Power Training in Older Multiple Sclerosis Patients

NCT04762342 | Unknown DMC

• 1 other identifier: 4168624
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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. Further, it is investigated whether the potential effects of power training are maintained after 24 weeks of follow-up.

Conditions

Multiple Sclerosis; Sclerosis; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Healthy Aging; Aging

Keywords

Multiple Sclerosis; Healthy aging; Exercise; Neuroprotection

Outcome Measures

Primary Outcomes (1)

• Percentage brain volume change.

  Whole brain atrophy will be measured from MRI-scans.

  Baseline, after 24 weeks and after 48 weeks.

Other Outcomes (41)

• Normalized gray and white matter volume change.

  Baseline, after 24 weeks and after 48 weeks.

• Volume of the brain nucleis: thalamus, hippocampus, putamen, caudate, globus pallidus, corticospinal tract, cingulate gyrus, corpus callosum, cervical spinal volume, motor cortex

  Baseline, after 24 weeks and after 48 weeks.

• Diffusivity of the brain nucleis: thalamus, hippocampus, putamen, caudate, globus pallidus, corticospinal tract, cingulate gyrus, corpus callosum, cervical spinal volume, motor cortex

  Baseline, after 24 weeks and after 48 weeks.

Study Arms (2)

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.

Other: Power training

Control Group Multiple Sclerosis

NO INTERVENTION

Habitual lifestyle including standard care.

Interventions

Power training OTHER

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

Training Group Multiple Sclerosis

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥ 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Aarhus: lead
• University of Southern Denmark: collaborator
• University of Copenhagen: collaborator

Study Sites (1)

Tobias Gæmelke

Aarhus C, 8000, Denmark

RECRUITING

Related Publications (14)

• Hurwitz BJ. Analysis of current multiple sclerosis registries. Neurology. 2011 Jan 4;76(1 Suppl 1):S7-13. doi: 10.1212/WNL.0b013e31820502f6.

  PMID: 21205683 BACKGROUND

• 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.

  PMID: 18728060 BACKGROUND

• 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.

  PMID: 27090485 BACKGROUND

• 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.

  PMID: 20487503 BACKGROUND

• 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.

  PMID: 25113097 BACKGROUND

• 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.

  PMID: 26581787 BACKGROUND

• 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.

  PMID: 20101012 BACKGROUND

• 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.

  PMID: 25199912 BACKGROUND

• 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.

  PMID: 18248533 BACKGROUND

• 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.

  PMID: 17146693 BACKGROUND

• 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.

  PMID: 11441371 BACKGROUND

• 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.

  PMID: 18245765 BACKGROUND

• 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.

  PMID: 40966534 DERIVED

• 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.

  PMID: 38444875 DERIVED

MeSH Terms

Conditions

Multiple Sclerosis; Sclerosis; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Motor Activity

Condition Hierarchy (Ancestors)

Nervous System Diseases; Autoimmune Diseases; Immune System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Leukoencephalopathies; Brain Diseases; Central Nervous System Diseases; Behavior

Study Officials

• Tobias Gaemelke, Msc

  Exercise Biology, Department of Public Health, Aarhus University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tobias Gaemelke, MSc

CONTACT

+45 28264508; gaemelke@ph.au.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 5, 2021
• First Posted: February 21, 2021
• Study Start: December 7, 2020
• Primary Completion: August 28, 2024
• Study Completion: August 28, 2024
• Last Updated: June 23, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)