Multiple Sclerosis
Conditions
Brief summary
The goal of this interventional study is to test the effect of the anti-inflammatory and neuroprotective effects of this supplementary training program that includes breathing exercises, cold exposure, and meditation in patients diagnosed with multiple sclerosis. Researchers will compare the effect to control groups of MS patients without intervention.
Interventions
COMBINATION_PRODUCTWim Hoff method
breathing exercises, cold exposure, and meditation
Sponsors
Comenius University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
* RRMS diagnosed according to the official 2020 McDonald's criteria, * age 18-55 years, * MS duration up to 10 years, * EDSS 1.0-5.5, * willingness to participate
Exclusion criteria
* relapse or corticosteroid treatment within 3 months prior to study enrollment * severe/unstable comorbidity
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| concentration of pro-inflammatory cytokines | 12 weeks | blood concentrations in pg/ml of • cytokines (interleukins - IL-1β, IL-6, IL-8, IL-10, IL-12p70, IL-17A, IL-18, IL-23, IL-33, interferons IFN-α2 and IFN-γ, tumor necrosis factor TNF-α, monocyte chemoattractant protein MCP-1) |
| concentration of markers of oxidative stress | 12 weeks | blood concentration in mmol/l of markers of oxidative stress (OS) - advanced glycation end products (AGEs), fructosamine, advanced oxidation protein products (AOPP), thiobarbituric acid reactive substances (TBARS), total antioxidant capacity (TAC), ferric reducing ability of plasma (FRAP), |
| concentration of NfL | 12 weeks | neurofilamen light chains |
| concentration of GFAP | 12 weeks | glial fibrillary acidic protein |
| concentration of ecDNA | 12 weeks | cell-free extracellular DNA |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| General Anxiety Disorder-7 | 12 weeks | level of anxiety |
| Expanded Disability Status Scale | 12 weeks | physical disability - score from 0.0 to 10.0 |
| Patient Health Questionnaire-9 | 12 weeks | assesses degree of depression severity |
| Timed 25-Foot Walk | 12 weeks | walking speed in seconds |
| Nine-Hole Peg Test | 12 weeks | finger dexterity in seconds |
| Symbol Digit Modalities Test | 12 weeks | cognitive status - score in 90s |
| Fatigue Scale for Motor and Cognitive Functions | 12 weeks | to assess multiple sclerosis-related fatigue |
Countries
Slovakia
Outcome results
None listed