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Power Training in Older Multiple Sclerosis Patients

Power Training in Older Multiple Sclerosis Patients

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04762342
Acronym
POTOMS
Enrollment
60
Registered
2021-02-21
Start date
2020-12-07
Completion date
2024-08-28
Last updated
2023-06-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

Multiple Sclerosis, Healthy aging, Exercise, Neuroprotection

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.

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.

Interventions

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

Sponsors

University of Southern Denmark
CollaboratorOTHER
University of Copenhagen
CollaboratorOTHER
University of Aarhus
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
Yes

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.

Design outcomes

Primary

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

Other

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

Countries

Denmark

Contacts

Primary ContactTobias Gaemelke, MSc
gaemelke@ph.au.dk+45 28264508

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 9, 2026