Clinical trial NCT04762342: Power Training in Older Multiple Sclerosis Patients
Official title: Power Training in Older Multiple Sclerosis Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
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
Lead sponsor: University of Aarhus
Sponsor class: OTHER
Collaborators: name: University of Southern Denmark
name: University of Copenhagen
First posted: 2021-02-21
Enrollment: 60
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Percentage brain volume change.
timeFrame: Baseline, after 24 weeks and after 48 weeks.
Secondary outcomes:
Other outcomes:
measure: Normalized gray and white matter volume change.
timeFrame: Baseline, after 24 weeks and after 48 weeks.
measure: Volume of the brain nucleis: thalamus, hippocampus, putamen, caudate, globus pallidus, corticospinal tract, cingulate gyrus, corpus callosum, cervical spinal volume, motor cortex
timeFrame: Baseline, after 24 weeks and after 48 weeks.
measure: Diffusivity of the brain nucleis: thalamus, hippocampus, putamen, caudate, globus pallidus, corticospinal tract, cingulate gyrus, corpus callosum, cervical spinal volume, motor cortex
timeFrame: Baseline, after 24 weeks and after 48 weeks.
measure: White matter fibre orientations
timeFrame: Baseline, after 24 weeks and after 48 weeks.
measure: Glial fibrillary acidic protein (GFAP) change.
timeFrame: Baseline, after 24 weeks and after 48 weeks.
measure: Neurofilament light chain (NfL) change.
timeFrame: Baseline, after 24 weeks and after 48 weeks.
measure: Brain-derived neurotrophic factor (BDNF) change.
timeFrame: Baseline, after 24 weeks and after 48 weeks.
measure: Insulin-like growth factor-1 (IGF).
timeFrame: Baseline, after 24 weeks and after 48 weeks.
measure: C-reactive protein (CRP) change.
timeFrame: Baseline, after 24 weeks and after 48 weeks.
measure: Interleukin-6 (IL-6) change.
timeFrame: Baseline, after 24 weeks and after 48 weeks.
measure: Tumor necrosis alpha (TNF-alpha) change.
timeFrame: Baseline, after 24 weeks and after 48 weeks.
measure: C-terminal collagen cross-links (CTX) change.
timeFrame: Baseline, after 24 weeks and after 48 weeks.
measure: Type-1n-terminal propeptide (P1NP) change.
timeFrame: Baseline, after 24 weeks and after 48 weeks.
measure: Bone mineral density of the femoral neck and lumbar spine change.
timeFrame: Baseline, after 24 weeks and after 48 weeks.
measure: Body composition change.
timeFrame: Baseline, after 24 weeks and after 48 weeks.
measure: Cognition change .
timeFrame: Baseline, after 24 weeks and after 48 weeks.
measure: Nine step stair test change.
timeFrame: Baseline, after 24 weeks and after 48 weeks
measure: Six Spot Step Test (SSST) change.
timeFrame: Baseline, after 24 weeks and after 48 weeks.
measure: Six-minute walk test (&MWT) change.
timeFrame: Baseline, after 24 weeks and after 48 weeks.
measure: Timed 25-Feet Walk Test (T25FWT) change.
timeFrame: Baseline, after 24 weeks and after 48 weeks.
measure: Short Physical performance battery change.
timeFrame: Baseline, after 24 weeks and after 48 weeks.
measure: Maximal Voluntary Contraction (MVC) change.
timeFrame: Baseline, after 24 weeks and after 48 weeks.
measure: Rate of force development (RFD) change.
timeFrame: Baseline, after 24 weeks and after 48 weeks.
measure: Dynamic Strength change.
timeFrame: Baseline, after 24 weeks and after 48 weeks.
measure: Force Steadiness change.
timeFrame: Baseline, after 24 weeks and after 48 weeks.
measure: Voluntary activation
timeFrame: Baseline, after 24 weeks and after 48 weeks.
measure: Electromyography (EMG)
timeFrame: Baseline, after 24 weeks and after 48 weeks.
measure: Grip strength change.
timeFrame: Baseline, after 24 weeks and after 48 weeks.
measure: SF-12 change.
timeFrame: Baseline, after 24 weeks and after 48 weeks.
measure: Pittsburg Sleep Qulity Index change.
timeFrame: Baseline, after 24 weeks and after 48 weeks.
measure: Brief pain inventory change.
timeFrame: Baseline, after 24 weeks and after 48 weeks.
measure: Baecke Physical Activity change.
timeFrame: Baseline, after 24 weeks and after 48 weeks.
measure: HADS change.
timeFrame: Baseline, after 24 weeks and after 48 weeks.
measure: EQ-5D change.
timeFrame: Baseline, after 24 weeks and after 48 weeks.
measure: FES-I change.
timeFrame: Baseline, after 24 weeks and after 48 weeks.
measure: Multiple Sclerosis Impact Scale (MSIS-29) change.
timeFrame: Baseline, after 24 weeks and after 48 weeks .
measure: Modified Fatigue Impact Scale (MFIS) change.
timeFrame: Baseline, after 24 weeks and after 48 weeks .
measure: 12-Item MS walking Scale (MSWS-12) change.
timeFrame: Baseline, after 24 weeks and after 48 weeks .
measure: Expanded Disability Status Scale (only applicable for people with MS).
timeFrame: Baseline, after 24 weeks and after 48 weeks.
measure: Nine hole peg test
timeFrame: Baseline, after 24 weeks and after 48 weeks.
measure: Physical activity
timeFrame: Baseline, after 24 weeks and after 48 weeks.
Locations:
city: Aarhus C
country: Denmark
facility: Tobias Gæmelke
Study officials:
affiliation: Exercise Biology, Department of Public Health, Aarhus University
name: Tobias Gaemelke, Msc
role: PRINCIPAL_INVESTIGATOR
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