Exercise Booster Sessions in People With Multiple Sclerosis
NCT ID: NCT04913012
Last Updated: 2024-12-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
150 participants
INTERVENTIONAL
2021-08-01
2024-10-04
Brief Summary
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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.
Detailed Description
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Although there is no cure for MS, several disease-modifying therapies are available. These can potentially slow the progression of disabilities and reduce the overall disease burden. This is of great interest from both an individual perspective, where increased disability is associated with a lowered health-related quality of life, and from a societal perspective, where increased disability is associated with larger costs.
Over the past decades exercise has been shown to be safe, tolerable and beneficial in persons with MS (PwMS). Hence, it is known to be an effective way of treating symptoms such as fatigue7, muscle weakness, walking impairments and depression. As with other chronic diseases, exercise for PwMS has been proposed as "medicine". However, in order to benefit from the positive effects of any kind of treatment (i.e. most medical drugs or exercise) one has to adhere to the prescriptions of the treatment (i.e. dose and timing). Despite all the potential benefits of exercise therapy for PwMS, one of the major challenges relate to long-term maintenance of exercise efforts.
An emerging concept that may hold the potential to increase the sustainability of exercise therapy is supervised "exercise booster sessions" (i.e. training sessions provided regularly throughout the follow-up period, to sustain effects of the preceding exercise intervention). These can be placed regularly during the follow-up period, where patients attend a number of supervised high-intensity exercise sessions, hereby trying to boost the effects of the preceding exercise intervention. Furthermore, exercise booster sessions can potentially motivate the patient to keep exercising throughout the follow up period.
However, the optimal way of utilizing this concept is still not fully understood, and has not yet been tried in neurological patients.
Therefore, the main purpose of the present study is to investigate how exercise booster sessions combined with usual care performed over a period of 40 weeks affects the sustainability of effects on functional capacity induced by a 12-week exercise intervention.
It is hypothesized that participants receiving exercise booster sessions + usual care during follow up will have a better functional capacity at follow up, than the participants receiving usual care only.
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.
The 12 week exercise intervention will consist of 2-3 weekly supervised exercise sessions. The training will be planned by exercise physiologists and performed in a progressive manner. To allow handling of a large number of participants, who is also geographically spread, the exercise intervention will be locally anchored, but at the same time supervised by student employees and controlled by internet- and telephonic communication.
Participants allocated to exercise booster sessions will receive two sessions every fifth week during the follow up period.
The power calculation is based on the primary purpose of the study which is to investigate the effect of frequently applied exercise booster sessions. To set the estimated number of participants, a two-sample two-sided power calculation has been conducted. Based on previous studies, a mean difference on functional capacity between the group receiving usual care and the group receiving exercise booster sessions + usual care, regardless of exercise intervention, is expected to be 6% with a standard deviation (SD) of ±10%.
The level of significance was set as 5% and a statistical power of 80%. According to the power calculation each group shall contain 60 participants (expected drop-out rate of 30 % is included).
The results of these studies can have great clinical implications in many ways. If we find that by adding exercise booster sessions in a follow up period, one can maintain, or maybe even improve, functional capacity over a long period, this would be a novel finding making ground for new rehabilitation opportunities
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Aerobic training booster group
Will receive 12 weeks of aerobic training followed by booster sessions + standard care in the 40 follow up period
Systematic aerobic training
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 sessions
Supervised aerobic training booster sessions delivered in the follow up period (two sessions every fifth week).
Aerobic training control group
Will receive 12 weeks of aerobic training followed by standard care in the 40 follow up period
Systematic aerobic training
Two-three weekly supervised aerobic exercise sessions for 12 weeks. The training will be planned by exercise physiologists, and performed in a progressive manner.
Resistance training booster group
Will receive 12 weeks of resistance training training followed by booster sessions + standard care in the 40 follow up period
Systematic resistance training
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 sessions
Supervised resistance training booster sessions in the follow up period (two sessions every fifth week).
Resistance training control group
Will receive 12 weeks of resistance training followed by standard care in the 40 follow up period
Systematic resistance training
Two-three weekly supervised resistance exercise sessions for 12 weeks. The training will be planned by exercise physiologists, and performed in a progressive manner.
Control group
Will receive standard care throughout the study
No interventions assigned to this group
Interventions
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Systematic aerobic training
Two-three weekly supervised aerobic exercise sessions for 12 weeks. The training will be planned by exercise physiologists, and performed in a progressive manner.
Systematic resistance training
Two-three weekly supervised resistance exercise sessions for 12 weeks. The training will be planned by exercise physiologists, and performed in a progressive manner.
Aerobic training booster sessions
Supervised aerobic training booster sessions delivered in the follow up period (two sessions every fifth week).
Resistance training booster sessions
Supervised resistance training booster sessions in the follow up period (two sessions every fifth week).
Eligibility Criteria
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Inclusion Criteria
* Walking \<650m on 6MWT.
* Exercising ≤ two sessions per week of moderate-to-high intensity during the past six months.
Exclusion Criteria
18 Years
ALL
No
Sponsors
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Oxford Brookes University
OTHER
University of Aarhus
OTHER
Responsible Party
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Principal Investigators
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Laurits Taul-Madsen, MSc.
Role: PRINCIPAL_INVESTIGATOR
University of Aarhus
Locations
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Aarhus University
Aarhus, , Denmark
Countries
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References
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Compston A, Coles A. Multiple sclerosis. Lancet. 2008 Oct 25;372(9648):1502-17. doi: 10.1016/S0140-6736(08)61620-7.
Calabresi PA. Diagnosis and management of multiple sclerosis. Am Fam Physician. 2004 Nov 15;70(10):1935-44.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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Laurits_Madsen_PhD
Identifier Type: -
Identifier Source: org_study_id