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Power Training in Older Multiple Sclerosis Patients

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	Yes
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	60 Years and Over
Gender	All

More Inclusion & Exclusion 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.

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT04762342
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	N/A
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	University of Aarhus
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Tobias Gaemelke, Msc
Principal Investigator Affiliation	Exercise Biology, Department of Public Health, Aarhus University
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Recruiting
Countries	Denmark
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Multiple Sclerosis, Sclerosis, Demyelinating Autoimmune Diseases, CNS, Autoimmune Diseases of the Nervous System, Demyelinating Diseases, Healthy Aging, Aging

Additional Details

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.

Arms & Interventions

Arms

Experimental: Training Group Multiple Sclerosis

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.

No Intervention: Control Group Multiple Sclerosis

Habitual lifestyle including standard care.

Interventions

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

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Tobias Gæmelke, Aarhus C, Denmark

Status

Recruiting

Address

Tobias Gæmelke

Aarhus C, , 8000

Site Contact

Tobias K. Gaemelke, Msc

[email protected]

+45 28264508

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