Power Training in Older Multiple Sclerosis Patients

Multiple Sclerosis Clinical Trial

— POTOMS  

Official title:

Power Training in Older Multiple Sclerosis Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04762342
• Other study ID #: 4168624
• Status: Recruiting
• Phase: N/A
• Start date: December 7, 2020
• Est. completion date: August 28, 2024

Study information

• Verified date: March 2023
• Source: University of Aarhus
• Contact: Tobias Gaemelke, MSc
• Phone: +45 28264508
• Email: gaemelke[@]ph.au.dk
• Is FDA regulated: No
• Study type: Interventional

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: August 28, 2024
• Est. primary completion date: August 28, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 60 Years and older

Eligibility

Inclusion Criteria:

• = 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.

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

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

Intervention

Other:
• Power training
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

Locations

Country	Name	City	State
Denmark	Tobias Gæmelke	Aarhus C

Sponsors (3)

Lead Sponsor	Collaborator
University of Aarhus	University of Copenhagen, University of Southern Denmark

Country where clinical trial is conducted

Denmark, 

References & Publications (12)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 12 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Normalized gray and white matter volume change.	MRI scan.	Baseline, after 24 weeks and after 48 weeks.
Other	Volume of the brain nucleis: thalamus, hippocampus, putamen, caudate, globus pallidus, corticospinal tract, cingulate gyrus, corpus callosum, cervical spinal volume, motor cortex	MRI scan.	Baseline, after 24 weeks and after 48 weeks.
Other	Diffusivity of the brain nucleis: thalamus, hippocampus, putamen, caudate, globus pallidus, corticospinal tract, cingulate gyrus, corpus callosum, cervical spinal volume, motor cortex	DTI scan.	Baseline, after 24 weeks and after 48 weeks.
Other	White matter fibre orientations	MKI scan.	Baseline, after 24 weeks and after 48 weeks.
Other	Glial fibrillary acidic protein (GFAP) change.	Resting blood sample- Marker of neurodegeneration.	Baseline, after 24 weeks and after 48 weeks.
Other	Neurofilament light chain (NfL) change.	Resting blood sample-Marker of neurodegeneration:	Baseline, after 24 weeks and after 48 weeks.
Other	Brain-derived neurotrophic factor (BDNF) change.	Resting blood sample-Neurotrophic factor.	Baseline, after 24 weeks and after 48 weeks.
Other	Insulin-like growth factor-1 (IGF).	Resting blood sample-Neurotrophic factor.	Baseline, after 24 weeks and after 48 weeks.
Other	C-reactive protein (CRP) change.	Resting blood sample-Inflammatory markers.	Baseline, after 24 weeks and after 48 weeks.
Other	Interleukin-6 (IL-6) change.	Resting blood sample-Inflammatory markers.	Baseline, after 24 weeks and after 48 weeks.
Other	Tumor necrosis alpha (TNF-alpha) change.	Resting blood sample-Inflammatory markers.	Baseline, after 24 weeks and after 48 weeks.
Other	C-terminal collagen cross-links (CTX) change.	Resting blood sample- Bone turnover markers.	Baseline, after 24 weeks and after 48 weeks.
Other	Type-1n-terminal propeptide (P1NP) change.	Resting blood sample- Bone turnover markers.	Baseline, after 24 weeks and after 48 weeks.
Other	Bone mineral density of the femoral neck and lumbar spine change.	Dexa scan.	Baseline, after 24 weeks and after 48 weeks.
Other	Body composition change.	Dexa scan- whole body scan.	Baseline, after 24 weeks and after 48 weeks.
Other	Cognition change .	Selective Reminding Test (memory) and Symbol Digit Modalities Test (processing speed).	Baseline, after 24 weeks and after 48 weeks.
Other	Nine step stair test change.	Time to climb a 9 step flight of stairs.	Baseline, after 24 weeks and after 48 weeks
Other	Six Spot Step Test (SSST) change.	SSST is a measure of walking ability, balance and coordination. Measured as the time to complete the course.	Baseline, after 24 weeks and after 48 weeks.
Other	Six-minute walk test (&MWT) change.	Distance covered on a 30 meter track during six minutes maximal walking. Distance covered each minute is noted.	Baseline, after 24 weeks and after 48 weeks.
Other	Timed 25-Feet Walk Test (T25FWT) change.	Time to walk 25 feet (normal walk and maximal walk pace).	Baseline, after 24 weeks and after 48 weeks.
Other	Short Physical performance battery change.	Composite score from Five Times Sit- to- Stand Test, Tandem Test and 3 meter walk test.	Baseline, after 24 weeks and after 48 weeks.
Other	Maximal Voluntary Contraction (MVC) change.	The following muscle groups are tested: Knee flexors, Knee extensors, Plantar flexor and Dorsal flexor.	Baseline, after 24 weeks and after 48 weeks.
Other	Rate of force development (RFD) change.	The following muscle groups are tested: Knee flexors, Knee extensors, Plantar flexor and Dorsal flexor.	Baseline, after 24 weeks and after 48 weeks.
Other	Dynamic Strength change.	The following muscle groups are tested: Knee flexors, Knee extensors, Plantar flexor and Dorsal flexor.	Baseline, after 24 weeks and after 48 weeks.
Other	Force Steadiness change.	Unilateral leg press	Baseline, after 24 weeks and after 48 weeks.
Other	Voluntary activation	Interpolated twitch technique applied on the quadriceps muscle	Baseline, after 24 weeks and after 48 weeks.
Other	Electromyography (EMG)	The following muscle groups are tested: Knee flexors, Knee extensors, Plantar flexor and Dorsal flexor.	Baseline, after 24 weeks and after 48 weeks.
Other	Grip strength change.	Measured by Hand Dynamoter.	Baseline, after 24 weeks and after 48 weeks.
Other	SF-12 change.	Patient Reported Outcome Measure.	Baseline, after 24 weeks and after 48 weeks.
Other	Pittsburg Sleep Qulity Index change.	Patient Reported Outcome Measure.	Baseline, after 24 weeks and after 48 weeks.
Other	Brief pain inventory change.	Patient Reported Outcome Measure.	Baseline, after 24 weeks and after 48 weeks.
Other	Baecke Physical Activity change.	Patient Reported Outcome Measure.	Baseline, after 24 weeks and after 48 weeks.
Other	HADS change.	Patient Reported Outcome Measure.	Baseline, after 24 weeks and after 48 weeks.
Other	EQ-5D change.	Patient Reported Outcome Measure.	Baseline, after 24 weeks and after 48 weeks.
Other	FES-I change.	Patient Reported Outcome Measure.	Baseline, after 24 weeks and after 48 weeks.
Other	Multiple Sclerosis Impact Scale (MSIS-29) change.	Patient Reported Outcome Measure (only applicable for people with MS).	Baseline, after 24 weeks and after 48 weeks .
Other	Modified Fatigue Impact Scale (MFIS) change.	Patient Reported Outcome Measure (only applicable for people with MS).	Baseline, after 24 weeks and after 48 weeks .
Other	12-Item MS walking Scale (MSWS-12) change.	Patient Reported Outcome Measure (only applicable for people with MS).	Baseline, after 24 weeks and after 48 weeks .
Other	Expanded Disability Status Scale (only applicable for people with MS).	The EDSS scale ranges from 0 to 10 in 0.5 unit increments that represent higher levels of disability. Scoring is based on an examination by a trained exercise physiologist.	Baseline, after 24 weeks and after 48 weeks.
Other	Nine hole peg test	Manual dexterity and upper body function	Baseline, after 24 weeks and after 48 weeks.
Other	Physical activity	Accelerometry (7 days ware time)	Baseline, after 24 weeks and after 48 weeks.
Primary	Percentage brain volume change.	Whole brain atrophy will be measured from MRI-scans.	Baseline, after 24 weeks and after 48 weeks.