COld Exposure With Controlled BReathing And Meditation in Patients With Multiple Sclerosis (COBRAMS)

N/AActive Not RecruitingNCT06280573

Comenius University50 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Multiple Sclerosis

Interventions

Wim Hoff methodCOMBINATION_PRODUCT

breathing exercises, cold exposure, and meditation

Eligibility

Sex: ALLMin age: 18 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Derer's University Hospital

Bratislava, Slovakia

Outcomes

Primary Outcomes

concentration of pro-inflammatory cytokines

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)

Time frame: 12 weeks

concentration of markers of oxidative stress

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),

Time frame: 12 weeks

concentration of NfL

neurofilamen light chains

Time frame: 12 weeks

concentration of GFAP

glial fibrillary acidic protein

Time frame: 12 weeks

concentration of ecDNA

cell-free extracellular DNA

Time frame: 12 weeks

Secondary Outcomes

Expanded Disability Status Scale

physical disability - score from 0.0 to 10.0

Time frame: 12 weeks

Timed 25-Foot Walk

walking speed in seconds

Time frame: 12 weeks

Nine-Hole Peg Test

finger dexterity in seconds

Time frame: 12 weeks

Data from ClinicalTrials.gov

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