Exercise Booster Sessions in People With Multiple Sclerosis

Multiple Sclerosis Clinical Trial

Official title:

Sustainability of Exercise Therapy by the Use of Exercise Booster Sessions in People With Multiple Sclerosis.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04913012
• Other study ID #: Laurits_Madsen_PhD
• Status: Recruiting
• Phase: N/A
• Start date: August 1, 2021
• Est. completion date: September 2024

Study information

• Verified date: November 2023
• Source: University of Aarhus
• Contact: Laurits Taul-Madsen, MSc.
• Phone: +45 61656063
• Email: ltm[@]ph.au.dk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: September 2024
• Est. primary completion date: September 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.)

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis

Intervention

Combination Product:
• 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).

Locations

Country	Name	City	State
Denmark	Aarhus University	Aarhus

Sponsors (2)

Lead Sponsor	Collaborator
University of Aarhus	Oxford Brookes University

Country where clinical trial is conducted

Denmark, 

References & Publications (9)

Calabresi PA. Diagnosis and management of multiple sclerosis. Am Fam Physician. 2004 Nov 15;70(10):1935-44. — View 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: 10.1177/1 — View Citation

Compston A, Coles A. Multiple sclerosis. Lancet. 2008 Oct 25;372(9648):1502-17. doi: 10.1016/S0140-6736(08)61620-7. — View 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.0b013e31 — View 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 multi — View 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 main — View 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 — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in physical activity, accelerometry	Measurement of level of physical activity by wearing a accelerometer for 7 days at each time point. Measured in counts/min.	Baseline, 12 weeks and 52 weeks.
Other	Change in aerobic capacity	Maximal oxygen uptake test on bike ergometer, measured by indirect calorimetry.	Baseline, 12 weeks and 52 weeks.
Other	Change in Multiple Sclerosis Walking Scale 12 (MSWS-12)	Questionnaire assessing the impact of the disease on walking. Each question is scored from 1-5 and then summed and transformed to a 0-100 scale. Higher scores indicate a greater impact on walking.	Baseline, 12 weeks and 52 weeks.
Other	Change in Modified Fatigue Impact Scale (MFIS)	Questionnaire assessing the effects of fatigue on physical, cognitive and psychosocial functioning. The score of the MFIS is the sum of the scores for the 21 items. A higher score represents a higher impact of fatigue, in general or in relation to one of the above mentioned areas.	Baseline, 12 weeks and 52 weeks.
Other	Change in Short Form Health Survey 36 (SF-36)	Questionnaire assessing health status. The SF-36 consists of eight subscales, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability.	Baseline, 12 weeks and 52 weeks.
Other	Change in Hospital anxiety and depression scale (HADS)	Questionnaire assessing anxiety and depression. It consists of two subscales (anxiety and depression), and should be scored separately. A higher score indicates a higher degree of anxiety and depression.	Baseline, 12 weeks and 52 weeks.
Other	Change in self reported physical activity measured by the Baecke questionnaire.	Questionnaire assessing the self reported amount of physical activity. This questionnaire quantifies the habitual physical activity level in three indexes: occupational (at work), sport (structured exercise) and leisure (leisure time). Each index is scored from 1 to 5, with 5 indicating the highest level of physical activity	Baseline, 12 weeks and 52 weeks.
Other	Change in maximal strength	Maximal strength measurement measured in the knee extensors by isokinetic dynamometry.	Baseline, 12 weeks and 52 weeks.
Primary	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	Change in functional capacity measured by the Six spot step test (SSST)	SSST is a measure of walking ability, balance and coordination. Measured as the time to complete the six-spot course.	Baseline, 12 weeks and 52 weeks.
Secondary	Change in functional capacity measured by the Multiple Sclerosis Functional Composite (MSFC)	Composite score from Timed 25-Feet Walk Test (T25FWT), 9-Hole Peg Test (9HPT), Paced Auditory Serial Addition Test (PASAT)	Baseline, 12 weeks and 52 weeks.