Multiple SclerosisPOTOMSNCT04762342

Power Training in Older Multiple Sclerosis Patients

A study testing Power training in people with Multiple Sclerosis and Sclerosis, run by University of Aarhus at 1 site in Denmark.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record

Search all trials

Trial summary

The study seeks to investigate whether 24 weeks of power training has neuroprotective effects in older PwMS. Additional purposes are to examine the effects of 24 weeks power training on physical function, cognitive function and neuromuscular function. Read more about this study

Who is it for?: Ages 60 years and olderHealthy volunteers can take part
Conditions the study is for: Multiple Sclerosis, Sclerosis, Demyelinating Autoimmune Diseases, CNS
What is being tested?: Power training
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 60 participants
Where: 1 siteDenmark
Study dates: 7 Dec 2020to 28 Aug 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 60 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

≥ 60 years of age.
Clinically diagnosed with MS according to the McDonald criteria (48).
Having an EDSS ≤ 6.5.
able to transport themselves to the testing at Aarhus University and Aarhus University Hospital.
able to transport themselves to training, if randomized to the PRP group.

Who cannot join

having comorbidities (cardiovascular, respiratory, orthopedic, or other neurological diseases than MS) affecting PRP participation or MRI scans.
having a pacemaker.
having metallic implant(s) that prevents MRI scans.
having untreated osteoporosis; t-score below -2.5 and a history of low energy facture or t-score below -3.0.
participating in more than two sessions per week of structured PRE and have done so for the past 3 months.
Are cognitively impaired at a level expected to prevent the participant from understanding training and testing instructions.

Trial locations and contacts

1 site in 1 country.

Tobias Gaemelke, MSc contact

+45 28264508

gaemelke@ph.au.dk

Denmark1 site, 1 recruiting

Tobias Gæmelke
Aarhus C, 8000
Tobias K. Gaemelke, Msc, +45 28264508, gaemelke@ph.au.dk
Recruiting

Other trials in Denmark

About this study

Read the detailed description

Over the past 3-4 decades, the lifespan among people with multiple sclerosis (MS) has increased substantially. Today more than one-third of all people with MS are 60 years or older. With advanced age, people with MS are more likely to have impairments in cognitive and physical function.

Positive adaptations within the nervous system (~neuroplasticity) have been shown to occur in people with MS following periods of resistance training (RT). This resembles the observations in young and old healthy individuals. Moreover, a specific type of RT termed power training appears to be particularly beneficial, as it emphasizes an explosive concentric phase of muscle contraction. This taxes the nervous system to a very high extent. As a result, power training has been shown to improve several aspects that rely on the nervous system in older individuals without MS. These aspects include cognition, neuromuscular function, and physical function.

The investigators speculate that older people with MS would also benefit. However, no studies have looked into the effects of power training in older people with MS.

Conditions: Multiple Sclerosis, Sclerosis, Demyelinating Autoimmune Diseases, CNS, Autoimmune Diseases of the Nervous System, Demyelinating Diseases, Healthy Aging
Being tested: Power training
Keywords: Multiple Sclerosis, Healthy aging, Exercise, Neuroprotection
Medical subject headings: Multiple Sclerosis, Sclerosis, Demyelinating Autoimmune Diseases, CNS, Autoimmune Diseases of the Nervous System, Demyelinating Diseases, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Power trainingOther
First a brief warm up on a stationary bike and uni-lateral knee raises is completed.
Power training: Involves exercises performed with fast/explosive muscle contraction during the concentric phase, and slow/controlled (approximately 2-3 s) muscle contraction during the eccentric phase.
Functional- and balance exercises are included from week 9-24.
Progression:
Week 1-4: 3 sets of 12 repetitions at a load of 14 repetitions maximum (RM) with focus on introducing resistance exercise and familiarizing participants with exercises.
Week 5-8: 3 sets of 12 repetitions at a load of 14 RM the power training component.
Week 9-16: 3 sets of 10 repetitions at a load of 12 RM. Week 17-24: 3 sets of 8 repetitions at a load of 10 RM
Strengthening exercises:
- Bilateral leg-press
- Bilateral plantar flexion
- Bilateral knee extension
- Unilateral banded dorsal flexion
- Bilateral lying leg curl
- Back extension
- Shoulder press
- Seated row
- Chest press
- Lat pull-down

Study groups in NCT04762342
Study group	Role	What they receive
Training Group Multiple Sclerosis	Experimental	24 weeks of moderate to high-intensity power training (resistance training- emphasizing an explosive concentric phase of muscle contraction) performed twice weekly. Balance- and functional exercises are included after week 8. Receives: Other: Power training
Control Group Multiple Sclerosis	No intervention	Habitual lifestyle including standard care.

What is being measured

The primary outcome is the main question the study is designed to answer.

Percentage brain volume change.
Whole brain atrophy will be measured from MRI-scans.
Measured: Baseline, after 24 weeks and after 48 weeks.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

7 Dec 202028 Aug 2024

First posted21 Feb 2021
Study start7 Dec 2020
Primary completion28 Aug 2024 (estimated)
Study completion28 Aug 2024 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (14)Papers the sponsor has linked to this study.
Other trials for Multiple SclerosisStudies of the same condition, open and under way.
More trials run by University of AarhusThe sponsor's other registered studies.
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: Single blind
Who is masked: Outcomes assessor
Enrolment: 60 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04762342
Sponsor's protocol ID: 4168624
Acronym: POTOMS
Status last verified: Mar 2023
First submitted: 5 Feb 2021
Last updated: 23 Jun 2023
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Hurwitz BJ. Analysis of current multiple sclerosis registries. Neurology. 2011 Jan 4;76(1 Suppl 1):S7-13. doi: 10.1212/WNL.0b013e31820502f6.
PubMed 21205683
Marrie R, Horwitz R, Cutter G, Tyry T, Campagnolo D, Vollmer T. Comorbidity, socioeconomic status and multiple sclerosis. Mult Scler. 2008 Sep;14(8):1091-8. doi: 10.1177/1352458508092263.
PubMed 18728060
Hvid LG, Strotmeyer ES, Skjodt M, Magnussen LV, Andersen M, Caserotti P. Voluntary muscle activation improves with power training and is associated with changes in gait speed in mobility-limited older adults - A randomized controlled trial. Exp Gerontol. 2016 Jul;80:51-6. doi: 10.1016/j.exger.2016.03.018. Epub 2016 Apr 14.
PubMed 27090485
Aagaard P, Suetta C, Caserotti P, Magnusson SP, Kjaer M. Role of the nervous system in sarcopenia and muscle atrophy with aging: strength training as a countermeasure. Scand J Med Sci Sports. 2010 Feb;20(1):49-64. doi: 10.1111/j.1600-0838.2009.01084.x.
PubMed 20487503
Schoenfeld BJ, Contreras B, Willardson JM, Fontana F, Tiryaki-Sonmez G. Muscle activation during low- versus high-load resistance training in well-trained men. Eur J Appl Physiol. 2014 Dec;114(12):2491-7. doi: 10.1007/s00421-014-2976-9. Epub 2014 Aug 12.
PubMed 25113097
Best JR, Chiu BK, Liang Hsu C, Nagamatsu LS, Liu-Ambrose T. Long-Term Effects of Resistance Exercise Training on Cognition and Brain Volume in Older Women: Results from a Randomized Controlled Trial. J Int Neuropsychol Soc. 2015 Nov;21(10):745-56. doi: 10.1017/S1355617715000673.
PubMed 26581787
Liu-Ambrose T, Nagamatsu LS, Graf P, Beattie BL, Ashe MC, Handy TC. Resistance training and executive functions: a 12-month randomized controlled trial. Arch Intern Med. 2010 Jan 25;170(2):170-8. doi: 10.1001/archinternmed.2009.494.
PubMed 20101012
Reid KF, Martin KI, Doros G, Clark DJ, Hau C, Patten C, Phillips EM, Frontera WR, Fielding RA. Comparative effects of light or heavy resistance power training for improving lower extremity power and physical performance in mobility-limited older adults. J Gerontol A Biol Sci Med Sci. 2015 Mar;70(3):374-80. doi: 10.1093/gerona/glu156. Epub 2014 Sep 8.
PubMed 25199912
Caserotti P, Aagaard P, Larsen JB, Puggaard L. Explosive heavy-resistance training in old and very old adults: changes in rapid muscle force, strength and power. Scand J Med Sci Sports. 2008 Dec;18(6):773-82. doi: 10.1111/j.1600-0838.2007.00732.x. Epub 2008 Jan 30.
PubMed 18248533
Bottaro M, Machado SN, Nogueira W, Scales R, Veloso J. Effect of high versus low-velocity resistance training on muscular fitness and functional performance in older men. Eur J Appl Physiol. 2007 Feb;99(3):257-64. doi: 10.1007/s00421-006-0343-1. Epub 2006 Dec 5.
PubMed 17146693
Earles DR, Judge JO, Gunnarsson OT. Velocity training induces power-specific adaptations in highly functioning older adults. Arch Phys Med Rehabil. 2001 Jul;82(7):872-8. doi: 10.1053/apmr.2001.23838.
PubMed 11441371
Henwood TR, Riek S, Taaffe DR. Strength versus muscle power-specific resistance training in community-dwelling older adults. J Gerontol A Biol Sci Med Sci. 2008 Jan;63(1):83-91. doi: 10.1093/gerona/63.1.83.
PubMed 18245765
Kupjetz M, Langeskov-Christensen M, Riemenschneider M, Inerle S, Ligges U, Gaemelke T, Patt N, Bansi J, Gonzenbach RR, Reuter M, Rosenberger F, Meyer T, McCann A, Ueland PM, Eskildsen SF, Nygaard MKE, Joisten N, Hvid L, Dalgas U, Zimmer P. Persons With Multiple Sclerosis Reveal Distinct Kynurenine Pathway Metabolite Patterns: A Multinational Cross-Sectional Study. Neurol Neuroimmunol Neuroinflamm. 2025 Nov;12(6):e200461. doi: 10.1212/NXI.0000000000200461. Epub 2025 Sep 18.
PubMed 40966534
Gaemelke T, Laustsen C, Feys P, Folkestad L, Andersen MS, Jorgensen NR, Jorgensen ML, Jespersen SN, Ringgaard S, Eskildsen SF, Dalgas U, Hvid LG. Effects of power training in older patients with multiple sclerosis on neurodegeneration, neuromuscular function, and physical function. A study protocol for the "power training in older multiple sclerosis patients (PoTOMS) randomized control trial. Contemp Clin Trials Commun. 2024 Feb 19;38:101279. doi: 10.1016/j.conctc.2024.101279. eCollection 2024 Apr.
PubMed 38444875

Want to know more?

Tobias Gaemelke, MSc

+45 28264508

gaemelke@ph.au.dk

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 23 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Power Training in Older Multiple Sclerosis Patients
ClinicalTrials.gov ID: NCT04762342
Acronym / sponsor ID: POTOMS / 4168624
Conditions: Multiple Sclerosis, Sclerosis, Demyelinating Autoimmune Diseases, CNS, Autoimmune Diseases of the Nervous System, Demyelinating Diseases, Healthy Aging
Keywords: Multiple Sclerosis, Healthy aging, Exercise, Neuroprotection
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 60 participants (estimated)
Lead sponsor: University of AarhusUniversity, hospital or other
Collaborators: University of Southern Denmark, University of Copenhagen
Study start: 7 Dec 2020 (actual)
Primary completion: 28 Aug 2024 (estimated)
Study completion: 28 Aug 2024 (estimated)
First posted: 21 Feb 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.

Detailed description

The investigators speculate that older people with MS would also benefit. However, no studies have looked into the effects of power training in older people with MS.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Training Group Multiple Sclerosis	Experimental	Other: Power training24 weeks of moderate to high-intensity power training (resistance training- emphasizing an explosive concentric phase of muscle contraction) performed twice weekly. Balance- and functional exercises are included after week 8.
Control Group Multiple Sclerosis	No intervention	–Habitual lifestyle including standard care.

Who may qualify

Ages: 60 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

≥ 60 years of age.
Clinically diagnosed with MS according to the McDonald criteria (48).
Having an EDSS ≤ 6.5.
able to transport themselves to the testing at Aarhus University and Aarhus University Hospital.
able to transport themselves to training, if randomized to the PRP group.

Key exclusion criteria (6 listed)

having comorbidities (cardiovascular, respiratory, orthopedic, or other neurological diseases than MS) affecting PRP participation or MRI scans.
having a pacemaker.
having metallic implant(s) that prevents MRI scans.
having untreated osteoporosis; t-score below -2.5 and a history of low energy facture or t-score below -3.0.
participating in more than two sessions per week of structured PRE and have done so for the past 3 months.

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
Power trainingFirst a brief warm up on a stationary bike and uni-lateral knee raises is completed. Power training: Involves exercises performed with fast/explosive muscle contraction during the concentric phase, and slow/controlled (approximately 2-3 s) muscle contraction during the eccentric phase. Functional- and balance exercises are included from week 9-24. Progression: Week 1-4: 3 sets of 12 repetitions at a load of 14 repetitions maximum (RM) with focus on introducing resistance exercise and familiarizing participants with exercises. Week 5-8: 3 sets of 12 repetitions at a load of 14 RM the power training component. Week 9-16: 3 sets of 10 repetitions at a load of 12 RM. Week 17-24: 3 sets of 8 repetitions at a load of 10 RM Strengthening exercises: * Bilateral leg-press * Bilateral plantar flexion * Bilateral knee extension * Unilateral banded dorsal flexion * Bilateral lying leg curl * Back extension * Shoulder press * Seated row * Chest press * Lat pull-down	Other	Training Group Multiple Sclerosis

Primary outcome

Percentage brain volume change.
Time frame: Baseline, after 24 weeks and after 48 weeks.
Whole brain atrophy will be measured from MRI-scans.

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2023.
Background: PubMed 21205683Hurwitz BJ. Analysis of current multiple sclerosis registries. Neurology. 2011 Jan 4;76(1 Suppl 1):S7-13. doi: 10.1212/WNL.0b013e31820502f6.
Background: PubMed 18728060Marrie R, Horwitz R, Cutter G, Tyry T, Campagnolo D, Vollmer T. Comorbidity, socioeconomic status and multiple sclerosis. Mult Scler. 2008 Sep;14(8):1091-8. doi: 10.1177/1352458508092263.
Background: PubMed 27090485Hvid LG, Strotmeyer ES, Skjodt M, Magnussen LV, Andersen M, Caserotti P. Voluntary muscle activation improves with power training and is associated with changes in gait speed in mobility-limited older adults - A randomized controlled trial. Exp Gerontol. 2016 Jul;80:51-6. doi: 10.1016/j.exger.2016.03.018. Epub 2016 Apr 14.
Background: PubMed 20487503Aagaard P, Suetta C, Caserotti P, Magnusson SP, Kjaer M. Role of the nervous system in sarcopenia and muscle atrophy with aging: strength training as a countermeasure. Scand J Med Sci Sports. 2010 Feb;20(1):49-64. doi: 10.1111/j.1600-0838.2009.01084.x.
Background: PubMed 25113097Schoenfeld BJ, Contreras B, Willardson JM, Fontana F, Tiryaki-Sonmez G. Muscle activation during low- versus high-load resistance training in well-trained men. Eur J Appl Physiol. 2014 Dec;114(12):2491-7. doi: 10.1007/s00421-014-2976-9. Epub 2014 Aug 12.
Background: PubMed 26581787Best JR, Chiu BK, Liang Hsu C, Nagamatsu LS, Liu-Ambrose T. Long-Term Effects of Resistance Exercise Training on Cognition and Brain Volume in Older Women: Results from a Randomized Controlled Trial. J Int Neuropsychol Soc. 2015 Nov;21(10):745-56. doi: 10.1017/S1355617715000673.
Background: PubMed 20101012Liu-Ambrose T, Nagamatsu LS, Graf P, Beattie BL, Ashe MC, Handy TC. Resistance training and executive functions: a 12-month randomized controlled trial. Arch Intern Med. 2010 Jan 25;170(2):170-8. doi: 10.1001/archinternmed.2009.494.
Background: PubMed 25199912Reid KF, Martin KI, Doros G, Clark DJ, Hau C, Patten C, Phillips EM, Frontera WR, Fielding RA. Comparative effects of light or heavy resistance power training for improving lower extremity power and physical performance in mobility-limited older adults. J Gerontol A Biol Sci Med Sci. 2015 Mar;70(3):374-80. doi: 10.1093/gerona/glu156. Epub 2014 Sep 8.
Background: PubMed 18248533Caserotti P, Aagaard P, Larsen JB, Puggaard L. Explosive heavy-resistance training in old and very old adults: changes in rapid muscle force, strength and power. Scand J Med Sci Sports. 2008 Dec;18(6):773-82. doi: 10.1111/j.1600-0838.2007.00732.x. Epub 2008 Jan 30.
Background: PubMed 17146693Bottaro M, Machado SN, Nogueira W, Scales R, Veloso J. Effect of high versus low-velocity resistance training on muscular fitness and functional performance in older men. Eur J Appl Physiol. 2007 Feb;99(3):257-64. doi: 10.1007/s00421-006-0343-1. Epub 2006 Dec 5.
Background: PubMed 11441371Earles DR, Judge JO, Gunnarsson OT. Velocity training induces power-specific adaptations in highly functioning older adults. Arch Phys Med Rehabil. 2001 Jul;82(7):872-8. doi: 10.1053/apmr.2001.23838.
Background: PubMed 18245765Henwood TR, Riek S, Taaffe DR. Strength versus muscle power-specific resistance training in community-dwelling older adults. J Gerontol A Biol Sci Med Sci. 2008 Jan;63(1):83-91. doi: 10.1093/gerona/63.1.83.
Individual participant dataSharing planned: No

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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.

Tobias Gaemelke, MSc contact

+45 28264508

gaemelke@ph.au.dk

Tobias Gaemelke, Msc principal investigator

Exercise Biology, Department of Public Health, Aarhus University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Power training in people with Multiple Sclerosis and 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 5 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 23 Jun 2023. 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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Tobias Gaemelke, MSc (+45 28264508, gaemelke@ph.au.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage brain volume change. (time frame: Baseline, after 24 weeks and after 48 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 NCT04762342, which also lists 14 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 23 Jun 2023.