COld Exposure With Controlled BReathing And Meditation in Patients With Multiple Sclerosis (COBRAMS)
COBRAMS
1 other identifier
interventional
50
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable multiple-sclerosis
Started Sep 2022
Longer than P75 for not_applicable multiple-sclerosis
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2022
CompletedFirst Submitted
Initial submission to the registry
January 23, 2024
CompletedFirst Posted
Study publicly available on registry
February 28, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2025
CompletedMarch 19, 2024
March 1, 2024
3.3 years
January 23, 2024
March 17, 2024
Conditions
Outcome Measures
Primary Outcomes (5)
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)
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),
12 weeks
concentration of NfL
neurofilamen light chains
12 weeks
concentration of GFAP
glial fibrillary acidic protein
12 weeks
concentration of ecDNA
cell-free extracellular DNA
12 weeks
Secondary Outcomes (7)
Expanded Disability Status Scale
12 weeks
Timed 25-Foot Walk
12 weeks
Nine-Hole Peg Test
12 weeks
Symbol Digit Modalities Test
12 weeks
Fatigue Scale for Motor and Cognitive Functions
12 weeks
- +2 more secondary outcomes
Study Arms (2)
intervention group
EXPERIMENTALcontrol group
NO INTERVENTIONInterventions
breathing exercises, cold exposure, and meditation
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- relapse or corticosteroid treatment within 3 months prior to study enrollment
- severe/unstable comorbidity
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Derer's University Hospital
Bratislava, 83305, Slovakia
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 23, 2024
First Posted
February 28, 2024
Study Start
September 1, 2022
Primary Completion
December 1, 2025
Study Completion
December 1, 2025
Last Updated
March 19, 2024
Record last verified: 2024-03
Data Sharing
- IPD Sharing
- Will not share