Multiple SclerosisNCT04913012
Exercise Booster Sessions in People With Multiple Sclerosis
A study testing Systematic aerobic training, Systematic resistance training and Aerobic training booster sessions in people with Multiple Sclerosis, run by University of Aarhus at 1 site in Denmark.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- Systematic aerobic training, Systematic resistance training and Aerobic training booster sessions
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Aug 2021to 4 Oct 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Comprise comorbidities (cardiovascular-, respiratory-, orthopedic- or other neurological diseases.)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Sustainability of Exercise Therapy by the Use of Exercise Booster Sessions in People With Multiple Sclerosis.
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.
Read the 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
- Conditions
- Multiple Sclerosis
- Being tested
- Systematic aerobic training, Systematic resistance training, Aerobic training booster sessions, Resistance training booster sessions
- Keywords
- Exercise, Rehabilitation
- Medical subject headings
- Multiple Sclerosis, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Systematic aerobic trainingCombination 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.
Systematic resistance trainingCombination 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.
Aerobic training booster sessionsCombination product
Supervised aerobic training booster sessions delivered in the follow up period (two sessions every fifth week).
Resistance training booster sessionsCombination product
Supervised resistance training booster sessions in the follow up period (two sessions every fifth week).
| Study group | Role | What they receive |
|---|---|---|
| Aerobic training booster group | Experimental | Will receive 12 weeks of aerobic training followed by booster sessions + standard care in the 40 follow up period Receives: 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 Receives: 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 Receives: 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 Receives: Combination Product: Systematic resistance training |
| Control group | No intervention | Will receive standard care throughout the study |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline,12 weeks and 52 weeks.
Secondary outcomes (2)
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.
Measured: Baseline, 12 weeks and 52 weeks.
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)
Measured: Baseline, 12 weeks and 52 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2021
- Study start1 Aug 2021
- Primary completion4 Oct 2024
- Study completion4 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Collaborators
- Oxford Brookes University
- Responsible party
- Sponsor
- Investigators
- Laurits Taul-Madsen, MSc., Principal investigator, University of Aarhus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04913012
- Sponsor's protocol ID
- Laurits_Madsen_PhD
- Status last verified
- Dec 2024
- First submitted
- 26 May 2021
- Last updated
- 27 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All data will be stored in The Danish National Archives after completion of the project, and data can be accessed through request to The Danish National Archives.
Publications
Compston A, Coles A. Multiple sclerosis. Lancet. 2008 Oct 25;372(9648):1502-17. doi: 10.1016/S0140-6736(08)61620-7.
PubMed 18970977Calabresi PA. Diagnosis and management of multiple sclerosis. Am Fam Physician. 2004 Nov 15;70(10):1935-44.
PubMed 15571060Pilutti 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.
PubMed 24880538Latimer-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.
PubMed 23669008Pedersen 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.
PubMed 26606383Heesen 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.
PubMed 28607693Dalgas 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.
PubMed 19884575Collett 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.
PubMed 21247971Kjolhede 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.
PubMed 25257612Taul-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.
PubMed 39891566Taul-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.
PubMed 39153792
Study at a glance
From the registry record, last updated by the sponsor on 27 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sustainability of Exercise Therapy by the Use of Exercise Booster Sessions in People With Multiple Sclerosis.
- ClinicalTrials.gov ID
- NCT04913012
- Acronym / sponsor ID
- Laurits_Madsen_PhD
- Conditions
- Multiple Sclerosis
- Keywords
- Exercise, Rehabilitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Collaborators
- Oxford Brookes University
- Study start
- 1 Aug 2021 (actual)
- Primary completion
- 4 Oct 2024 (actual)
- Study completion
- 4 Oct 2024 (actual)
- First posted
- 3 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Aerobic training booster group | Experimental | Combination Product: Systematic aerobic training, Combination Product: Aerobic training booster sessionsWill receive 12 weeks of aerobic training followed by booster sessions + standard care in the 40 follow up period |
| Aerobic training control group | Active comparator | Combination Product: Systematic aerobic trainingWill receive 12 weeks of aerobic training followed by standard care in the 40 follow up period |
| Resistance training booster group | Experimental | Combination Product: Systematic resistance training, Combination Product: Resistance training booster sessionsWill receive 12 weeks of resistance training training followed by booster sessions + standard care in the 40 follow up period |
| Resistance training control group | Active comparator | Combination Product: Systematic resistance trainingWill receive 12 weeks of resistance training followed by standard care in the 40 follow up period |
| Control group | No intervention | –Will receive standard care throughout the study |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (1 listed)
- Comprise comorbidities (cardiovascular-, respiratory-, orthopedic- or other neurological diseases.)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Systematic aerobic trainingTwo-three weekly supervised aerobic exercise sessions for 12 weeks. The training will be planned by exercise physiologists, and performed in a progressive manner. | Combination product | Aerobic training booster group, Aerobic training control group |
| Systematic resistance trainingTwo-three weekly supervised resistance exercise sessions for 12 weeks. The training will be planned by exercise physiologists, and performed in a progressive manner. | Combination product | Resistance training booster group, Resistance training control group |
| Aerobic training booster sessionsSupervised aerobic training booster sessions delivered in the follow up period (two sessions every fifth week). | Combination product | Aerobic training booster group |
| Resistance training booster sessionsSupervised resistance training booster sessions in the follow up period (two sessions every fifth week). | Combination product | Resistance training booster group |
Primary outcome
Change in functional capacity measured as a composite score of the six minute walk test and the 5x sit to stand test (5STS).
Time frame: Baseline,12 weeks and 52 weeks.
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.
2 secondary outcomes
Change in functional capacity measured by the Six spot step test (SSST)
Time frame: Baseline, 12 weeks and 52 weeks.
Change in functional capacity measured by the Multiple Sclerosis Functional Composite (MSFC)
Time frame: Baseline, 12 weeks and 52 weeks.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Dec 2024.
- Background: PubMed 18970977Compston A, Coles A. Multiple sclerosis. Lancet. 2008 Oct 25;372(9648):1502-17. doi: 10.1016/S0140-6736(08)61620-7.
- Background: PubMed 15571060Calabresi PA. Diagnosis and management of multiple sclerosis. Am Fam Physician. 2004 Nov 15;70(10):1935-44.
- Results publication: PubMed 24880538Pilutti 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.
- Results publication: PubMed 23669008Latimer-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.
- Results publication: PubMed 26606383Pedersen 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.
- Results publication: PubMed 28607693Heesen 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.
- Results publication: PubMed 19884575Dalgas 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.
- Results publication: PubMed 21247971Collett 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.
- Results publication: PubMed 25257612Kjolhede 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.
- Derived from this study: PubMed 39891566Taul-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.
- Derived from this study: PubMed 39153792Taul-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.
- Individual participant dataSharing planned: Yes. All data will be stored in The Danish National Archives after completion of the project, and data can be accessed through request to The Danish National Archives.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Laurits Taul-Madsen, MSc. principal investigator
University of Aarhus
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Systematic aerobic training, Systematic resistance training and Aerobic training booster sessions in people with Multiple Sclerosis, run by University of Aarhus at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in functional capacity measured as a composite score of the six minute walk test and the 5x sit to stand test (5STS). (time frame: Baseline,12 weeks and 52 weeks.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04913012, which also lists 11 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Dec 2024.