599-611. doi: 10.1177/1352458514549402. Epub 2014 Sep 25.

  PMID: 25257612 RESULT

• Taul-Madsen L, Hvid LG, Riis H, Brolos MK, Lundbye-Jensen J, Dalgas U. A head-to-head comparison of the effects of aerobic versus resistance training on physical capacity and physical function in people with multiple sclerosis: Results from the MSBOOST trial. Mult Scler. 2025 Feb;31(2):174-183. doi: 10.1177/13524585241305496. Epub 2024 Dec 30.

  PMID: 39891566 DERIVED

• Taul-Madsen L, Hvid LG, Sellebjerg F, Christensen JR, Ratzer R, Sejbaek T, Svendsen KB, Papp V, Hojsgaard Chow H, Lundbye-Jensen J, Dawes H, Dalgas U. Study protocol: effects of exercise booster sessions on preservation of exercise-induced adaptations in persons with multiple sclerosis, a multicentre randomised controlled trial-the MS BOOSTER trial. BMJ Open. 2024 Aug 17;14(8):e085241. doi: 10.1136/bmjopen-2024-085241.

  PMID: 39153792 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

• Laurits Taul-Madsen, MSc.

  University of Aarhus

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 26, 2021
• First Posted: June 3, 2021
• Study Start: August 1, 2021
• Primary Completion: October 4, 2024
• Study Completion: October 4, 2024
• Last Updated: December 27, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: The data will become available after completion of the project, expectedly May 2024. 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)