Clinical trial NCT04913012: Exercise Booster Sessions in People With Multiple Sclerosis
Official title: Sustainability of Exercise Therapy by the Use of Exercise Booster Sessions in People With Multiple Sclerosis.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Multiple Sclerosis
Keywords: Exercise
Rehabilitation
Lead sponsor: University of Aarhus
Sponsor class: OTHER
Collaborators: name: Oxford Brookes University
First posted: 2021-06-03
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: MS is a chronic, autoimmune, and inflammatory disease of the central nervous system, exemplified through marked demyelination and axonal loss. As a result, symptoms such as fatigue, numbness, weakness, depression, walking difficulties and spasticity frequently appear.

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

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

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

Primary outcomes:
measure: Change in functional capacity measured as a composite score of the six minute walk test and the 5x sit to stand test (5STS).
timeFrame: Baseline,12 weeks and 52 weeks.
Secondary outcomes:
measure: Change in functional capacity measured by the Six spot step test (SSST)
timeFrame: Baseline, 12 weeks and 52 weeks.
measure: Change in functional capacity measured by the Multiple Sclerosis Functional Composite (MSFC)
timeFrame: Baseline, 12 weeks and 52 weeks.
Other outcomes:
measure: Change in physical activity, accelerometry
timeFrame: Baseline, 12 weeks and 52 weeks.
measure: Change in aerobic capacity
timeFrame: Baseline, 12 weeks and 52 weeks.
measure: Change in Multiple Sclerosis Walking Scale 12 (MSWS-12)
timeFrame: Baseline, 12 weeks and 52 weeks.
measure: Change in Modified Fatigue Impact Scale (MFIS)
timeFrame: Baseline, 12 weeks and 52 weeks.
measure: Change in Short Form Health Survey 36 (SF-36)
timeFrame: Baseline, 12 weeks and 52 weeks.
measure: Change in Hospital anxiety and depression scale (HADS)
timeFrame: Baseline, 12 weeks and 52 weeks.
measure: Change in self reported physical activity measured by the Baecke questionnaire.
timeFrame: Baseline, 12 weeks and 52 weeks.
measure: Change in maximal strength
timeFrame: Baseline, 12 weeks and 52 weeks.
measure: Change in functional capacity measured by the Timed Up and Go
timeFrame: Baseline, 12 weeks and 52 weeks
measure: Change in cognition measured by the SDMT
timeFrame: Baseline, 12 weeks and 52 weeks.
measure: Change in EQ-5D-5L
timeFrame: Baseline, 12 weeks and 52 weeks
measure: Change in societal costs measured by the HUQ
timeFrame: Baseline, 12 weeks and 52 weeks.
measure: Change in societal costs measured by the IPCQ.
timeFrame: Baseline, 12 weeks and 52 weeks.
measure: Change in falls and fear of falling by the Falls Efficacy Scale
timeFrame: Baseline, 12 weeks and 52 weeks.
Locations:
city: Aarhus
country: Denmark
facility: Aarhus University
Study officials:
affiliation: University of Aarhus
name: Laurits Taul-Madsen, MSc.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Compston A, Coles A. Multiple sclerosis. Lancet. 2008 Oct 25;372(9648):1502-17. doi: 10.1016/S0140-6736(08)61620-7.
citation: Calabresi PA. Diagnosis and management of multiple sclerosis. Am Fam Physician. 2004 Nov 15;70(10):1935-44.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.